Appendix E:

Summary of Existing DHHS Programs

The Administration for Children and Families (ACF) is responsible for federal programs which promote the economic and social well-being of families, children, individuals, and communities. Through its Federal leadership, ACF sees: families and individuals empowered to increase their own economic independence and productivity; strong, healthy , supportive communities having a positive impact on the quality of life and the development of children; partnerships with individuals, front-line service providers, communities, American Indian tribes, Native communities, states, and Congress that enable solutions which transcend traditional agency boundaries; services planned, reformed, and integrated to improve needed access; and a strong commitment to working with people with developmental disabilities, refugees, and migrants to address their needs, strengths and abilities.

Administration For Children, Youth and Families -- Head Start

The Head Start Program offers comprehensive early childhood education, nutrition, health and social services, along with a strong parent involvement focus, to low-income children nationwide. The overall goal of the program is to bring about a greater degree of social competence in preschool children from low-income families. The recently funded Early Head Start initiative extends services to families with pregnant women, infants and toddlers. Asthma is addressed as part of this comprehensive program though educational practices and guides.

Public Health Practice

Public Education

The Head Start Bureau, located within the Administration on Children, Youth and Families (ACYF) under the Administration for Children and Families (ACF), supports local Head Start programs in implementing the Head Start Program Performance Standards related to health (which is broadly defined to include medical, dental, mental health and nutrition); promoting preventive health practices; and striving to improve health services delivery to Head Start children and families through coordination and collaboration with other Federal programs serving low-income children and families. The Bureau periodically sends health information to Head Start grantee and delegate agencies on a variety of topics, such as immunizations, Medicaid, and child nutrition.

The topic of asthma is generally or specifically discussed in two training guides developed through contract by ACF. Activities in the guides are intended for use by Head Start front line staff, management teams, and Head Start parents. Asthma is generally discussed in the guide Sustaining a Healthy Environment. The issue of second hand smoke and air pollution and its impact on young children is discussed in the guide. Asthma is specifically addressed in the training guide: Caring for Children with Chronic Diseases. This guide builds on staff capacity to make Head Start a safe, welcoming place to learn and play for children with chronic illness and their families, and offers skill building activities on individual planning to meet the special health needs of children with chronic conditions. After discussing the impact of chronic illness on the family and the principles of family-centered care, the guide puts into practice the information and skills learned by focusing on children with asthma.

Administration For Children, Youth and Families -- Child Care Bureau

The Child Care Bureau is dedicated to enhancing the quality, affordability, and supply of child care available for all families. The Child Care Bureau administers Federal funds to States, Territories, and Tribes to assist low income families in accessing quality child care for children while parents work or participate in education or training.

Public Health Practice

Community-Based Partnerships/Outreach & Access to Quality Care

The health of children in child care is a top priority of the Child Care Bureau(CCB). One of the major initiatives that the CCB has undertaken to promote healthy development of children is through its "Healthy Child Care America Campaign." The "Healthy Child Care America Campaign (HCCAC)" is a collaborative initiative between the Child Care Bureau and the Maternal and Child Health Bureau in partnership with the American Academy of Pediatrics to support linkages between child care and health in communities across the country to improve health and safety in child care. Forty-eight States, the District of Columbia, Puerto Rico and Palau have successfully launched Healthy Child Care America Campaigns. States and communities involved in these partnerships are developing innovative approaches to ensure the health of children, including utilizing the child care setting as an opportunity to provide preventive health services. Technical assistance is provided to States and communities through an agreement with the American Academy of Pediatrics.

The HCCAC Blueprint for Action outlines 10 steps that States and communities can take to either expand existing public and private services and resources or to create new services to link child care and health. One of the 10 steps specifically focuses on providing support to child care providers caring for children with special health care needs, including asthma.

The Child Care Bureau's National Child Care Information Center (NCCIC) disseminates information to the child care community on children's health related information. Earlier this year multiple copies of the Sesame Street: "A is for Asthma" video was disseminated to each State Child Care Administrator. The NCCIC website features health and safety resources and also "hotlinks" to health related organizations.

AHRQ supports research designed to improve the quality of health care, reduce its cost, and broaden access to essential services. AHRQ's broad programs of research bring practical, science-based information to medical practitioners and to consumers and other health care purchasers. Here are highlighted several asthma-related projects supported by the agency.

Research

Health Services and Outcome

AHRQ supports research on the quality and outcomes of asthma care. The AHRQ asthma program evaluates the efficacy and cost effectiveness of asthma management programs. AHRQ also supports the development of outcome measures to monitor the quality of asthma care delivered, quality of life, and patient satisfaction with the health care received.

AHRQ's principal efforts in asthma research are grants to study and improve the quality of care delivered to patients with asthma. The "Pediatric Asthma Patient Outcome Research Team (PORT) II" is a 5-year randomized clinical trial that will test the cost-effectiveness of the Guidelines designed to reduce asthma morbidity among children. AHRQ is sponsoring several other research projects to assess whether specific quality improvement approaches, being implemented in real-world clinical settings, are effective in helping clinicians better manage childhood and adult asthma in accordance with the Guidelines. One study is comparing the effects of an opinion leader training program to an organizational change intervention in managed care plans; another is comparing a continuous quality improvement approach in office-based care to routine care; a third is looking at guideline implementation in emergency care; and another is studying disease management strategies for adult asthmatics in Medicaid HMOs. Cost-effectiveness is being examined in several of these studies, which are also testing health outcome measures, such as number of symptom-free days, to identify how treatments affect children's daily lives. Another strategy for improving asthma care is to update aspects of the Guidelines that have been addressed by recent research. An AHRQ-supported Evidence-based Practice Center is examining recent research in five Guidelines areas.

In another effort, "Measuring Quality of Life in Children with Asthma," researchers are examining the relationship between a general multi-dimensional approach and a disease-specific approach to measuring quality of life in children with asthma.

The mission of ATSDR is to prevent exposure and adverse human health effects and diminished quality of life associated with exposure to hazardous substances from waste sites, unplanned releases, and other sources of pollution present in the environment. To specifically address asthma, the Agency does on-site investigations of communities where exposures have occurred to toxic substances which are known or suspected as contributing to asthma morbidity; it also conducts epidemiological studies to increase understanding of the effects of these toxic substances and provides education and outreach to communities and health care providers.

Research

Risk Factors/Triggers

ATSDR's research activities in the area of asthma fall into two broad program areas. The first is the investigation of human health effects in communities where citizens have been exposed to hazardous substances released from hazardous waste sites or other environmental sources. Communities have been expressing growing concern about perceived increases in asthma. Often atmospheric releases of hazardous pollutants include substances that are known or hypothesized contributors to asthma morbidity. For example, one recently completed investigation examined whether ambient emissions from a large municipal landfill (characterized by levels of hydrogen sulfide and odor) were associated with an increase in respiratory symptoms and a decrease in respiratory function among persons with asthma who live near the landfill. Another investigation examined the occurrence of asthma among children exposed to airborne emissions of toluene diisocyanate from a foam manufacturing facility. Enhanced ambient air monitoring in another community with multiple sources of high hydrogen sulfide emissions has enabled ATSDR to examine the relationship between hydrogen sulfide and hospital visits for asthma and other respiratory conditions.

The second broad program area is the conduct of epidemiologic studies to address important gaps in our understanding of the relationship between hazardous substances and seven priority health conditions. Lung and respiratory diseases, including asthma, are included among these seven priority health conditions. (The other conditions are: birth defects and reproductive disorders; cancer; immune function disorders; kidney dysfunction; liver dysfunction; and neurotoxic disorders). Two recently initiated projects, one with the Utah Department of Health and the other with the Massachusetts Department of Health, are examining the relationship between childhood asthma and exposure to hazardous substances. ATSDR also is supporting two projects with the New York State Department of Health to examine the relationship between asthma and toxic air pollution; one is specifically focused on asthma among children.

ATSDR supported health investigations typically involve a close partnership among ATSDR and the local and state health departments, state and Federal environmental agencies, and community groups and citizens. Through cooperative agreements with 23 state health departments, ATSDR is working to build the capacity of state health departments to address concerns related to specific Superfund sites. Often community health concerns include asthma. For several health investigations, local Community Assistance Panels have been established as a mechanism to establish open and ongoing communications with residents of the community.

Public Health Practice

Public Education

Many ATSDR products and services contribute to professional and public education regarding hazardous substances that have been associated with asthma. ATSDR has published toxicologic profiles that present critical assessments of current knowledge and emerging science relevant to hazardous wastes. Two that have focused on substances recognized as respiratory irritants include sulfur dioxide and hydrogen sulfide.

ATSDR and its partners have educated more than 4,000 primary care providers at 108 Superfund sites to diagnose, treat, and counsel people who may have been exposed to hazardous substances. The agency's health education and promotion activities have included continuing medical education for physicians on the relationship between asthma and the environment. Recent agency efforts have focused on the development of guidelines for the clinical evaluation of children who may have been exposed to hazardous substances. Asthma is one of several health endpoints of interest. In addition, a case study in environmental medicine is under development which focuses specifically on environmental asthma.

