Completed

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

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What is being collected

Data Collection

Who is being recruted

Asthma+8

+ Bronchial Diseases

+ Hypersensitivity

From 5 to 17 Years
See all eligibility criteria
How is the trial designed

Observational
Study Start: February 2004
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 18, 2004

Actual date on which the first participant was enrolled.

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 that alters the morbidity of allergic disease in children may impact disease outcomes in future years. Asthma is the most prevalent chronic disease in childhood and accounts for the highest rate of hospitalizations in the ages between 0-4 years. Unfortunately, there are few noninvasive objective measurements of pulmonary health in children. Current techniques include determination of peak flow, spirometry, and measurement of nitric oxide (NO). Bronchial inflammation is a central feature of asthma and anti-inflammatory therapy is the mainstay of treatment. Expired NO (eNO) has been shown to correlate with bronchial inflammation. However, the collection of NO has only been available in research settings due to the limitations of collection and analysis. In contrast, exhaled breath condensate (EBC) is easily obtained and pH analysis technically simple. Determination of pH in EBC is a novel, non-invasive technique in clinical study as a means to evaluate the severity of pulmonary inflammation. In the protocol described, we will evaluate the utility of EBC in the measurement of airway disease in 60 children with asthma and compare them to 30 healthy cohorts in the same age range. We will determine if EBC pH is reflective of the degree of morbidity in children by correlating measurements with known parameters of disease including: 1) number of hospitalizations, 2) absenteeism from school, 3) number of asthma exacerbations, 4) loss of work days (if applicable), 5) extent of rescue medication usage, 6) spirometry to evaluate obstruction, and 7) NO as a measurement of inflammation. Subjects will be evaluated and then categorized based on the National Asthma Education and Prevention Program (NAEPP) guidelines. We will measure the pH from EBC in children age 6 to less than 18 years of age and compare findings to clinical data, spirometry, and expired NO. In this way, we will determine if EBC is a potentially useful non-invasive measurement of airway disease. It is hoped that measurements of EBC will be helpful in identifying those children in which the addition of an anti-inflammatory medication is appropriate. We will also attempt to measure inflammatory mediators to determine if they can be used to assess inflammation. This method may also be useful in detecting airway inflammation due to an infectious agent before a systemic reaction (fever, respiratory distress, or cough) is apparent in children with various immunodeficiency diseases such as chronic granulomatous disease (CGD), recurrent respiratory infections without a defined host defect (RIND), or Job's syndrome. We will recruit 30 healthy control children in the same age range to compare the EBC pH values in children without allergic or other chronic pulmonary diseases. In addition, we will recruit 30 children (10 in each group) with CGD, RIND, and Job's to compare exhaled breath condensate pH and exhaled nitric oxide values to those from children with allergic airway inflammation to determine if these methods are useful for early diagnosis of infectious airway inflammation.

Official TitleExhaled Breath Condensate as a Measurement of Airway Inflammation in Children With Asthma 
NCT00078208
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

128 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 5 to 17 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AsthmaBronchial DiseasesHypersensitivityHypersensitivity, ImmediateImmune System DiseasesInflammationLung DiseasesLung Diseases, ObstructivePathologic ProcessesRespiratory HypersensitivityRespiratory Tract Diseases

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, United StatesSee the location
CompletedOne Study Center