AsthmaNCT00078208
Exhaled Breath Condensate as a Measure of Airway Inflammation in Children With Asthma
An observational study of Asthma, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Asthma
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2004to 19 Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Show all 14Show fewer
- 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).
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Exhaled Breath Condensate as a Measurement of Airway Inflammation in Children With Asthma
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.
Read more
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.
Read the 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 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.
- Conditions
- Asthma
- Keywords
- Pediatric, Non-Invasive, Anti-Inflammatory, pH, Mediators, Asthma, Childhood Asthma, Healthy Volunteer, HV
- Medical subject headings
- Asthma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2004 (estimated)
- Study start18 Feb 2004
- Study completion19 Aug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00078208
- Sponsor's protocol ID
- 040126
- Other IDs
- 04-I-0126
- Status last verified
- 19 Aug 2010
- First submitted
- 19 Feb 2004
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Smith DH, Malone DC, Lawson KA, Okamoto LJ, Battista C, Saunders WB. A national estimate of the economic costs of asthma. Am J Respir Crit Care Med. 1997 Sep;156(3 Pt 1):787-93. doi: 10.1164/ajrccm.156.3.9611072.
PubMed 9309994Newacheck PW, Taylor WR. Childhood chronic illness: prevalence, severity, and impact. Am J Public Health. 1992 Mar;82(3):364-71. doi: 10.2105/ajph.82.3.364.
PubMed 1536351Halfon N, Newacheck PW. Childhood asthma and poverty: differential impacts and utilization of health services. Pediatrics. 1993 Jan;91(1):56-61.
PubMed 8416505
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exhaled Breath Condensate as a Measurement of Airway Inflammation in Children With Asthma
- ClinicalTrials.gov ID
- NCT00078208
- Acronym / sponsor ID
- 040126
- Conditions
- Asthma
- Keywords
- Pediatric, Non-Invasive, Anti-Inflammatory, pH, Mediators, Asthma, Childhood Asthma, Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 18 Feb 2004
- Study completion
- 19 Aug 2010
- First posted
- 20 Feb 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 9309994Smith DH, Malone DC, Lawson KA, Okamoto LJ, Battista C, Saunders WB. A national estimate of the economic costs of asthma. Am J Respir Crit Care Med. 1997 Sep;156(3 Pt 1):787-93. doi: 10.1164/ajrccm.156.3.9611072.
- Background: PubMed 1536351Newacheck PW, Taylor WR. Childhood chronic illness: prevalence, severity, and impact. Am J Public Health. 1992 Mar;82(3):364-71. doi: 10.2105/ajph.82.3.364.
- Background: PubMed 8416505Halfon N, Newacheck PW. Childhood asthma and poverty: differential impacts and utilization of health services. Pediatrics. 1993 Jan;91(1):56-61.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00078208, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.