Other agency activities contribute to the reduction in human exposure to hazardous substances and thus potentially to the primary or secondary prevention of asthma. Public health assessments and related activities evaluate data and information on the release of hazardous substances into the environment to assess any current or future impact on public health, develop health advisories or other health recommendations, and identify studies or actions needed to mitigate or prevent human health effects.

The Centers for Disease Control and Prevention (CDC) is responsible for promoting health and quality of life by preventing and controlling disease, injury, and disability. In its half-century of successes working with partners across the nation and the world, CDC has been a leader and pioneer in detecting and investigating health problems, conducting research to enhance prevention, developing and advocating sound health policies, implementing prevention strategies, promoting healthy behaviors, fostering safe and healthy environments, and providing leadership and training in public health.

National Center for Chronic Disease and Health Promotion-Division of Adolescent and School Health

The vision of the National Center for Chronic Disease Prevention and Health Promotion is to enable all people in an increasingly diverse society to lead long, healthy, satisfying lives. The Center's mission is to: prevent death and disability from chronic disease; promote maternal, infant, and adolescent health; promote healthy personal behaviors; and to accomplish these goals in partnership with health and education agencies, major voluntary associations, the private sector, and other federal agencies.

Public Health Practice

School-Based Education

CDC is committed to promoting the most effective means the nation might use to prevent the major health and social problems that affect school-aged children and adolescents. It is estimated that more than 4 million children have asthma. This disease is one of the leading causes of school absenteeism, accounting for over 10 million missed school days per year. CDC's Division of Adolescent and School Health (DASH) has an existing framework that includes approximately 55 state and territorial departments of education and partnerships with 35 national nongovernmental organizations and their constituents who have the capacity to help schools implement effective school health programs. While the program does not currently focus on asthma, its partnerships are relevant to school based asthma initiatives.

National Center for Environmental Health

The mission of the NCEH is to provide national leadership, through science and service, to promote health and quality of life by preventing and controlling disease, birth defects, disability, and death resulting from interactions between people and their environment. Program highlights include a comprehensive ZAP Asthma program and related projects, building state infrastructure and capacity to enhance programs in asthma, as well as research on the effects of air pollution in Mexico City.

Research

Risk Factors/Triggers

NCEH has supported a variety of studies examining the effects of various air pollutants on the health of children in Mexico City, both asthmatic children and those not diagnosed with the disease. Different studies have varied their methods: one measures daily respiratory symptoms and peak flow, while others observed episodes of respiratory illness through diary questionnaires. Respiratory health and pulmonary function of the children studied were compared in all cases with air quality, especially levels of ozone and inhalable suspended particulates.

Asthma Management [Related topics: Community-based partnership and Outreach]

Environmental Control

ZAP Asthma, Atlanta, Georgia, seeks to show that a comprehensive approach to controlling asthma (access to quality medical care, reductions in allergens and patient education) will reduce the number of asthma hospitalizations for children. The program includes an intensive evaluation component; a physicians' advisory committee to improve clinician practices in diagnosing and treating asthma; community level health education efforts; and applied research. Unique features of the project are the extensive partnerships (public and private) formed to carry out the project and the hiring of local community health workers. Seventeen partners are involved--including the American Lung Association of Georgia, the City of Atlanta, health insurance companies, and Emory University.

Surveillance

In 1999, state health departments had the option of including a standard series of questions in the Behavioral Risk Factor Surveillance System to determine the prevalence of asthma among adults. This surveillance system uses the random digit dialing technique to provide state level information for a variety of health conditions and health related behaviors. In 2000, the questions on asthma prevalence will be asked in all states.

With funding from NIH and EPA, CDC has provided grants to four state health departments and two city health departments to devise model asthma surveillance systems, including uses of these data for program development and evaluation.

Public Health Practice

Family/Patient Education

To foster family and patient education in asthma, NCEH has funded the Asthma Intervention and Welfare Reform Project in Wisconsin. The purpose of this project is to bring public health expertise on asthma and welfare reform together to provide asthma education and management techniques to enable families enrolled in the welfare-to-work program to finish job training, enter and stay in the work force, and improve their quality of life.

Other -- State Capacity Building

In late 1997, CDC requested each state health officer to identify an individual in the health department (or health agency for some jurisdictions) to serve as the focal point for asthma activities in the health department. These individuals, known as asthma contacts, now number 55 and include officials from every state, the District of Columbia, two city health departments and two territorial health departments. During the first year of the program, CDC staff mailed material on asthma epidemiology, surveillance, treatment, and control at approximately monthly intervals. In February 1999 and February 2000, conferences were convened to identify appropriate asthma surveillance and control strategies and to share experiences in efforts to reduce the burden of asthma.

National Center for Health Statistics

The mission of the NCHS is to provide statistical information that will guide actions and policies to improve the health of the American people. As the Nation's principal health statistics agency, NCHS leads the way with accurate, relevant, and timely data. NCHS contributes to the body of asthma research through various national surveys of the American population.

Surveillance

The National Center for Health Statistics has a number of health information systems that provide data to monitor the impact of asthma on the American people. The purpose of these systems is to monitor a number of health issues; information on asthma is obtained as one of a broad range of adverse health conditions. The following are descriptions of the major data systems.

The main objective of the National Health Interview Survey (NHIS) is to monitor the health of the United States population through the collection and analysis of data on a broad range of health topics. This survey can display these health characteristics by many demographic and socioeconomic characteristics. The Basic Module, which is asked on one sample adult and one sample child in the household, contains specific questions that address asthma. Additional information that is available includes: information on household composition and sociodemographic characteristics; information for matches to administrative databases; and basic indicators of health status and utilization of health care services.

The goals of the National Health and Nutrition Examination Survey (NHANES) program are: to estimate the number and percent of persons in the U.S. population and designated subgroups with selected diseases or risk factors for selected diseases, to study the relationship between diet, nutrition and health, and to explore emerging public health issues. Respiratory diseases have been an important component of NHANES since the first survey was fielded in the 1960's. A medical history of respiratory and allergic symptoms, as well as previous diagnoses of asthma, have been included in the sample person questionnaire. In addition, lung function is assessed through spirometric testing in a mobile examination center. Auxiliary data on exercise, diet, occupation, tobacco use, and medication use are collected. In some surveys, allergic responses and exposure to tobacco smoke have also been assessed. The NHANES is designed to provide estimates in selected racial and ethnic populations.

One survey (National Hospital Discharge Survey) studies inpatient utilization of hospitals, including information on diagnoses, procedures, length of stay, expected source of payment, and patterns of use of care in hospitals. This survey has been used to monitor hospitalizations due to asthma among young and old. Another survey (National Ambulatory Medical Care Survey) collecting data on hospital care provides information on demographic characteristics of patients, patients' complaints, medication therapy, and types of health care professionals seen, among other factors. Some mortality surveys (National Mortality Followback Survey; National Vital Statistics System: Mortality Files) have focused on deaths attributed to asthma and have provided an opportunity to study socioeconomic differentials in mortality, associations between risk factors and cause of death, disability, and access and utilization of health care facilities in the last year of life. The NCHS has collected and published information on deaths and causes of death since the early 1930's. Monitoring the trend in asthma mortality among various age, racial and ethnic groups, and genders has been an important signal to alert the public health community to the increasing problem of asthma in the American population.

National Institute of Occupational Safety and Health

NIOSH is responsible for conducting research and making recommendations for the prevention of work-related illnesses and injuries. Asthma that is either initiated or significantly worsened by job environments is a major focus of the NIOSH research and surveillance program.

Research

Natural History of the Disease

Asthma is one of the top priorities for research in the U.S. over the next decade, as defined by the National Occupational Research Agenda (NORA). Recent investigations of work-related asthma include health hazard evaluations of workplaces in which the new onset of asthma has been reported in relation to airborne and dermal exposures from chemicals, metals, animal and vegetable products, as well as organic composts and metal working fluids (both of which often are contaminated by biological agents). Additional studies are evaluating the incidence, risk factors, and natural history of asthma in groups of workers working in exposure settings with a previously recognized asthma risk, such as aluminum reduction, wood products manufacturing, insect rearing, and health care (natural rubber latex). Exposures to many of the implicated workplace agents are also common in the home and other settings, although at generally lower levels. Exposure-response relationships in the workplace may be more easily investigated due to the larger range of exposures and more accurate classification of exposure levels. Multiple reports in the occupational literature document that timely and adequate control of exposures in individuals with work-related asthma can at times result in complete cessation of asthma symptoms and findings. To further delineate the conditions required for asthma onset and cessation, NIOSH has ongoing investigations addressing improved methods for characterizing and quantifying exposures to chemical sensitizers (e.g. isocyanates and certain metals), protein antigens (natural rubber latex, insect and crab proteins), and other organic materials, such as endotoxins.

