Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

The levels of evidence (A-D) are defined at the end of the "Major Recommendations" field.

New Issues Presented in this Report

1. Throughout the document, emphasis has been made that chronic obstructive pulmonary disease (COPD) is characterized by chronic airflow limitation and a range of pathological changes in the lung, some significant extrapulmonary effects, and important comorbidities that may contribute to the severity of the disease in individual patients.
2. In the definition of COPD, the phrase "preventable and treatable" has been incorporated following the American Thoracic Society/European Respiratory Society (ATS/ERS) recommendations to recognize the need to present a positive outlook for patients, to encourage the health care community to take a more active role in developing programs for COPD prevention, and to stimulate effective management programs to treat those with the disease.
3. The spirometric classification of severity of COPD now includes four stages—Stage I: Mild; Stage II: Moderate; Stage III: Severe; Stage IV: Very Severe. A fifth category - "Stage 0: At Risk," - that appeared in the 2001 report is no longer included as a stage of COPD, as there is incomplete evidence that the individuals who meet the definition of "At Risk" (chronic cough and sputum production, normal spirometry) necessarily progress on to Stage I. Nevertheless, the importance of the public health message that chronic cough and sputum are not normal is unchanged.
4. The spirometric classification of severity continues to recommend use of the fixed ratio, postbronchodilator forced expiratory volume in one second/forced vital capacity (FEV₁/FVC) <0.7, to define airflow limitation. Using the fixed ratio (FEV₁/FVC) is particularly problematic in milder patients who are elderly, as the normal process of aging affects lung volumes. Postbronchodilator reference values in this population are urgently needed to avoid potential over-diagnosis.
5. Chapter 2 of the original guideline document, Burden of COPD, provides references to published data from prevalence surveys carried out in a number of countries, using standardized methods and including spirometry, to estimate that about 15% to 25% of adults aged 40 years and older may have airflow limitation classified as Stage I: Mild COPD or higher. Evidence is also provided that the prevalence of COPD (Stage I: Mild COPD and higher) is appreciably higher in smokers and ex-smokers than in nonsmokers, in those over 40 years than those under 40, and higher in men than in women. The chapter also provides new data on COPD morbidity and mortality.
6. Throughout it is emphasized that cigarette smoke is the most commonly encountered risk factor for COPD and elimination of this risk factor is an important step toward prevention and control of COPD. However, other risk factors for COPD should be taken into account where possible. These include occupational dusts and chemicals, and indoor air pollution from biomass cooking and heating in poorly ventilated dwellings—the latter especially among women in developing countries.
7. Chapter 4 of the original guideline document, Pathology, Pathogenesis, and Pathophysiology, continues with the theme that inhaled cigarette smoke and other noxious particles cause lung inflammation, a normal response which appears to be amplified in patients who develop COPD. The chapter has been considerably updated and revised.
8. Management of COPD continues to be presented in four components: (1) Assess and Monitor Disease; (2) Reduce Risk Factors; (3) Manage Stable COPD; (4) Manage Exacerbations. All components have been updated based on recently published literature. Throughout the document, it is emphasized that the overall approach to managing stable COPD should be individualized to address symptoms and improve quality of life.
9. In Component 4 of the original guideline document, Manage Exacerbations, a COPD exacerbation is defined as: an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough, and/or sputum that is beyond normal day-to-day variations, is acute in onset, and may warrant a change in regular medication in a patient with underlying COPD.
10. It is widely recognized that a wide spectrum of health care providers are required to assure that COPD is diagnosed accurately, and that individuals who have COPD are treated effectively. The identification of effective health care teams will depend on the local health care system, and much work remains to identify how best to build these health care teams. A chapter on COPD implementation programs and issues for clinical practice has been included but it remains a field that requires considerable attention.

Definition

Spirometric Classification of Severity

For educational reasons, a simple spirometric classification of disease severity into four stages is recommended.

Note: FEV1: forced expiratory volume in one second; FVC: forced vital capacity; respiratory failure: arterial partial pressure of oxygen (PaO₂) less than 8.0 kPa (60 mm Hg) with or without arterial partial pressure of CO₂ (PaCO₂) greater than 6.7 kPa (50 mm Hg) while breathing air at sea level.

Management of COPD

Component 1: Assess and Monitor Disease

Key Points

• A clinical diagnosis of COPD should be considered in any patient who has dyspnea, chronic cough or sputum production, and/or a history of exposure to risk factors for the disease. The diagnosis should be confirmed by spirometry.
• For the diagnosis and assessment of COPD, spirometry is the gold standard as it is the most reproducible, standardized, and objective way of measuring airflow limitation. The presence of a postbronchodilator FEV₁/FVC <0.70 and FEV₁ <80% predicted confirms the presence of airflow limitation that is not fully reversible.
• Health care workers involved in the diagnosis and management of COPD patients should have access to spirometry.
• Assessment of COPD severity is based on the patient's level of symptoms, the severity of the spirometric abnormality, and the presence of complications.
• Measurement of arterial blood gas tensions should be considered in all patients with FEV₁ <50% predicted or clinical signs suggestive of respiratory failure or right heart failure.
• COPD is usually a progressive disease and lung function can be expected to worsen over time, even with the best available care. Symptoms and objective measures of airflow limitation should be monitored to determine when to modify therapy and to identify any complications that may develop.
• Comorbidities are common in COPD and should be actively identified. Comorbidities often complicate the management of COPD, and vice versa.

