Protocol Number: 04-I-0126

Title:

Exhaled Breath Condensate as a Measurement of Airway Inflammation in Children with Asthma

Number:

04-I-0126

Summary:

This study will evaluate the usefulness of a new procedure for evaluating asthma in children. The method measures the pH (a measure of acidity and alkalinity) of exhaled breath condensate (water vapor created by the lungs). The condensate contains products of the lungs that may be associated with lung inflammation. Investigators will determine if the pH of the exhaled breath condensate correlates well with known asthma indicators, such as number of hospitalizations, school absenteeism, use of rescue medication, and others. Test results will be compared with findings from healthy normal volunteers. No experimental treatments or medicines are used in this study. Patients who require treatment for their asthma will receive standard care with medicines approved by the Food and Drug Administration and used widely in the United States.

Children with asthma and healthy normal volunteers between 6 and 17 years of age may be eligible for this study. You must complete the study before your 18th birthday. Candidates are screened with a medical history and physical examination.

Children with asthma undergo the following tests and procedures over six clinic visits, including an initial visit and follow-up visits at 4-8 weeks, 3, 6, 9, and 12 months:

-Blood draw in children over 6 years of age. Medications are available to decrease the pain associated with blood drawing.(initial visit)

-Allergen skin testing: Drops of up to 16 allergens are placed on the arm. The skin under each drop is scratched and the area is observed for an allergic reaction. (4- 8-week follow-up visit)

-Expired nitric oxide testing: The child breathes into a balloon to collect a portion of the gases exhaled form the lungs. This test measures the amount of nitric oxide, which correlates with bronchial inflammation. (all visits)

-Exhaled breath condensate: The child breathes into a plastic tube surrounded by a cold metal sleeve for 10 to 15 minutes. The water vapor created by the lungs (the same vapor that forms when breathing outside on a cold day) is collected and the pH measured. (all visits)

-Pulmonary (lung) function test: The child blows very hard into a tube attached to a machine to measure the airflow from the child's lungs. This test measures airflow from the lungs. (all visits) The children are given small plastic device called a peak flow meter - a device used to measure lung function - to use at home. Children whose lung function is less than 80% of the predicted value for their age may be given medicine to see if their lung function improves.

-Review of the patient's symptoms, sick days, medicines or actions taken to get over the illness; review of peak flow reports; and review of action plan. (3-, 6-, 9-, and 12-month visits)

Healthy controls will have the expired nitric oxide test, exhaled breath condensate test, and pulmonary function test at each visit at the initial and over two additional visits scheduled 6 months apart.

Sponsoring Institute:

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

ASTHMA:

Children ages 5 to less than 18 years at the time he or she is expected to complete the protocol with asthma. One or more of the following criteria will qualify for inclusion:

Doctor diagnosed asthma.

Chronic cough, worse particularly at night for greater than one month

Recurrent wheezing during the past 6 months

Symptoms of difficulty breathing occurring concurrently or worsened by, exercise, infection, animals, smoke, pollen or strong emotional expression

Medical care for treatment of respiratory symptoms consistent with asthma

Reversible (greater than or equal to 12%) airflow obstruction after an inhaled short-acting beta2-agonist

HEALTHY CONTROL:

Children between the ages of 5 and less than 18 years at the time he or she is expected to complete the protocol.

Subject (asthma or healthy control) has a non-NIH physician who provides routine and emergency care. When available, permission for access of medical records and pharmacy records will be obtained for subjects with asthma.

SUBJECT WITH IMMUNODEFICIENCY:

Children between the ages of 5 and less than 18 at the time he or she is expected to complete the protocol.

Doctor diagnosed immunodeficiency (CGD, Job's, RIND)

EXCLUSION CRITERIA:

Unacceptably poor compliance, which in the opinion of the investigator, would interfere with one's ability to study or provide medical care for the subject

Any major illness or condition that, in the opinion of the principal investigator, may interfere with the subject's ability to comply with the conditions of participation in the study:

Latex allergy

Current tobacco use

URI symptoms in the 4 weeks prior to EBC collection

Any condition that, in the opinion of their primary physician, would affect your child's participation in the study

HIV negative by history

HEALTHY CONTROL:

Asthma or allergic rhinitis

Chronic pulmonary disease

URI symptoms in the 4 weeks prior to EBC collection

Chronic corticosteroid therapy (daily or every other day dosing for greater than 14 days)

Current tobacco use

HIV negative by history

History of latex allergy

PATIENTS WITH IMMUNODEFICIENCY:

Chronic or prophylactic antibiotics

Diagnosis of asthma

Must be off antibiotics for 2 days

Special Instructions:

Currently Not Provided

Keywords:

Pediatric

Non-Invasive

Anti-Inflammatory

pH

Mediators

Recruitment Keyword(s):

Asthma

Childhood Asthma

Healthy Volunteer

HV

Condition(s):

Asthma

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Allergy and Infectious Diseases

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Smith DH, et al. A national estimate of the economic costs of asthma. Am J Respir Crit Care Med. 1997 Sep;156(3 Pt 1):787-93.

Newacheck PW, Taylor WR. Childhood chronic illness: prevalence, severity, and impact. Am J Public Health. 1992 Mar;82(3):364-71.

Halfon N, Newacheck PW. Childhood asthma and poverty: differential impacts and utilization of health services. Pediatrics. 1993 Jan;91(1):56-61.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

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