Pathogenesis and Mechanisms (also risk factors/triggers)

NIOSH is currently investigating the pathobiological mechanisms of asthma, including markers of responses, utilizing in vitro preparations, in vivo animal models of asthma, and observational studies of exposed workers and their blood and nasal fluids. Both dermal and inhalation exposures to natural rubber latex and isocyanates are under investigation in the laboratory, also in conjunction with observational studies in exposed workers.

Prevention

A large scale intervention trial is evaluating primary asthma prevention in health care facilities through a comprehensive program of reduction in worker exposures to powdered natural latex gloves, with concurrent monitoring of several health outcomes, as well as skin and airborne antigen exposures. Methods for medical screening, and early detection of asthma are being investigated in groups of workers with various potential asthma-inducing exposures, as secondary prevention methods.

Surveillance

Components of several ongoing NIOSH activities involve surveillance of asthma. The Health Hazard Evaluation Program responds to requests from workers and managers for workplace investigations, and in recent years, multiple complaints related to asthma symptoms have been investigated. NIOSH has funded state-based demonstration projects for occupational asthma surveillance systems. Data collection from this surveillance is ongoing, and assists in the identification of high risk exposures and the recognition of new environmental causes of asthma. Additionally, currently funded projects are addressing population-based asthma surveillance and evaluating the role of occupational environments and other exposures in asthma incidence, prevalence, and severity.

Public Health Practice

Management Guidelines

NIOSH has ongoing involvement in the development of asthma management guidelines. Institute representatives continue active involvement with the National Asthma Education and Prevention Program and the American Thoracic Society in the development of professional guidelines for the evaluation and management of asthma, with emphasis on the recognition and management of occupational and environmental exposures. Certain

NIOSH publications also offer management guidelines for asthma in relation to specific workplace exposures, including natural rubber latex, isocyanates, and laboratory animals.

Clinician Education

Limited programmatic support is currently offered to a health care provider association for the development of clinician education and print/electronic information resources, to assist providers in the recognition and management of occupational and environmental triggers in asthma patients.

FDA is a public health agency, charged with protecting American consumers by enforcing the Federal Food, Drug, and Cosmetic Act and several related public health laws. FDA examines the results of studies done on products by the manufacturer, and ensures that these products meet certain safety standards. The FDA has programs investigating allergy and asthma-related devices, drugs, and diagnostic and therapeutic allergen vaccines.

Center for Drug Evaluation and Research

Policy/Regulatory

Asthma Management -- Pharmacotherapy

CDER, primarily through the Division of Pulmonary Drug Products, works in partnership with pharmaceutical sponsors to facilitate the timely development and approval of safe, effective, and high quality drug products for the treatment and/or prevention of asthma. CDER also is involved in facilitating the development and approval of drugs such as: the first non-chlorofluorocarbon (CFC) propelled metered-dose inhaler (MDI) for the treatment of asthma, and three new multi-dose dry powder inhalers (DPIs) for the treatment of asthma. Efforts also include the improvement of drug labeling for children.

Center for Biologics Evaluation and Research

Policy/Regulatory

Risk Factors/Triggers

Allergens found in house dust emanating from cats and dogs, cockroach, molds, rodent allergens, and house dust mites are recognized as important sensitizers/triggers of asthma in allergic individuals. Extracts from these source allergens are currently FDA approved both for use in diagnosis of asthma triggers/sensitizers by means of allergy skin testing and asthma treatment by means of allergy injections to reduce airway reactivity to the allergen trigger identified. The Public Health Service Act requires allergens licensed by the FDA to meet potency standards. To date, in compliance with the Act, CBER research initiatives have developed U.S. Standards of Potency for house dust mites and cat. These standardized allergenic extracts are licensed by CBER for sale in the U.S. for diagnosis and immunotherapy of hypersensitive asthmatics whose symptoms are elicited following exposure to these allergens. Licensed allergenic extracts are accompanied by adequate directions for use in diagnosis and treatment via FDA approved package inserts and labeling. Standardization increases the value of information available to patients and physicians, reduces the risk of incorrect dosing, reduces the risk of inadvertent allergen overdose and serious side effects. Standardization also permits scientific studies that are predictable, replicable, and can be extrapolated. In contrast to standardized allergenic extracts of cat and house dust mite, allergen extracts licensed by FDA of cockroach, dog, mold, and rodent allergens are currently nonstandardized.

CBER is planning to develop U.S. Standards of Potency for cockroach and mold. CBER will support the conduct clinical trials using cockroach and/or mold allergen vaccines meeting U.S. Standards of Potency to determine their safety and efficacy in the diagnosis and immunotherapy of cockroach- and mold-induced asthma.

HCFA is the federal agency that administers Medicare, Medicaid, and the State Children's Health Insurance Programs. HCFA's asthma work includes research and monitoring of care provided to Medicare beneficiaries through Medicare Peer Review Organizations. The goal of these activities is to improve access to care and outcomes of health services delivery for patients using HCFA's services.

Research

Using Medicaid and Medicare data, HCFA's extramural and intramural research related to asthma includes: tracking: the disease, the frequency of services, risk factors, and other factors involved in a person's medical and environmental history of asthma treatment, and assessing the quality of asthma-care provided to program beneficiaries. Also, when feasible, the analyses include comparisons with other populations. The data sets being analyzed are Medicare administrative claims files and the Medicare Current Beneficiary Survey (MCBS); and the Medicaid eligibility and claims files, and certain medical records. When feasible, HCFA's research uses the Guidelines for Diagnosis and Management of Asthma (NHLBI: Expert Panel Report 2, "Guidelines") as a framework for studies, and in other instances, as criteria for quality of care measurement.

HCFA funded a substantial portion of the RAND work in the development of global quality of care, asthma-related indicators for women under fifty years of age and for

children who receive their services through a managed care environment. The indicators were completed in 1999.

Quality and Outcome of Care

HCFA's program on quality of care for Medicaid children with asthma includes access to care factors and proxies. This aspect of HCFA's research program on asthma is based on the theory that if Medicaid children have adequate and timely access, then their severity and repetition of acute episodes may decrease, and the outcomes of their care improve.

HCFA has a small program on quality and outcomes of care among Medicaid children with allergic asthma. This asthma program is part of HCFA's assurance that its beneficiaries receive appropriate and timely health and illness care.

Public Health Practice

Management Guidelines

Two HCFA Medicare Peer Review Organizations participate in the Agency's asthma program through a state-wide project aimed to verify that physicians treating asthma in Medicare patients do so in accordance with the Guidelines.

Family/Patient Education

The Medicare Peer Review Organizations also aim to verify that patient education is being provided for proper administration and use of prescribed medication, and the use of peak flow meter home monitoring in accordance with the Guidelines.

-Quality of Delivery Systems

HCFA and AHRQ funded an NCQA Pediatric Health Plan Assessment Task Force that identified gaps in HEDIS quality performance measures. The work was completed in 1999. The new HEDIS asthma measure, which now includes children and adults, is being tested. Managed care organizations with contracts to provide services to Medicaid beneficiaries are among the entities responding to NCQA during this testing phase. Also, HCFA participates in the NCQA Committee on Performance Measurement with input into the HEDIS measures.

HRSA directs national health programs which improve the health of the Nation by assuring quality health care to underserved, vulnerable and special-need populations and by promoting appropriate health professions workforce capacity and practice, particularly in primary care and public health. HRSA programs are designed to promote comprehensive primary care education and practice, and to support the Nation's public health infrastructure. The management of asthma is addressed through several programs which provide resources and services for broad health improvement, especially in vulnerable groups.

Research

General

The Bureau of Primary Health Care (BPHC) collaborates with AHRQ on the development of health center practice based research networks. One of the practice based research projects focuses on asthma. There are four phases to this research: descriptive studies, epidemiological studies, clinical outcome studies and intervention trials. Currently, the project is beginning the second phase of work.

Health Services and Outcomes

BPHC has developed an evaluation and research strategy to measure health outcomes in the underserved population through health center effectiveness studies, and it has developed a quality improvement strategy to improve health outcomes and disseminate breakthrough changes (see section on "Access to Quality Care.")

Health Services

Clinician Education

The Bureau of Health Professions provides support for major training programs in general internal medicine, general pediatrics, family medicine, geriatrics, advanced nurse/nurse practitioner education, and for physician assistants; and for interdisciplinary training through rural health and area health education centers. All of these efforts include management of patients with asthma in the context of comprehensive primary care services.

Access to Quality Care

BPHC supports several major programs to increase access to comprehensive primary and preventive health care for underserved and vulnerable populations. Critical health professional provider needs of underserved areas are addressed through the National Health Service Corps. Essential health services for vulnerable populations of homeless, migrant farm workers, public housing residents, and others, are targeted through the Consolidated Health Centers Program. Although not specific to asthma, these activities forge community-based partnerships and encourage outreach to manage acute and chronic health problems.

