Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00078208
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2004-02-19
Brief Title:
Exhaled Breath Condensate as a Measure of Airway Inflammation in Children With Asthma
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Exhaled Breath Condensate as a Measurement of Airway Inflammation in Children With Asthma
Status:
COMPLETED
Status Verified Date:
2010-08-19
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 drawinginitial 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 childs 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 patients 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
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 drawinginitial 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 childs 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 patients 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 Jobs 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 Jobs 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
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 Jobs 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 Jobs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-I-0126 | None | None | None |