Redox Determinants of Severe Asthma (a Substudy of the Severe Asthma Research Program) (SARP)
|ClinicalTrials.gov Identifier: NCT00590005|
Recruitment Status : Completed
First Posted : January 10, 2008
Results First Posted : January 13, 2014
Last Update Posted : February 10, 2014
|Condition or disease|
Specific Aim 1:Test hypothesis that airway pH regulation is abnormal in severe asthma.
1a) Determine the effects of systemic corticosteroids on breath pH in children with severe and mild to moderate asthma.
1b) Examine whether breath condensate pH and other biomarkers of oxidant stress can predict clinical outcomes in children with severe and mild to moderate asthma.
1c) Identify whether increased Th1/Th2 cytokine ratio, and abnormalities in airway glutaminase, G-SNO-reductase, VATPase, and carbonic anhydrase are associated with airway pH disturbance in children with severe asthma.
1d) Test whether rhinovirus infections, which reduce airway pH, persist longer or are more frequent in children with severe asthma than in children with mild to moderate asthma.
1e) Examine the relationship between gastroesophageal reflux and proximal airway pH in children with severe asthma and mild to moderate asthma.
|Study Type :||Observational|
|Actual Enrollment :||225 participants|
|Official Title:||Redox Determinants of Severe Asthma: A Substudy of the NHLBI Severe Asthma Research Program|
|Study Start Date :||January 2003|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
Children with severe asthma
This group consists of children with severe asthma as defined per ATS workshop criteria (published in 2000).
Children with non-severe asthma
This group includes children with asthma who do not meet the ATS criteria for severe asthma as outlined in the 2000 workshop report.
- Exhaled Nitric Oxide at Baseline and Over the Observational Period [ Time Frame: baseline and after 21 days ]Exhaled nitric oxide concentrations as measured by collection of exhaled breath into a mylar bag
- Reduction in Breath pH [ Time Frame: baseline and 21 days ]Breath condensate pH was measured by the RTube (trademark) device. This device is a plastic tube with a one-way exhalation valve and a chilled aluminum sleeve. pH (the log of hydrogen ion concentration) was measured using an Orion pH meter and probe calibrated in 4.0, 7.0, and 10.0 pH solutions.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00590005
|United States, Georgia|
|Emory Childrens Center|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||W G Teague, MD||University of Virginia|