Initial Diagnosis

A clinical diagnosis of COPD should be considered in any patient who has dyspnea, chronic cough or sputum production, and/or a history of exposure to risk factors for the disease. The diagnosis should be confirmed by spirometry. The presence of a postbronchodilator FEV₁/FVC <0.70 and FEV₁ <80% predicted confirms the presence of airflow limitation that is not fully reversible.

See the original guideline document for a discussion of common symptoms, including dyspnea, cough, sputum production, wheezing and chest tightness, and other features of severe disease.

Medical History

A detailed medical history of a new patient known or thought to have COPD should assess:

• Patient's exposure to risk factors, such as smoking and occupational or environmental exposures
• Past medical history, including asthma, allergy, sinusitis, or nasal polyps; respiratory infections in childhood; other respiratory diseases
• Family history of COPD or other chronic respiratory disease
• Pattern of symptom development: COPD typically develops in adult life and most patients are conscious of increased breathlessness, more frequent "winter colds," and some social restriction for a number of years before seeking medical help.
• History of exacerbations or previous hospitalizations for respiratory disorder: Patients may be aware of periodic worsening of symptoms even if these episodes have not been identified as exacerbations of COPD.
• Presence of comorbidities, such as heart disease, malignancies, osteoporosis, and musculoskeletal disorders, which may also contribute to restriction of activity.
• Appropriateness of current medical treatments: For example, beta-blockers commonly prescribed for heart disease are usually contraindicated in COPD.
• Impact of disease on patient's life, including limitation of activity, missed work and economic impact, effect on family routines, feelings of depression or anxiety
• Social and family support available to the patient
• Possibilities for reducing risk factors, especially smoking cessation

Physical Examination

Though an important part of patient care, a physical examination is rarely diagnostic in COPD. Physical signs of airflow limitation are usually not present until significant impairment of lung function has occurred and their detection has a relatively low sensitivity and specificity. A number of physical signs may be present in COPD, but their absence does not exclude the diagnosis.

Refer to the original guideline document for specific physical examination assessments.

Measurement of Airflow Limitation (Spirometry)

Spirometry should be undertaken in all patients who may have COPD. It is needed to make a confident diagnosis of COPD and to exclude other diagnoses that may present with similar symptoms. Although spirometry does not fully capture the impact of COPD on a patient's health, it remains the gold standard for diagnosing the disease and monitoring its progression. It is the best standardized, most reproducible, and most objective measurement of airflow limitation available. Good quality spirometric measurement is possible and all health care workers who care for COPD patients should have access to spirometry. Figure 5.1-4 in the original guideline document summarizes some of the factors needed to achieve accurate test results.

Spirometry should measure the volume of air forcibly exhaled from the point of maximal inspiration (forced vital capacity, FVC) and the volume of air exhaled during the first second of this maneuver (forced expiratory volume in one second, FEV₁), and the ratio of these two measurements (FEV₁/FVC) should be calculated. Spirometry measurements are evaluated by comparison with reference values based on age, height, sex, and race (use appropriate reference values).

Assessment of COPD Severity

Assessment of COPD severity is based on the patient's level of symptoms, the severity of the spirometric abnormality (see "Spirometric Classification of COPD Severity Based on Post-Bronchodilators FEV₁" above), and the presence of complications such as respiratory failure, right heart failure, weight loss, and arterial hypoxemia.

When evaluating symptomatic patients presenting to a physician, the severity of the patient's symptoms and the degree to which they affect his or her daily life, not just the severity of airflow obstruction, are the major determinants of health status. The severity of a patient's breathlessness is important and can be usefully gauged by the Medical Research Council (MRC) scale (see Figure 5.1-2 in the original guideline document).

Objectively measured exercise impairment, assessed by a reduction in self-paced walking distance or during incremental exercise testing in a laboratory, is a powerful indicator of health status impairment and predictor of prognosis. The ratio of inspiratory capacity to total lung capacity determined plethysmographically has also been found to be prognostically useful. Similarly, weight loss and reduction in the arterial oxygen tension identify patients at increased risk for mortality.

A relatively simple approach to identifying disease severity using a combination of most of the above variables has been proposed. The BODE method gives a composite score (Body mass index, Obstruction, Dyspnea, and Exercise) that is a better predictor of subsequent survival than any component singly, and its properties as a measurement tool are under investigation.

Refer to the original guideline document for additional investigations that are considered.

Differential Diagnosis

In some patients with chronic asthma, a clear distinction from COPD is not possible using current imaging and physiological testing techniques, and it is assumed that asthma and COPD coexist in these patients. In these cases, current management is similar to that of asthma. Other potential diagnoses are usually easier to distinguish from COPD. Refer to Figure 5.1-7 in the original guideline document for other potential diagnoses.