Comprehensive primary care services in Health Centers include the treatment of asthma. In addition to providing both primary care, appropriate specialty referral, and hospitalization for these patients, health centers provide critical enabling services that are key for asthma care. These services include case management, environmental health risk reduction, health education, outreach, transportation, and interpretation and translation services. In addition, health centers operate over 200 primary care sites in schools, and most health centers provide pharmacy services.

BPHC, in collaboration with the Institute for Healthcare Improvement (IHI), the Environmental Protection Agency (EPA), the Agency for Toxic Substances and Disease Registry (ATSDR) and public and private agencies, has launched an aggressive, innovative program to address the growing health disparities and a changing market place. Beginning in February 2000, 20-25 health centers, including school based health centers and free standing National Health Service Corps will participate in a Health Status and Performance Improvement on Providing More Effective Care for Adults and Children with Asthma. This effort seeks to 1) generate and document improved health outcomes for the underserved population with asthma 2) transfer knowledge about how to promote positive breakthrough changes; and 3) develop infrastructure, expertise, and leadership to support and drive improved health, access, and cost outcomes.

Health Centers participating in the Collaborative select teams to attend three learning sessions and they receive ongoing support from IHI to make accelerated improvements in the care they give to patients with asthma. Examples of measures include, symptom free days, reduction in certain environmental exposures, emergency department visits for asthma, and treatment with maintenance anti-inflammatory medication.

The collaborative emphasizes team cooperation to obtain optimal patient care outcomes. Teams submit monthly reports which 1) document their performance on key patient care measures, and 2) assess their progress as a team. Attainment of these goals depends upon continual learning, improvement, change, and expansion of partnerships at the local, state, and national levels.

Community-based Outreach

The Maternal and Child Health Bureau provides block grants to the States and administers discretionary grants to support the Nation's maternal and child health infrastructure. Of special relevance to management of asthma patients, and community-based partnerships and outreach, are two program areas. One supports the development of systems of care and services for children with special health care needs, including those at risk for or suffering from chronic illness and disabilities. The other comprises interdisciplinary training of professional health personnel, including working through pediatric pulmonary centers to improve community-based care for children with chronic respiratory diseases (such as asthma) and their families.

The mission of the IHS is to raise the physical, mental, social, and spiritual health of American Indians and Alaska Natives to the highest level. IHS aims to assure that comprehensive, culturally acceptable personal and public health services are available and accessible to American Indian and Alaska Native people. The bulk of IHS's asthma-related activity is in clinical care, but another important aspect of their activity is in fostering asthma research. IHS plays a critical role in collaboration with outside researchers looking at conditions that affect specific tribes.

Research

General

The function of IHS regarding research is to serve as a liaison between outside researchers, which are mostly academic institutions (e.g. University of New Mexico, University of Arizona, University of Washington, the Strong Heart Study), and tribes. In addition to bringing together tribal communities, IHS (with individual and tribal approval) assists the researchers with clinical health data to be integrated into the research. IHS also provides a unique dimension to the Institutional Review Board (IRB) process. Not only does it serve to protect individual subjects; the IHS IRB also requires that research is approved by the tribes served by IHS facilities involved in research. In these ways, the IHS provides in-kind support promoting research to the extent that it will benefit the tribes. Working with a number of universities, IHS has provided assistance in respiratory research affecting tribal populations, and in surveillance documenting long term increasing trends in asthma incidence in tribal communities in New Mexico, Arizona, Washington State and Alaska.

Health Services

Community-Based Partnership/Outreach

The bulk of IHS's asthma-related activity is in delivery of health care to tribes. In addition to providing asthma treatment as part of standard care, IHS has helped to establish several specialty clinics focused on asthma. For example, Children's Medical Services of New Mexico developed special community-based asthma clinics and a Children's Hospital-based family education program for families of Indian children with asthma. The University of Washington is working with several health centers serving

American Indian and Alaska Native communities to promote excellence in clinical asthma services.

The mission of the National Institutes of Health (NIH) is to uncover new knowledge that will lead to better health for everyone. NIH works toward that mission by: conducting research in its own laboratories; supporting the research of non-Federal scientists in universities, medical schools, hospitals, and research institutions throughout the country and abroad; helping in the training of research investigators; and fostering communication of biomedical information.

National Heart, Lung, and Blood Institute

NHLBI plans, conducts, fosters, and supports an integrated and coordinated program of basic research, clinical investigations and trials, observational studies, and demonstration and education projects. NHLBI has many programs directly targeting asthma; the Institute conducts and sponsors extensive research efforts aimed at understanding all aspects of the disease, including mechanisms, genetics, environmental and other factors, and drug therapy. There is also a strong emphasis on Demonstration and Education. The National Asthma Education and Prevention Program, coordinated by NHLBI, has published the widely distributed "Guidelines for the Diagnosis and Management of Asthma." and undertakes extensive education and outreach efforts to help translate the latest scientific understanding of asthma into practice.

Research

Natural History of the Disesase

Epidemiological studies funded by the NHLBI include longitudinal studies focused on identifying the risk factors associated with the development of asthma and asthma-like-symptoms during childhood and young adulthood. Such research has helped identify phenotypes, or characteristics of asthma among populations, that may reveal new hypotheses about the mechanisms of asthma. Recent studies of young children, for example, raise new questions about the role of respiratory infection in the onset of asthma. There is a well established association of respiratory viral illness and exacerbations of asthma, and it has long been thought to be a cause of asthma in all ages and particularly in young children.

Current epidemiologic studies indicate that there are two different patterns of wheezing with viral illness in young children--many of whom do not have continued asthma symptoms after 6 years of age. The data support the intriguing suggestion that rather than causing the onset of asthma, some respiratory viruses may protect some young children. In this view, asthma may be a result of an altered developmental pattern of both the lungs and the immune system. Two major research initiatives undertaken by NHLBI in FY98 are exploring the role of respiratory infections in asthma and the mechanisms underlying risk factors of the onset of asthma in early life.

Other epidemiologic studies supported by the NHLBI are identifying the factors, such as environmental exposures, that influence the rate of decline in pulmonary function and increased hyperresponsiveness in older adults. Epidemiologic studies are also assessing the separate and interactive effects of asthma severity, job characteristics, psychosocial and other factors on asthma disability.

Epidemiologic studies on the natural history of asthma focus on identifying factors that are associated with the risk of severe asthma and asthma related death. Recent statistics on asthma morbidity and mortality underscore that African-Americans and Puerto-Rican Hispanics have a disproportionately high risk of asthma related hospitalizations and deaths. Socioeconomic factors and access-to-health care factors are most likely involved, but research on how genetic, immunologic, and environmental factors contribute --either independently or together -- to asthma onset and severity will elucidate other risk factors for these populations.

Pathogenesis and Mechanisms

A major portion of NHLBI supported research in asthma is devoted to identifying and examining the underlying pathogenesis and basic mechanisms of the disease. Through this research, appropriate targets for treatment to stop, and ultimately reverse, the asthmatic process can be developed. A major focus of studies is the dissection of the cellular and molecular events which appear to initiate, direct, and perpetuate the development of airway inflammation in response to both immunologic and non-immunologic stimuli. For example, studies are examining specific inflammatory cells such as thymus-derived lymphocyte (T-Cell) abnormalities and their interaction with each other and with resident airway cells such as cytokines and inflammatory mediators. This research will define the mechanisms that underlie the selective migration of inflammatory cells to the airways. Research is also directed at establishing the mechanisms of neural control of bronchoconstriction and airways, hyper-responsiveness in asthma, as well as the mechanism involved in the integrated regulation of airway and blood vessels in the lung by neural reflex control. Studies are also determining the sequence of biochemical

events generating and regulating hypersecretion in inflamed airways, a common feature of asthma.

Genetically engineered murine models are being developed and used to explore immune and inflammatory responses in the lung that are relevant to asthma. This research exploits the findings that a number of proteins including cytokines, adhesion products, growth factors, and membrane ion channels act as pivotal elements in asthma. Since the ability to address questions in a mechanistic manner and to manipulate the system in

humans are limited, many studies are performed with mammalian models alongside clinical studies.

Another promising area of NHLBI supported research are studies directed at understanding the cellular and molecular mechanisms regulating the function of receptors found in the walls of the airways (e.g. beta-adrenergic receptors) and other receptors. For example, evidence suggests that a defect in beta-adrenergic receptors could contribute to the development of asthma and may lead to a more severe clinical course for the disease.

Research into the mechanisms contributing to the persistence, or chronicity, of asthma is focused on the nature of the repair process in the airway wall and the remodeling of the airway epithelium and airway smooth muscle.

