Status:
COMPLETED
Exhaled Breath Condensate as a Measure of Airway Inflammation in Children With Asthma
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Asthma
Eligibility:
All Genders
5-17 years
Brief 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...
Detailed Description
The onset of asthma is often during childhood, and when the child is atopic, it is more likely to persist into adulthood. Diseases such as asthma have a higher prevalence in childhood; and management ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 18 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 19 2010
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT00078208
Start Date
February 18 2004
End Date
August 19 2010
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892