Ongoing Monitoring and Assessment

Visits to health care facilities will increase in frequency as COPD progresses. The type of health care workers seen, and the frequency of visits, will depend on the health care system. Ongoing monitoring and assessment in COPD ensures that the goals of treatment are being met and should include evaluation of: (1) exposure to risk factors, especially tobacco smoke; (2) disease progression and development of complications; (3) pharmacotherapy and other medical treatment; (4) exacerbation history; (5) comorbidities.

Suggested questions for follow-up visits are listed in Figure 5.1-8 in the original guideline document. The best way to detect changes in symptoms and overall health status is to ask the patient the same questions at each visit.

Monitor Disease Progression and Development of Complications

COPD is usually a progressive disease. Lung function can be expected to worsen over time, even with the best available care. Symptoms and objective measures of airflow limitation should be monitored to determine when to modify therapy and to identify any complications that may develop. As at the initial assessment, follow-up visits should include a physical examination and discussion of symptoms, particularly any new or worsening symptoms.

Pulmonary Function

A patient's decline in lung function is best tracked by periodic spirometry measurements although useful information about lung function decline is unlikely from spirometry measurements performed more than once a year. Spirometry should be performed if there is a substantial increase in symptoms or a complication.

Other pulmonary function tests, such as flow-volume loops, diffusing capacity (D_LCO) measurements, inspiratory capacity, and measurement of lung volumes are not needed in a routine assessment but can provide information about the overall impact of the disease and can be valuable in resolving diagnostic uncertainties and assessing patients for surgery.

Refer to the original guideline document for other specific assessments of disease progression.

Monitor Pharmacotherapy and Other Medical Treatment

In order to adjust therapy appropriately as the disease progresses, each follow-up visit should include a discussion of the current therapeutic regimen. Dosages of various medications, adherence to the regimen, inhaler technique, effectiveness of the current regime at controlling symptoms, and side effects of treatment should be monitored.

Monitor Exacerbation History

During periodic assessments, health care workers should question the patient and evaluate any records of exacerbations, both self-treated and those treated by other health care providers. Frequency, severity, likely causes of exacerbations and the patient's psychological wellbeing should be evaluated. Increased sputum volume, acutely worsening dyspnea, and the presence of purulent sputum should be noted. Specific inquiry into unscheduled visits to providers, telephone calls for assistance, and use of urgent or emergency care facilities may be helpful. Severity can be estimated by the increased need for bronchodilator medication or glucocorticosteroids and by the need for antibiotic treatment. Hospitalizations should be documented, including the facility, duration of stay, and any use of critical care or intubation. The clinician then can request summaries of all care received to facilitate continuity of care.

Monitor Comorbidities

Comorbidities are common in COPD. Some may be an indirect result of COPD, arising independently but more likely to occur when COPD is present, e.g., ischemic heart disease, bronchial carcinoma, osteoporosis. Other comorbid conditions may coexist with COPD because they become prevalent as part of the aging process, e.g., arthritis, diabetes, reflux esophagitis and depression. All comorbid conditions become harder to manage when COPD is present, either because COPD adds to the total level of disability or because COPD therapy adversely affects the comorbid disorder. All comorbid conditions amplify the disability associated with COPD and can potentially complicate its management. Until more integrated guidance about disease management for specific comorbid problems becomes available, the focus should be on identification and management of these individual problems in line with local treatment guidance.

Component 2: Reduce Risk Factors

Key Points

• Reduction of total personal exposure to tobacco smoke, occupational dusts and chemicals, and indoor and outdoor air pollutants are important goals to prevent the onset and progression of COPD.
• Smoking cessation is the single most effective—and cost effective—intervention in most people to reduce the risk of developing COPD and stop its progression (Evidence A).
• Comprehensive tobacco control policies and programs with clear, consistent, and repeated nonsmoking messages should be delivered through every feasible channel.
• Efforts to reduce smoking through public health initiatives should also focus on passive smoking to minimize risks for nonsmokers.
• Many occupationally induced respiratory disorders can be reduced or controlled through a variety of strategies aimed at reducing the burden of inhaled particles and gases.
• Reducing the risk from indoor and outdoor air pollution is feasible and requires a combination of public policy and protective steps taken by individual patients.

Introduction

Identification, reduction, and control of risk factors are important steps toward prevention and treatment of any disease. In the case of COPD, these factors include tobacco smoke, occupational exposures, and indoor and outdoor air pollution and irritants. Since cigarette smoking is the most commonly encountered risk factor for COPD worldwide, tobacco control (smoking prevention) programs should be implemented and smoking cessation programs should be readily available and encouraged for all individuals who smoke. Reduction of total personal exposure to occupational dusts, fumes, and gases and to indoor and outdoor air pollutants is also an important goal to prevent the onset and progression of COPD.