Neuroregulation of the airway is another mechanism that influences the nature and severity of asthma. Immunological and neural factors have been investigated independently, but now research indicates that these two processes are interrelated. It appears that stimulation of sensory nerve endings within the airways leads to production and release of substances that cause inflammation. Moreover, stress has been shown to play an important role in asthma but its role is not well understood. Intriguing early studies suggest that interdisciplinary research in the pscyho-immuno-neurological aspects of asthma may reveal new insights about the mechanisms of asthma. Further studies in both epidemiologic and basic research are assessing the importance of stress in terms of the timing of disease onset, potential interactions with allergens, and interaction with other factors that may influence the onset of the disease and how it is expressed. In addition, investigation of the role of neural and immunologic factors in chronobiology of asthma, including nocturnal asthma may lead to a better understanding of risk factors of asthma related death, since studies suggest that there is an association between asthma that worsens at night and asthma severity and deaths.

The NHLBI supports six Specialized Centers of Research in the Cellular and Molecular Mechanisms of Asthma. Through multidisciplinary basic and clinical investigations, these centers are poised to provide major scientific advances in understanding the interaction and integration of various inflammatory, immunologic, and neural process and how they cause the clinical syndrome of asthma.

Genetics

Currently, a genome-wide search, sponsored by the NHLBI with participation of the NIAID, is underway to identify all the various genes that confer susceptibility to asthma, with the NHLBI-supported Mammalian Genotyping Service involved in defining the chromosomal regions influencing the complex phenotypes in asthma in humans. Early findings from these studies confirm that multiple genes may be involved in asthma and that they may vary between ethnic/racial groups. Examination of known candidate genes

in the regions of linkage support the concept that the pathophysiology of asthma may involve genetically determined changes in inflammatory pathways and T cell signaling.

With the support of the NHLBI, researchers have identified individual genes affecting airway hyperresponsiveness in bred mouse strains. Also, studies of human pedigrees using a candidate gene approach, have reported evidence for specific genes influencing asthma or atopy.

Additional genetics research supported by the NHLBI include the fine mapping of initial linked regions found to influence asthma and positional cloning to characterize the precise alleles that confer risk. The goal is to delineate the genes and mutations involved in the development of allergy and asthma and to explore specific gene-environment interactions that lead to asthma and different clinical manifestations of the disease

An exciting new area of research supported by NHLBI is pharmacogenetics research, in which genetically determined factors influence individual response to pharmacologic therapy. For example, current studies are exploring the role of beta-adrenergic polymorphisms in a diminished response to beta-agonist medication.

Prevention

Primary prevention of asthma should be achievable. As noted in the "Natural History and Epidemiology" and "Pathogenesis and Mechanisms" sections, recent studies supported by the NHLBI are leading to insights into the mechanism of asthma and risk factors for the onset of asthma that will suggest promising avenues for future research. Two large research initiatives launched by the NHLBI in FY 1998 will promote identification of the most promising targets for future interventions to prevent the onset of asthma. These are Request For Application (RFA): "Role of Respiratory Infections in the Development of Childhood Asthma," which is co-sponsored by NIAID, and RFA: "Origins of Asthma in Early Life." The research will include studies that: investigate at what point in the cellular events can the chain of inflammatory events be interrupted; use animal models to explore the interaction of viruses and antigen sensitization; and help identify if there is a "preasthma" state in early childhood during which exposure to respiratory infection or environmental allergens bring about asthma in genetically predisposed, at-risk individuals.

Asthma Management

The NHLBI supports a variety of studies that investigate new drug therapies, evaluate the effectiveness of existing therapies, both pharmacologic and non-pharmacologic (e.g. environmental control measures), on asthma management, and explore the effect of therapies on the course of the disease. The studies include clinical research and demonstration and education research.

Environmental control

The NHLBI supports several studies that assess the effectiveness of reducing exposure to known allergens and environmental tobacco smoke on reducing asthma symptoms, emergency department visits, and hospitalizations. Current studies focus on reducing exposures among children with asthma, especially children in low income urban areas since such exposures have been associated with disproportionately more severe disease in these areas.

Pharmacotherapy

The NHLBI supports several large clinical research programs devoted to studying the long term effects of asthma medications and to examining the potential effectiveness of novel new treatments. The Childhood Asthma Management Program, a multi center clinical trial with over 1,000 children will provide critical information about the long term effects and safety of three key therapies in childhood asthma.

The Asthma Clinical Research Network provides an infrastructure for the rapid completion of multiple therapeutic trials in well characterized populations of patients with asthma and for the timely communication of results to the medical community. This research of the Network helps resolve current clinical controversies in asthma management.

In partnership with other Institutes within NIH, including NICHD, NHLBI supports clinical trials among women with asthma to identify the treatments that will lead to the both effective management of asthma during pregnancy and healthy pregnancy outcomes.

Several clinical studies build on the results of studies on the basic mechanisms of asthma. For example, the recent development of anti-leukotrienne medications, the first new class of medication to become available in over 10 years, is based on basic research that identified the critical role of leukotriennes in the inflammatory process of asthma.

Monitoring

Investigations supported by the NHLBI are examining the relative merits of peak flow monitoring or symptom monitoring for guiding day-to-day therapeutic decisions. There is some evidence that a subgroup of people with asthma may be at greater risk of severe and even life-threatening asthma exacerbations because they are unable to perceive symptoms of increasing airflow obstruction. Ongoing studies are attempting to define factors that contribute to poor symptom perception (e.g., gender, neurologic, psychosocial, physiologic, circadian rhythms), and what factors may be amenable to intervention.

Education and Outreach

NHLBI demonstration and education (D&E) research evaluates educational and behavioral approaches and environmental and organization strategies that may improve the prevention or management of asthma. D&E studies have demonstrated the effectiveness of teaching self-management strategies to patients of all ages. Current research focuses on identifying what elements of the education are most essential and what methods or combination of methods will promote the most efficient use of patient and clinician efforts: group vs. individual education, use of interactive multi-media, separate asthma education vs. education that is integrated into routine primary medical care; and adjunctive education in the community setting. Research is also underway to determine more effective ways to promote a partnership between the health care professional and the patient, especially in the managed care environment. A related issue is research on training health care professionals and disseminating the new advances in asthma management throughout the medical community.

A major thrust of recent D&E research has been on identifying appropriate strategies for extending the benefits of asthma management strategies to populations that have been traditionally harder to reach, for example, minorities and economically disadvantaged children. These are the populations that are at greatest risk for more serious disability due to asthma and asthma related death. Outreach educational programs using non-medical settings --the school, community neighborhood centers, an peer education-home visitors are testing the use of culturally sensitive behavior change strategies for children with asthma and their families. Others studies evaluate specific asthma management interventions, for example, programs to reduce smoking among parents of children with asthma and programs to promote continuous, comprehensive management of asthma rather than episodic emergency care.

Because children under 18 years of age have experienced a dramatic increase in asthma prevalence and morbidity in the last 10 years, and children with asthma miss twice as much school as the national average, the NHLBI has launched a new initiative "Interventions to Improve Asthma Management and Prevention at School" to develop and evaluate innovative asthma management and prevention programs that incorporate all components of a comprehensive school health program.

Public Health Practice

The NIH has established programs to translate the findings of NHLBI-supported research into effective tools to educate health providers, patients, and the public. The National Asthma Education and Prevention Program (NAEPP), coordinated by the National Heart, Lung, and Blood Institute (NHLBI), is responsible for translating research on asthma into practical health education materials and tools for use by health professional, patients, and the public. The NAEPP was initiated in March 1989 to address the growing problem of asthma. The goal of the NAEPP is to reduce asthma-related morbidity and mortality and to enhance the quality of life of asthma patients.

The NAEPP works with a wide range of organizations to conduct asthma educational interventions. A group of 38 professional, voluntary health, lay, and governmental organizations involved with asthma form the NAEPP Coordinating Committee. The coordinating committee advises the program and the members assist in activities to achieve the goal of the program. These coordinating committee organizations help communicate to their members the key messages the NAEPP is trying to convey.

The NAEPP designed a model web-based system to improve the diagnosis and management of asthma. The site provides virtually all the scientific literature on chronic asthma that has ever been published, as well as practical information for clinicians, patients, and public health professionals. See www.nhlbi.nih.gov.

Management Guidelines

The first major activity of the NAEPP was the development of Guidelines for the Diagnosis and Management of asthma in 1991. Subsequently, the NAEPP has been working with its partners to implement the guideline recommendations and to disseminate education materials and programs based on those guidelines, particularly to health care professionals and asthma patients. An update of those guidelines was produced in 1997--Expert Panel Report 2: Guidelines for the Diagnosis and Management of Asthma. Major attention is now devoted to promoting use of the Guidelines, including in managed care organizations.

Clinician Education

The NAEPP Coordinating Committee has organized a series of partnership activities to facilitate the implementation of the new guideline recommendations in various clinical settings. The NAEPP has enlisted its members to become actively involved in not only disseminating the new treatment guidelines, but also in encouraging clinicians to adopt the guideline recommendations and use them in caring for their patients. For example, the NAEPP is working with the American Academy of Allergy, Asthma, and Immunology (AAAAI) to develop a multi-faceted program to help all clinicians who care for children with asthma learn about and adopt the recommendations in the updated guidelines. A summary guide, based on the 1997 Expert Panel Report 2 Clinical Practice Guidelines, but tailored to the needs of primary care physicians, is being sent to pediatricians, family physicians, and nurses practitioners around the country. The practical guide will be the centerpiece for numerous continuing education programs.