Tobacco Smoke

Smoking Prevention

Comprehensive tobacco control policies and programs with clear, consistent, and repeated nonsmoking messages should be delivered through every feasible channel, including health care providers, community activities, schools, and radio, television, and print media. National and local campaigns should be undertaken to reduce exposure to tobacco smoke in public forums. Such bans are proving to be workable and to result in measurable gains in respiratory health. Legislation to establish smoke-free schools, public facilities, and work environments should be developed and implemented by government officials and public health workers, and encouraged by the public. Smoking prevention programs should target all ages, including young children, adolescents, young adults, and pregnant women. Interventions to prevent smoking uptake and maximize cessation should be implemented at every level of the health care system. Physicians and public health officials should encourage smoke-free homes.

Smoking Cessation

Smoking cessation is the single most effective—and cost effective—way to reduce exposure to COPD risk factors. Quitting smoking can prevent or delay the development of airflow limitation, or reduce its progression, and can have a substantial effect on subsequent mortality. All smokers—including those who may be at risk for COPD as well as those who already have the disease—should be offered the most intensive smoking cessation intervention feasible.

The Role of Health Care Providers in Smoking Cessation

A successful smoking cessation strategy requires a multifaceted approach, including public policy, information dissemination programs, and health education through the media and schools. However, health care providers, including physicians, nurses, dentists, psychologists, pharmacists, and others, are key to the delivery of smoking cessation messages and interventions. Involving as many of these individuals as possible will help. Health care workers should encourage all patients who smoke to quit, even those patients who come to the health care provider for unrelated reasons and do not have symptoms of COPD, evidence of airflow limitation, or other smoking-related disease. Guidelines for smoking cessation entitled Treating Tobacco Use and Dependence: A Clinical Practice Guideline were published by the US Public Health Service. The major conclusions are summarized in Figure 5.2-2 in the original guideline document. See also Figure 5.2-3 in the original guideline document fort brief strategies to help the patient willing to quit.

Counseling

Counseling delivered by physicians and other health professionals significantly increases quit rates over self-initiated strategies. Even a brief (3-minute) period of counseling to urge a smoker to quit results in smoking cessation rates of 5-10%. At the very least, this should be done for every smoker at every health care provider visit. Education in how to offer optimal smoking cessation advice and support should be a mandatory element of curricula for health professionals.

Both individual and group counseling are effective formats for smoking cessation programs. Several particular items of counseling content seem to be especially effective, including problem solving, general skills training, and provision of intra-treatment support. The common subjects covered in successful problem solving/skills training programs include:

• Recognition of danger signals likely to be associated with the risk of relapse, such as being around other smokers, psychosocial stress, being under time pressure, getting into an argument, drinking alcohol, and negative moods
• Enhancement of skills needed to handle these situations, such as learning to anticipate and manage or avoid a particular stress
• Basic information about smoking and successful quitting, such as the nature and time course of withdrawal, the addictive nature of smoking, and the fact that any return to smoking, including even a single puff, increases the likelihood of a relapse

Systematic programs to sustain smoking cessation should be implemented in health care settings.

Pharmacotherapy

Numerous effective pharmacotherapies for smoking cessation now exist, and pharmacotherapy is recommended when counseling is not sufficient to help patients quit smoking. Special consideration should be given before using pharmacotherapy in selected populations: people with medical contraindications, light smokers (fewer than 10 cigarettes/day), and pregnant and adolescent smokers.

Refer to the original guideline document for information on nicotine replacement products and other pharmacotherapies.

Occupational Exposures

Although it is not known how many individuals are at risk of developing respiratory disease from occupational exposures in either developing or developed countries, many occupationally induced respiratory disorders can be reduced or controlled through a variety of strategies aimed at reducing the burden of inhaled particles and gases:

• Implement, monitor, and enforce strict, legally mandated control of airborne exposure in the workplace.
• Initiate intensive and continuing education of exposed workers, industrial managers, health care workers, primary care physicians, and legislators.
• Educate employers, workers, and policymakers on how cigarette smoking aggravates occupational lung diseases and why efforts to reduce smoking where a hazard exists are important.

The main emphasis should be on primary prevention, which is best achieved by the elimination or reduction of exposures to various substances in the workplace. Secondary prevention, achieved through surveillance and early case detection, is also of great importance. Both approaches are necessary to improve the present situation and to reduce the burden of lung disease. Although studies as yet have not been done to demonstrate reduced burden of disease, it is the logical consequence of effective strategies to reduce workplace exposure to respiratory irritants and toxic inhalants.

Indoor and Outdoor Air Pollution

Individuals experience diverse indoor and outdoor environments throughout the day, each of which has its own unique set of air contaminants and particulates that cause adverse effects on lung function.

Although outdoor and indoor air pollution are generally considered separately, the concept of total personal exposure may be more relevant for COPD. Reducing the risk from indoor and outdoor air pollution is feasible and requires a combination of public policy and protective steps taken by individual patients. Reduction of exposure to smoke from biomass fuel, particularly among women and children, is a crucial goal to reduce the prevalence of COPD worldwide. Although efficient non-polluting cooking stoves have been developed, their adoption has been slow due to social customs and cost.

Regulation of Air Quality

At the national level, achieving a set level of air quality standards should be a high priority; this goal will normally require legislative action. Details on setting and maintaining air quality goals are beyond the scope of this document, but public policy to reduce vehicle and industrial emissions to safe levels is an urgent priority to reduce the development of COPD as well as symptoms, exacerbations, and hospital admissions in those with disease. Understanding health risks posed by local air pollution sources may be difficult and requires skills in community health, toxicology, and epidemiology. Local physicians may become involved through concerns about the health of their patients or as advocates for the community's environment.

Steps for Health Care Providers/Patients

The health care provider should consider COPD risk factors including smoking history, family history, exposure to indoor/outdoor pollution) and socioeconomic status for each individual patient. Some steps to consider:

Individuals at Risk for COPD:

• Patients should be counseled concerning the nature and degree of their risk for COPD.
• If various solid fuels are used for cooking and heating, adequate ventilation should be encouraged.
• Respiratory protective equipment has been developed for use in the workplace in order to minimize exposure to toxic gases and particles. Under most circumstances, vigorous attempts should be made to reduce exposure through reducing workplace emissions and improving ventilation measures, rather than simply by using respiratory protection to reduce the risks of ambient air pollution.
• Ventilation and interventions to meet safe air quality standards in the workplace offer the greatest opportunity to reduce worker exposure to known atmospheric pollutants and reduce the risk of developing COPD, although to date there are no studies to quantify these benefits.

Patients Who Have Been Diagnosed with COPD:

• Persons with advanced COPD should monitor public announcements of air quality and be aware that staying indoors when air quality is poor may help reduce their symptoms.
• The use of medication should follow the usual clinical indications; therapeutic regimens should not be adjusted because of the occurrence of a pollution episode without evidence of worsening of symptoms or lung function.
• Those who are at high risk should avoid vigorous exercise outdoors during pollution episodes.
• Air cleaners have not been shown to have health benefits, whether directed at pollutants generated by indoor sources or at those brought in with outdoor air.

Component 3: Manage Stable COPD

Key Points

• The overall approach to managing stable COPD should be individualized to address symptoms and improve quality of life.
• For patients with COPD, health education plays an important role in smoking cessation (Evidence A) and can also play a role in improving skills, ability to cope with illness and health status.
• None of the existing medications for COPD have been shown to modify the long-term decline in lung function that is the hallmark of this disease (Evidence A). Therefore, pharmacotherapy for COPD is used to decrease symptoms and/or complications.
• Bronchodilator medications are central to the symptomatic management of COPD (Evidence A). They are given on an as-needed basis or on a regular basis to prevent or reduce symptoms and exacerbations.
• The principal bronchodilator treatments are beta₂-agonists, anticholinergics, and methylxanthines used singly or in combination (Evidence A).
• Regular treatment with long-acting bronchodilators is more effective and convenient than treatment with short-acting bronchodilators (Evidence A).
• The addition of regular treatment with inhaled glucocorticosteroids to bronchodilator treatment is appropriate for symptomatic COPD patients with an FEV₁ <50% predicted (Stage III: Severe COPD and Stage IV: Very Severe COPD) and repeated exacerbations (Evidence A).
• Chronic treatment with systemic glucocorticosteroids should be avoided because of an unfavorable benefit-to-risk ratio (Evidence A).
• In COPD patients influenza vaccines can reduce serious illness (Evidence A). Pneumococcal polysaccharide vaccine is recommended for COPD patients 65 years and older and for COPD patients younger than age 65 with an FEV₁ <40% predicted (Evidence B).
• All COPD patients benefit from exercise training programs, improving with respect to both exercise tolerance and symptoms of dyspnea and fatigue (Evidence A).
• The long-term administration of oxygen (>15 hours per day) to patients with chronic respiratory failure has been shown to increase survival (Evidence A).

Introduction

The overall approach to managing stable COPD should be characterized by an increase in treatment, depending on the severity of the disease and the clinical status of the patient. The step-down approach used in the chronic treatment of asthma is not applicable to COPD since COPD is usually stable and very often progressive. Management of COPD involves several objectives (see Chapter 5, Introduction, in the original guideline document) that should be met with minimal side effects from treatment. It is based on an individualized assessment of disease severity and response to various therapies. Refer to Figure 5.3-1 in the original guideline document for factors that affect the severity of COPD.

The classification of severity of stable COPD incorporates an individualized assessment of disease severity and therapeutic response into the management strategy. The severity of airflow limitation (see Figure 1-2 in the original guideline document) provides a general guide to the use of some treatments, but the selection of therapy is predominantly determined by the patient's symptoms and clinical presentation. Treatment also depends on the patient's educational level and willingness to apply the recommended management, on cultural and local conditions, and on the availability of medications.

Education

Although patient education is generally regarded as an essential component of care for any chronic disease, the role of education in COPD has been poorly studied. Assessment of the value of education in COPD may be difficult because of the relatively long time required to achieve improvements in objective measurements of lung function.