The NAEPP and the American College of Chest Physicians organized a conference on asthma management for managed care organizations (MCO), especially those receiving Medicaid funding. As a result of this partnership effort, a number of organizations have agreed to participate in a year-long process to improve asthma outcomes using the guidelines and to document their results. Further examples of partnership activities to promote dissemination and adoption of Clinical Practice Guidelines includes projects with the National Medical Association to develop pocket guides for resident trainees, development of a nurses guide for managing asthma, and a guide delineating the role of pharmacists in asthma care.

Future plans in clinician education include replicating successful strategies in additional managed care organizations, as well as public health organizations and other communities. Activities at the local, State, and national levels will facilitate the adoption and use by health care providers of the most effective therapies available for the management of asthma and thereby help to improve the quality of life of asthma patients and their families.

Family/Patient Education

The NAEPP has produced an extensive array of patient and public education materials in both English and Spanish to help patients and their families increase their asthma self-management skills.

Public Education

The NHLBI continues to implement a strong, vibrant public education campaign to increase awareness of warning signs and symptoms of undiagnosed asthma. The campaign's key message focuses on encouraging those who experience signs and symptoms of asthma to see their doctor or health care provider for treatment. Future campaigns will emphasize the expectations patients with asthma should have for their asthma to be well-controlled. The public health education efforts are accentuated by far-reaching partnerships with the private sector, advertising media and radio networks, as well as local governments to disseminate critical and life-saving messages of the NAEPP mass media campaign.

School-Based Education

The NAEPP has developed a comprehensive set of materials to promote appropriate management of asthma in the school setting. A guide for school personnel delineates activities that each member of the school team perform in order to help students with asthma follow their asthma management plans and participate fully in school activities. A video and accompanying pamphlet provides guidance to teachers and physical education instructors to enable and encourage children with asthma to be physically active. Policy statements, prepared in partnership with the American Association of School Board Administrators and the American Association of School Health have been produced outlining measures to assure student access to medications and a school environment that is "asthma friendly" --i.e. supportive of the students with asthma.

Community-Based Partnership/Outreach

The NAEPP is collaborating with local community-based asthma coalitions to get the messages of the new guidelines disseminated and used at the local public health level. The NHLBI has supported the development of several community based coalitions on asthma, and is currently working with a variety of community groups around the country that deal directly with asthma problems at the local level and strive to coordinate community efforts to address the problems. In this work, the NAEPP provides technical assistance and a vital network for exchanging information and advice on organizing and maintaining community coalitions for asthma. The coalitions are composed of members from local public health departments, local hospital/medical centers, schools, community recreation centers, concerned parents groups, lung associations, and local media. The NAEPP and the coalitions will jointly develop public education objectives and implement a strategic plan to not only increase public awareness, but also to increase asthma management skills of patients and their families. Such efforts will provide synergy and will increase the penetration of important asthma education messages to communities at high risk of asthma morbidity and mortality.

Quality of Delivery Systems

The NAEPP, in partnership with the National Commission on Quality Assurance and the American College of Chest Physicians, provides conferences and training programs in the development of quality improvement disease management programs. Based on the work of the NAEPP Cost Effectiveness Task Force, the partnership efforts are developing performance measures for health care purchasers to use in evaluating asthma care services.

National Institute of Allergy and Infectious Diseases

NIAID provides the major support for scientists conducting research aimed at developing better ways to diagnose, treat and prevent the many infectious, immunologic and allergic diseases that afflict people worldwide. NIAID has a broad-based program aimed at understanding the pathogenesis of asthma and developing improved methods for preventing and treating asthma. NIAID research emphasizes the key role in the pathogenesis of the disease of certain allergens and viruses. NIAID supports a network of asthma research centers which also have a demonstration and outreach component for translation to the public. NIAID has provided long-term support for the Inner-City Asthma Study, which aims to reduce asthma morbidity among inner-city children.

Research

Natural history [Related topics: Risk factors/triggers and Genetics]

NIAID is funding a multi-center national program to study the natural history of allergy and asthma in early childhood, and the effects of exposure to cockroach, mold, house dust mite and other indoor allergens, and respiratory syncytial virus, on the course of disease. The studies are intended to develop approaches for the primary prevention of asthma (i.e., identifying individuals at high risk of developing asthma, and intervening in early childhood to prevent asthma from ever appearing). Several studies in this program are now co-funded with NIEHS.

In addition to the above program of the natural history in early childhood, the Inner-City Asthma Study (co-funded by NIEHS) supports studies on the natural history of asthma among 4-10 year old children.

Pathogenesis and Mechanisms: [Related topics: Risk factors/triggers]

A major thrust of NIAID supported research in asthma is devoted to the study of basic cellular and molecular mechanisms resulting in manifestations of asthma, including bronchoconstriction, mucus secretion, IgE antibody production, inflammation, airways hyperreactivity, and fibrosis and remodeling of lung tissue. The long-term goal of this research is to identify new targets for prevention and treatment of asthma.

Some research studies focus on the role of T lymphocytes in asthma, and investigate the differences in signaling pathways between two subsets of these cells. Other research focuses on cell surface receptors and intracellular signaling pathways in T and B lymphocytes that regulate IgE production. Other studies evaluate the functions and migration of eosinophils and other inflammatory cells that are prominent in asthmatic inflammation. Animal models, as well as combined genetic and molecular studies in animals, are contributing to studies of asthma pathogenesis.

Genetics

In addition to the genome-wide search for asthma-related genes described by NHLBI, NIAID supports a program to identify candidate genes associated with allergy and asthma, and to search for linkages of homologous candidate genes in mouse models of allergy and asthma. This program was the first to identify a linkage of high IgE levels (i.e., high allergic response) to a region of human chromosome 5, near genes for IL-4 and other cytokines.

Risk Factors/Triggers

Allergens, Infections, and Irritants

Many studies focus on allergens relevant to asthma, since IgE antibodies to certain indoor allergens (cockroach, house dust mite, dog and cat, other) increase the risk of asthma exacerbation, and preliminary data indicate that exposure to these allergens in early childhood may induce the onset of asthma. Both molecular and cellular approaches are used to identify regions of the allergen molecule that are critical to T and B cell recognition. Control of the effects of allergens is critical to asthma management. While one approach is to reduce environmental exposure, another approach is to develop vaccines or other reagents which prevent patients from making IgE antibodies to the allergens.

A substantial portion of this NIAID- supported research program is within a network of 12 extramural, and 1 intramural, Asthma, Allergic and Immunologic Diseases Cooperative Research Centers. Three of these Centers have their primary focus on environmental aspects of asthma and allergy, including the role of indoor allergens; two are co-funded by NIEHS. One of these is studying the mechanisms whereby polyaromatic hydrocarbons from diesel exhaust particulates induce IgE responses and act synergistically with inhaled allergen in stimulating immune responses. The second Center is studying the role of indoor allergens and respiratory syncytial virus (RSV) in inducing asthma in children, and determining methods of altering the responses to allergen by combinations of reduced exposure and reduced immune responses. A third Center studies the role of viruses, in conjunction with allergens, in both human and rodent models of asthma.

Risk Factors/Triggers

Infections

NHLBI and NIAID have funded a program on the role in respiratory infections in the development of childhood asthma. The NIAID-funded portion of this program investigates the epidemiology and genetic susceptibility to asthma in relation to early respiratory syncytial virus (RSV) infections, the molecular basis of immune responses induced by RSV and rhinoviruses, and the effects of viral infections on modifying the balance between allergen sensitization versus tolerance.

NIAID also supports a related program, on the mechanisms by which viruses induce inflammation and exacerbate asthma. RSV infection in young children, and rhinovirus infection in older children and adults, induce exacerbations of asthma. The interactions of viruses with epithelial cells, endothelial cells, and inflammatory cells, and the induction of cytokines and adhesion molecules, as well as synergistic actions of viruses and allergens, are of particular interest.

Asthma Management [Related Topics: Community-based partnerships and outreach]

Environmental Control, Allergens, Irritants, Strategies for secondary prevention

NIAID supports a network of 7 Cooperative Inner City Asthma Centers and a Data Coordinating Center. This program, now co-funded by NIEHS, represents an effort begun in 1991, to reduce asthma morbidity in populations which have disproportionately high asthma morbidity: namely, inner-city, predominantly African-American and Hispanic, children. The present study is testing effects on asthma morbidity of two interventions. The first is a comprehensive environmental intervention, to reduce levels of indoor allergens such as cockroach, house dust mite and mold. The second is a physician education intervention, to improve medical care via providing regular feedback on the clinical and laboratory status of children under the care of community primary care physicians. In collaboration with the U.S. Environmental Protection Agency, the Inner City Asthma Study is now evaluating the effects of indoor and outdoor pollutants on asthma morbidity.