Ideally, educational messages should be incorporated into all aspects of care for COPD and may take place in many settings: consultations with physicians or other health care workers, home-care or outreach programs, and comprehensive pulmonary rehabilitation programs.

Goals and Educational Strategies

It is vital for patients with COPD to understand the nature of their disease, risk factors for progression, and their role and the role of health care workers in achieving optimal management and health outcomes. Education should be tailored to the needs and environment of the individual patient, interactive, directed at improving quality of life, simple to follow, practical, and appropriate to the intellectual and social skills of the patient and the caregivers.

In managing COPD, open communication between patient and physician is essential. In addition to being empathic, attentive and communicative, health professionals should pay attention to patients' fears and apprehensions, focus on educational goals, tailor treatment regimens to each individual patient, anticipate the effect of functional decline, and optimize patients' practical skills.

Several specific education strategies have been shown to improve patient adherence to medication and management regimens. In COPD, adherence does not simply refer to whether patients take their medication appropriately. It also covers a range of nonpharmacologic treatments, e.g., maintaining an exercise program after pulmonary rehabilitation, undertaking and sustaining smoking cessation, and using devices such as nebulizers, spacers, and oxygen concentrators properly.

Components of an Education Program

The topics that seem most appropriate for an education program include smoking cessation; basic information about COPD and pathophysiology of the disease; general approach to therapy and specific aspects of medical treatment; self-management skills; strategies to help minimize dyspnea; advice about when to seek help; self-management and decision-making during exacerbations; and advance directives and end-of-life issues (See Table below). Education should be part of consultations with health care workers beginning at the time of first assessment for COPD and continuing with each follow-up visit. The intensity and content of these educational messages should vary depending on the severity of the patient's disease. In practice, a patient often poses a series of questions to the physician (see Figure 5.3-3 in the original guideline document). It is important to answer these questions fully and clearly, as this may help make treatment more effective.

There are several different types of educational programs, ranging from simple distribution of printed materials, to teaching sessions designed to convey information about COPD, to workshops designed to train patients in specific skills. Self-management programs for COPD patients are being developed and medical/economic benefits evaluated. Limited published data exist evaluating the efficacy of chronic care model components in COPD management. However, COPD patients recruited to a comprehensive COPD education program in Canada had significantly fewer exacerbations and hospitalizations and used fewer health care resources. These encouraging results require replication in other health care systems and patient groups.

Although printed materials may be a useful adjunct to other educational messages, passive dissemination of printed materials alone does not improve skills or health outcomes. Education is most effective when it is interactive and conducted in small workshops (Evidence B) designed to improve both knowledge and skills. Behavioral approaches such as cognitive therapy and behavior modification lead to more effective self-management skills and maintenance of exercise programs.

Pharmacologic Treatment

Overview of the Medications

Pharmacologic therapy is used to prevent and control symptoms, reduce the frequency and severity of exacerbations, improve health status, and improve exercise tolerance. None of the existing medications for COPD have been shown to modify the long-term decline in lung function that is the hallmark of this disease (Evidence A). However, this should not preclude efforts to use medications to control symptoms. Since COPD is usually progressive, recommendations for the pharmacological treatment of COPD reflect the following general principles:

• Treatment tends to be cumulative with more medications being required as the disease state worsens.
• Regular treatment needs to be maintained at the same level for long periods of time unless significant side effects occur or the disease worsens.
• Individuals differ in their response to treatment and in the side effects they report during therapy. Careful monitoring is needed over an appropriate period to ensure that the specific aim of introducing a therapy has been met without an unacceptable cost to the patient. The effect of therapy in COPD may occur sooner after treatment with bronchodilators and inhaled glucocorticosteroids than previously thought, although at present, there is no effective way to predict whether or not treatment will reduce exacerbations.

The medications are presented in the order in which they would normally be introduced in patient care, based on the level of disease severity and clinical symptoms. However, each treatment regimen needs to be patient-specific as the relationship between the severity of symptoms and the severity of airflow limitation is influenced by other factors, such as the frequency and severity of exacerbations, the presence of one or more complications, the presence of respiratory failure, comorbidities (cardiovascular disease, sleep-related disorders, etc.), and general health status.

The classes of medications commonly used in treating COPD are shown in Figure 5.3-4 in the original guideline document. The choice within each class depends on the availability of medication and the patient's response.

Bronchodilators

Bronchodilator medications are central to the symptomatic management of COPD (Evidence A) (see Table below). They are given either on an as-needed basis for relief of persistent or worsening symptoms, or on a regular basis to prevent or reduce symptoms. The side effects of bronchodilator therapy are pharmacologically predictable and dose dependent. Adverse effects are less likely, and resolve more rapidly after treatment withdrawal, with inhaled than with oral treatment. However, COPD patients tend to be older than asthma patients and more likely to have comorbidities, so their risk of developing side effects is greater.

See the original guideline document for more information on bronchodilators, including beta₂-agonists, anticholinergics, methylxanthines, and combination bronchodilator therapy.