The objective of this cooperative study is to develop, implement, and evaluate a culturally-appropriate, comprehensive, and cost-effective intervention program aimed at reducing asthma morbidity by modifying those potentially reversible factors, such as allergens and environmental tobacco smoke shown to contribute to asthma morbidity. The core protocol includes all of the following elements: medical treatment for asthma delivered in a health care facility, self-management by asthmatics and their families, and indoor environmental interventions including studies to measure, monitor, and improve indoor allergens and environmental tobacco smoke exposure.

Asthma Management/ Education and Outreach

NIAID supports a Demonstration and Education Research Program targeted toward medically under-served, predominantly inner city Hispanic and African-American populations. Many of the components of this program are funded as part of the Asthma, Allergic and Immunologic Diseases Cooperative Research Centers. This Demonstration and Education Research Program includes a multi-center study to test the effectiveness of dust mite allergen avoidance on asthma severity. The program also funds school-based studies to identify children with asthma and to use combinations of environmental control (to avoid allergens) and school-based asthma counselors to reduce asthma severity. Related studies include the identification of, and thus early intervention in very young children with asthma in a Head Start program. For example, one study utilizes nurse home visitors for self-management training and environmental intervention in high risk infants with wheezing; another study has developed a unique computer-based medical and self-management training program for families of children with asthma.

Public Health Practice

The aforementioned network of Research Centers (see Natural history and Risk factors/ Triggers) has public health efforts as well as research. Each center includes a Demonstration and Education outreach research project to test interventions for asthma in underserved populations; all but one asthma project focus on children.

National Institute of Child Health and Human Development -- Center for Research for Mothers and Children

NICHD seeks to assure that every individual is born healthy, is born wanted, and has the opportunity to fulfill his or her potential for a healthy and productive life unhampered by disease or disability. In pursuit of this mission, the NICHD conducts and supports laboratory, clinical, and epidemiological research on the reproductive, neurobiologic, developmental, and behavioral processes that determine and maintain the health of children, adults, families, and populations. The Institute conducts research on asthma in pregnant women, in infants and in children.

Research

Natural History of the Disease

NICHD's asthma research program is divided into two project areas: asthma in pregnancy and asthma in infants (less than 2 years of age). Because of the diverse nature of the projects, they are described separately below.

The first project, co-sponsored by NHLBI, is a prospective cohort study of the effects of asthma during pregnancy and treatment regimens on perinatal outcome. The objective of this study is to compare the frequency of very premature births among moderate and severe pregnant asthmatics with that of normal controls, to track asthma severity with regard to maternal morbidity and neonatal outcome, and to investigate the effects of degree of asthma control and medications with other demographic and social factors on differences on perinatal outcome. Outcome measures include small for gestational age, low birth weight, perinatal morbidity and mortality, and preterm delivery rate less than 37 weeks.

Asthma Management -- Pharmacotherapy

The second project, co-sponsored by NHLBI involves a randomized clinical trial of theophylline versus inhaled beclomethasone. The objective of this study is to determine if prolonged anti-inflammatory therapy with inhaled corticosteroids will result in better control of moderate asthma in pregnancy as compared to control with a non-anti-inflammatory drug (theophylline). Another research effort involves the NICHD Pediatric Pharmacology Research Network's evaluation of medications which are frequently used in pharmacotherapy of asthma in infants and children. This network offers an opportunity to evaluate both old therapies, as well as new chemical entities, which are being introduced by the pharmaceutical industry without any evaluation in infants and children. The network is already undertaking a study of albuterol (medication used for immediate relief of asthma symptoms) in infants and children under two years of age.

National Institute of Environmental Health Sciences

Human health and human disease result from three interactive elements: environmental factors, individual susceptibility and age. The mission of NIEHS is to reduce the burden of human illness and dysfunction from environmental causes by understanding each of these elements and how they interrelate. Highlighted activities which are co-sponsored by NIEHS include the Environmental Genome Project, the National Allergen Survey, and the Inner-City Asthma Study.

Research

Pathogenesis and Mechanisms (also Natural History of the Disease)

Poor air quality and aeroallergens can cause airway inflammation and are known risk factors for asthma development, morbidity and mortality. Developing insights into the fundamental cellular and molecular mechanisms of the respiratory system and understanding how environmental agents perturb this complex system is critical in designing effective and novel strategies for disease prevention and intervention.

NIEHS's pulmonary pathobiology research encompasses four areas: airway cell biology, inflammation, mechanisms of toxicity of pollutants, and translational research/clinical studies. This research is intended to lead to the prevention of, or intervention in, the environmental components of airway diseases, especially asthma. Research at all levels is targeted towards prevention and intervention and other translational activities. Examples include large-scale population-based studies which define risks and consequences; mechanism-based studies which use sophisticated molecular biological approaches to examine disease pathogenesis; and genetic studies which seek to identify populations that are particularly susceptible to certain environmental factors, is targeted towards prevention and intervention and other translational activities.

Genetics [Related topic: Risk factors/triggers]

NIEHS is expanding its research program on genetic susceptibility to environmentally- associated diseases through the new Environmental Genome Project initiative. This project, which will make use of technology developed by the NIH Human Genome Project, is aimed at: identifying allelic variants (polymorphisms) of environmental disease susceptibility genes in the U.S. population, developing a central database of polymorphisms for these genes, and fostering population-based studies of gene-environment interaction in disease etiology.

The NIEHS Environmental Genome Project is a multi-disciplinary, collaborative effort, involving several other NIH institutes as well as the Department of Energy (DOE) and other federal agencies. Environmental response genes that will be included in the Environmental Genome Project include, among many others, genes that mediate the immune and inflammatory responses such as those involved in asthma.

An example of this type of research is an epidemiologic study being conducted at NIEHS. DNA has been collected from children in 12 communities in Southern California to evaluate the relationship between asthma and exposure to ozone, particulate matter, acid aerosols, and nitrogen oxides. An examination of genes that may be involved in susceptibility to the respiratory effects of ozone will be conducted. Similar research by the same investigators is proposed for populations in China and Mexico.

Given the disturbingly high morbidity and mortality data from asthma seen in African-Americans and certain Hispanic populations, a genetic predisposition for asthma in these groups is a viable theory. Asthma will certainly be a disease of major interest to the Environmental Genome Project.

Risk Factors [Related topic: Natural History of the Disease]

Triggers

Although existing, smaller allergen studies have provided important data on the relationship between allergens and disease in selected groups, they have not permitted estimates of allergen exposure in the population, addressed the magnitude of allergen problems, or evaluated demographic characteristics with regard to allergen exposure. In response to these data gaps, NIEHS has joined with the Department of Housing and Urban Development (HUD) to conduct the first National Allergen Survey. The major objective of this program is to conduct a descriptive study of allergen types and levels in floor and bedding dust in the nation's housing to provide estimates of allergen exposure in the U.S. population. The secondary objective is to collect relevant data on housing conditions, demographic factors, and climate, in order to facilitate evaluation of regional, ethnic, socioeconomic, and housing characteristics and their relationship to allergen types and levels.

NIAID is funding grants, one of which is co-funded by NIEHS, on the natural history of allergy and asthma in early childhood, and the effect on the course of disease of exposure to allergens. All of these studies are intended to develop approaches for the primary prevention of asthma. More detail is provided in the "Natural History" section under NIAID's program descriptions.

Prevention

NIEHS and EPA have awarded grants to Centers that will develop multidisciplinary basic and applied research in combination with community-based prevention research projects in order to: support studies on the causes and mechanisms of children's disorders having an environmental etiology, identify relevant environmental exposures, intervene to reduce hazardous exposures and their adverse health effects, and eventually decrease the prevalence, morbidity, and mortality of environmentally related childhood diseases. One purpose of these Centers for Children's Environmental Health and Disease Prevention Research is to provide for multidisciplinary interactions among basic, clinical, and behavioral scientists interested in establishing outstanding, state-of-the-art research programs addressing environmental contributions to children's health and disease, including but not limited to asthma.

Primary Prevention

NIEHS has developed the Environmental Intervention in the Primary Prevention of Asthma in Children Study (EIPPAC) to investigate the effectiveness of persistent allergen avoidance in preventing allergen sensitization, reducing asthma prevalence, and improving lung function in high risk, lower socioeconomic status children. This interventional study will provide important information concerning the role of environmental intervention in the primary prevention of asthma in children and will provide insight into basic immunologic mechanisms operative during allergen sensitization and the expression of allergic diseases.

Secondary Prevention

NIAID and the NIEHS cooperatively fund the Inner-City Asthma Study (ICAS). Details of this study can be found under "Asthma Management/Environmental Control" in NIAID's program descriptions.

Public Health Practice

Community-Based Partnership/Outreach

The NIEHS and the Office of Behavioral and Social Sciences Research (OBSSR) have invited research grant applications addressing development of community-based strategies aimed at prevention and intervention activities in economically disadvantaged and/or underserved populations adversely impacted by an environmental contaminant. The purpose of awards in this program of Community-Based Prevention/Intervention Research in Environmental Health Sciences is to: 1) stimulate further advances in the design and implementation of prevention and intervention methods that are appropriately applied to environmental health, 2) develop community-based public health research approaches to diseases and health conditions--including asthma--having an environmentally related etiology and determine the impact of these methods, and 3) bridge the gaps between basic and clinical research in environmental health science as well as gaps between institutional researchers and community members.

The long-range goal of this program is to improve the knowledge and behavior of disadvantaged or underserved community members regarding prevention, detection, and treatment of environmentally related diseases and health conditions, and thereby reduce incidence and mortality rates of such diseases and conditions.

Other

The purpose of the Environmental Justice program is to strengthen NIEHS support of research aimed at achieving environmental justice for socioeconomically disadvantaged and medically underserved populations in the United States. The main objective of this initiative is to establish methods for linking members of a community, who are directly affected by adverse environmental conditions, with researchers and health care providers. This will ensure that the community: is aware of basic environmental health concepts, issues, and resources; has a role in identifying and defining problems and risks related to environmental exposures; is included in the dialogue shaping potential future research approaches to the problem; and actively participates with researchers and health care providers in developing responses and setting priorities for intervention strategies.

National Institute of Nursing Research

The NINR supports clinical and basic research to establish a scientific basis for the care of individuals across the life span--from management of patients during illness and recovery to the reduction of risks for disease and disability and the promotion of healthy lifestyles. According to its broad mandate, the Institute seeks to understand and ease the symptoms of acute and chronic illness such as asthma through interventions at various levels, and to improve the clinical settings in which care is provided.

Research

Prevention

NINR sponsors interventions emphasizing prevention at three levels. These include interventions targeting: the general population, particular high risk groups (such as children with family members who smoke), and those who already have asthma.

Asthma Management -- Education and Outreach

Inaccurate perceptions of symptom severity are believed to be a major reason for delays in asthma treatment, and contribute to morbidity and mortality. Nursing investigators are testing symptom-monitoring interventions in a clinical trial involving children with asthma and their parents. Results of the clinical trial will provide information on the relative benefits of the monitoring interventions and their effects on physiological, functional, and psychosocial factors. Relative use of the healthcare system will also be ascertained. Descriptive data will be developed concerning both parents' and children's views about monitoring and their adherence to the monitoring regimens.

Young, inner city children are disproportionately affected by asthma. Although asthma education programs either in the home or in clinics have been shown to increase families' effective management of asthma symptoms, the problem has repeatedly been one of ensuring attendance of low-income parents. Researchers are studying self-care management of asthma in African-American school-aged children. The research is aimed at verifying that better self-management practices coupled with nurse home visits will improve quality of life, reduce symptoms associated with asthma attacks, and decrease the number of medical visits.

NINR is supporting research to examine the effectiveness of computer-based asthma education for children 7 to 12 years old. Adherence to the education model, use of health care resources, health and quality of life will be examined. Using adult subjects, researchers are also testing the effectiveness of a 30-minute asthma education intervention to be provided in the context of the usual medical care appointment. .

National Library of Medicine

The National Library of Medicine (NLM), on the campus of the National Institutes of Health in Bethesda, Maryland, is the world's largest medical library. The Library collects materials in all areas of biomedicine and health care, as well as works on biomedical aspects of technology, the humanities, and the physical life, and social sciences. The collections stand at 5.3 million items-books, journals, technical reports, manuscripts, microfilms, photographs, and images. Housed within the Library is one of the world's finest medical history collections of old and rare medical texts and manuscripts. The Library's collections may be consulted in the reading room or requested on interlibrary loan. NLM is a national resource for all U.S. health science libraries through a National Network of Libraries of Medicine.

Public Health Practice

Public Education

The National Library of Medicine, in collaboration with the National Heart, Lung, and Blood Institute (NHLBI), the National Institute of Allergy and Infectious Diseases (NIAID), and the National Institute of Environmental Health Services (NIEHS) developed an exhibition that highlights the history of asthma, the experiences of people with asthma, and contemporary research and management efforts to control the disease. The exhibit, entitled "Breath of Life," opened with a gala reception in the rotunda of the National Library of Medicine on the grounds of the National Institutes of Health in Bethesda, MD on March 22, 1999 and runs through May, 2000. Following the exhibit's debut in the nation's capital, it will travel to cities throughout the United States and Europe carrying its message to the public in a variety of forums, via the Internet, in museums, and in places where the public gather. In addition, the Institutes are developing a broad range of supplemental programs to expand "Breath of Life's" outreach to the public about how to prevent, identify, and treat asthma.

OPHS serves as the focal point for leadership and coordination across the Department in public health and science; provides direction to program offices within OPHS; and provides advice and counsel on public health and science issues to the Secretary.

Office of Minority Health

The Office of Minority Health (OMH) was established by DHHS in 1985. It advises the Secretary and the Office of Public Health and Science on public health program activities affecting American Indian and Alaska Native, African American, Asian American and Pacific Islander, and Hispanic populations. Its goal is to promote improved health among these racial and ethnic minority populations.

Public Health Practice

Community-Based Partnership/Outreach & Family/Patient Education

Disparities in the impacts of asthma are striking among different ethnic populations. For example, rates of death and hospitalizations due to asthma are significantly higher in African Americans than in whites. The purpose of the Office of Minority Health Asthma Attack Avoidance Education Program is to establish a community-based, parent-child focused program designed to increase identification of potential asthma attack-triggering factors among minority urban children, and to ensure appropriate referral for medical care.

Office of Women's Health

The mission of the Office of Women's Health (OWH) is to improve the health of women across the life-span by directing, developing, stimulating, and coordinating women's health research, health care services, and public and health professional education and training across the agencies and offices of the DHHS; and with other government agencies, public and private organizations, and consumer and health care professional groups. The Office also advises the Secretary and Assistant Secretary for Health of DHHS on the scientific, medical, ethical and policy issues related to the advancement of women's health in the United States and internationally.

Research

While asthma prevalence has been a very immediate issue for all populations, there are certain populations which are particularly affected by the disease. Among these special concerns is women. Many reports have agreed that while males are treated for asthma more than twice as much as females up to the age of 10, after this age, the trend reverses. In addition, several issues concerning women--such as pregnancy, differences in hormones, and intake of aspirin and other antinflammatory drugs--serve as complicating factors for their asthma. Another concern is adult onset of asthma, especially in women at the start of menopause.

OWH coordinates, collaborates, develops partnerships, convenes appropriate people to address issues related to women's health. OWH often focuses on diseases for which severity, incidence, diagnosis, and treatment may be different because of gender and tries to ensure that those differences are not glossed over in the approaches being used by health care practitioners, researchers, patients, etc. OWH also helps sponsor academic centers for excellence in women's health. There are many women-centered issues which are of particular concern to people with asthma. While widespread and increasing across age groups and gender lines, the disease is becoming a growing concern in the specific field of women's health.

Region I

In Region I (Boston), DHHS and the public health commissioners from the six New England states are collaborating with the region's major managed care organizations to address asthma. Also, the Environmental Protection Agency (EPA), DHHS and the Department of Housing and Urban Development (HUD) are convening a summit meeting of federal and state environment, public health and housing officials to develop a joint strategy to help reduce the burden of asthma in New England.

Region II

Region II has developed a multi-faceted asthma initiative with components of technical assistance/consultation, grant support, and inter-departmental collaboration. The Regional Office has worked with New York City Department of Health in their implementation of a broad based community initiative with clinical, school, and home based modules. It has also awarded grants to the New York and New Jersey State Health Departments to develop community based partnerships. DHHS, the Environmental Protection Agency, and the Department of Housing and Urban Development have begun to shape coordinated asthma initiatives under the Region II Federal Regional Council. The agencies are compiling a data base and identifying geographic areas within the region exhibiting high incidence rates of asthma.

The Clinical Directors Network of Region II in collaboration with EPA and HRSA is conducting an evaluation of home environmental and medical interventions in four HRSA-funded community health centers serving minority and low-income areas. The project will measure outcomes from both interventions in 200 children.

Region III

In Region III (Philadelphia), DHHS and EPA officials are working with state and local agencies and organizations to coordinate activities and develop a strategic plan for addressing asthma in the mid-Atlantic states.

Region V

For the first time, Illinois has the highest rate of African Americans who die of asthma in the U.S., according to CDC data released in April, 1998. To address this problem, DHHS is working with EPA, the Chicago Asthma Consortium and several public, private and community organizations to develop a community-based project to reduce the morbidity and mortality due to asthma in the Chicago area. This project involves the community as a co-researcher and the professional as a co-learner. The definition of community-based for the purposes of this project are that community members are involved in laying the ground work, the design, review, implementation and interpretation of the results. This model for participatory/action research draws on the strengths and knowledge of communities to aid in disease management and the design of systems to improve health outcomes.