Glucocorticosteroids

The effects of oral and inhaled glucocorticosteroids in COPD are much less dramatic than in asthma, and their role in the management of stable COPD is limited to specific indications. The use of glucocorticosteroids for the treatment of acute exacerbations is described in the section "Component 4: Manage Exacerbations."

See the original guideline document for a discussion of the use of oral and inhaled glucocorticosteroids in the management of chronic COPD.

Pharmacologic Therapy by Disease Severity

Figure 5.3-7 in the original guideline documents provides a summary of recommended treatment at each stage of COPD. For patients with few or intermittent symptoms (Stage I: Mild COPD), use of a short-acting inhaled bronchodilator as needed to control dyspnea is sufficient. If inhaled bronchodilators are not available, regular treatment with slow-release theophylline should be considered.

In patients with Stage II: Moderate COPD to Stage IV: Very Severe COPD whose dyspnea during daily activities is not relieved despite treatment with as-needed short-acting bronchodilators, adding regular treatment with a long-acting inhaled bronchodilator is recommended (Evidence A). Regular treatment with long-acting bronchodilators is more effective and convenient than treatment with short-acting bronchodilators (Evidence A). There is insufficient evidence to favor one long-acting bronchodilator over others. For patients on regular long-acting bronchodilator therapy who need additional symptom control, adding theophylline may produce additional benefits (Evidence B).

Patients with Stage II: Moderate COPD to Stage IV: Very Severe COPD who are on regular short- or long-acting bronchodilator therapy may also use a short-acting bronchodilator as needed.

Some patients may request regular treatment with high-dose nebulized bronchodilators, especially if they have experienced subjective benefit from this treatment during an acute exacerbation. Clear scientific evidence for this approach is lacking, but one suggested option is to examine the improvement in mean daily peak expiratory flow recording during two weeks of treatment in the home and continue with nebulizer therapy if a significant change occurs. In general, nebulized therapy for a stable patient is not appropriate unless it has been shown to be better than conventional dose therapy.

In patients with a postbronchodilator FEV₁ <50% predicted (Stage III: Severe COPD to Stage IV: Very Severe COPD) and a history of repeated exacerbations (for example, 3 in the last 3 years), regular treatment with inhaled glucocorticosteroids reduces the frequency of exacerbations and improves health status. In these patients, regular treatment with an inhaled glucocorticosteroid should be added to long-acting inhaled bronchodilators. Chronic treatment with oral glucocorticosteroids should be avoided.

Refer to the original guideline document for a discussion of other pharmacologic treatments.

Non-Pharmacologic Treatment

Rehabilitation

The principal goals of pulmonary rehabilitation are to reduce symptoms, improve quality of life, and increase physical and emotional participation in everyday activities. To accomplish these goals, pulmonary rehabilitation covers a range of non-pulmonary problems that may not be adequately addressed by medical therapy for COPD. Such problems, which especially affect patients with Stage II: Moderate COPD, Stage III: Severe COPD, and Stage IV: Very Severe COPD, include exercise de-conditioning, relative social isolation, altered mood states (especially depression), muscle wasting, and weight loss. These problems have complex interrelationships and improvement in any one of these interlinked processes can interrupt the "vicious circle" in COPD so that positive gains occur in all aspects of the illness (see Figure 5.3-9 in the original guideline document). A comprehensive statement on pulmonary rehabilitation has been prepared by the American Thoracic Society/European Respiratory Society.

See Figure 5.3-10 in the original guideline document for a list of benefits of pulmonary rehabilitation in COPD.

Patient Selection and Program Design

Although more information is needed on criteria for patient selection for pulmonary rehabilitation programs, COPD patients at all stages of disease appear to benefit from exercise training programs, improving with respect to both exercise tolerance and symptoms of dyspnea and fatigue (Evidence A). Data suggest that these benefits can be sustained even after a single pulmonary rehabilitation program.

Benefit does wane after a rehabilitation program ends, but if exercise training is maintained at home, the patient's health status remains above pre-rehabilitation levels (Evidence B). To date there is no consensus on whether repeated rehabilitation courses enable patients to sustain the benefits gained through the initial course.

Ideally, pulmonary rehabilitation should involve several types of health professionals. Significant benefits can also occur with more limited personnel, as long as dedicated professionals are aware of the needs of each patient. Benefits have been reported from rehabilitation programs conducted in inpatient, outpatient, and home settings. Considerations of cost and availability most often determine the choice of setting. The educational and exercise training components of rehabilitation are usually conducted in groups, normally with 6 to 8 individuals per class (Evidence D).

Refer to the original guideline document for considerations important in choosing patients.

Components of Pulmonary Rehabilitation Programs

The components of pulmonary rehabilitation vary widely from program to program but a comprehensive pulmonary rehabilitation program includes exercise raining, nutrition counseling, and education. See the original guideline document for a discussion of these components.

Assessment and Follow-up

Baseline and outcome assessments of each participant in a pulmonary rehabilitation program should be made to quantify individual gains and target areas for improvement. Assessments should include:

• Detailed history and physical examination
• Measurement of spirometry before and after a bronchodilator drug
• Assessment of exercise capacity
• Measurement of health status and impact of breathlessness
• Assessment of inspiratory and expiratory muscle strength and lower limb strength (e.g., quadriceps) in patients who suffer from muscle wasting

The first two assessments are important for establishing entry suitability and baseline status but are not used in outcome assessment. The last three assessments are baseline and outcome measures.

Oxygen Therapy

Oxygen therapy, one of the principal nonpharmacologic treatments for patients with Stage IV: Very Severe COPD, can be administered in three ways: long-term continuous therapy, during exercise, and to relieve acute dyspnea. The primary goal of oxygen therapy is to increase the baseline PaO₂ to at least 8.0 kPa (60 mm Hg) at sea level and rest, and/or produce an SaO₂ at least 90%, which will preserve vital organ function by ensuring adequate delivery of oxygen.

The long-term administration of oxygen (>15 hours per day) to patients with chronic respiratory failure has been shown to increase survival. It can also have a beneficial impact on hemodynamics, hematologic characteristics, exercise capacity, lung mechanics, and mental state. Continuous oxygen therapy decreased resting pulmonary artery pressure in one study but not in another study. Prospective studies have shown that the primary hemodynamic effect of oxygen therapy is preventing the progression of pulmonary hypertension. Long-term oxygen therapy improves general alertness, motor speed, and hand grip, although the data are less clear about changes in quality of life and emotional state. The possibility of walking while using some oxygen devices may help to improve physical conditioning and have a beneficial influence on the psychological state of patients.

Long-term oxygen therapy is generally introduced in Stage IV: Very Severe COPD for patients who have:

• PaO₂ at or below 7.3 kPa (55 mm Hg) or SaO₂ at or below 88%, with or without hypercapnia (Evidence B); or
• PaO₂ between 7.3 kPa (55 mm Hg) and 8.0 kPa (60 mm Hg), or SaO2 of 88%, if there is evidence of pulmonary hypertension, peripheral edema suggesting congestive cardiac failure, or polycythemia (hematocrit >55%) (Evidence D).

Global Initiative for Chronic Obstructive Lung Disease (GOLD) Executive Committee (2006): A. Sonia Buist, MD (Chair) Oregon Health & Science University, Portland, Oregon, USA; Antonio Anzueto, MD (Representing the American Thoracic Society) University of Texas Health Science Center, San Antonio, Texas, USA; Peter Calverley, MD, University Hospital Aintree, Liverpool, UK; Teresita S. deGuia, MD, Philippine Heart Center, Quezon City, Philippines; Yoshinosuke Fukuchi, MD (Representing the Asian Pacific Society for Respirology) Tokyo, Japan; Christine Jenkins, MD, Woolcock Institute of Medical Research, Sydney, NSW, Australia; Nikolai Khaltaev, MD (Representing the World Health Organization) Geneva, Switzerland; James Kiley, PhD (Representing the National Heart, Lung, and Blood Institute, National Institutes of Health, Department of Health and Human Services) Bethesda, Maryland, USA; Ali Kocabas, MD, Cukurova University School of Medicine, Balcali, Adana, Turkey; Mará Victorina López, MD (Representing the Latin American Thoracic Society) Montevideo, URUGUAY; Ewa Nizankowska-Mogilnicka, MD, University School of Medicine, Krakow, Poland; Klaus F. Rabe, MD, PhD, Leiden University Medical Center, Leiden, The Netherlands; Roberto Rodriguez Roisin, MD, Hospital Clinic, Barcelona, Spain; Thys van der Molen, MD, University of Groningen, Groningen, The Netherlands; Chris van Weel, MD (Representing the World Organization of Family Doctors (WONCA)) University of Nijmegen, Nijmegen, The Netherlands

Global Initiative for Chronic Obstructive Lung Disease (GOLD) Science Committee (2006): Klaus F. Rabe, MD, PhD (Chair) Leiden University Medical Center, Leiden, The Netherlands; A. G. Agusti, MD (Effective June 2006) Hospital Universitari Son Dureta, Palma de Mallorca, Spain; Antonio Anzueto, MD, University of Texas Health Science Center, San Antonio, Texas, USA; Peter J. Barnes, MD, National Heart and Lung Institute, London, UK; A. Sonia Buist, MD, Oregon Health & Science University, Portland, Oregon, USA; Peter Calverley, MD, University Hospital Aintree, Liverpool, UK; Marc Decramer, MD (Effective June 2006) University Hospital, Leuven, Belgium; Yoshinosuke Fukuchi, MD, President, Asian Pacific Society for Respirology, Tokyo, Japan; Paul Jones, MD (Effective June 2006) St. George's Hospital Medical School, London, UK; Roberto Rodriguez Roisin, MD, Hospital Clinic, Barcelona, Spain; Jorgen Vestbo, MD (Effective June 2006) Hvidovre University Hospital, Hvidovre, Denmark; Jan Zielinski, MD, Institute of TB and Lung Diseases, Warsaw, Poland

The following summaries are available:

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