Redox Determinants in Severe Asthma (SARP)
Recruitment status was Recruiting
Hypotheses: 1) Airway pH regulation is abnormal in severe asthma; 2) In severe asthma, there is formation of cytotoxic nitrogen oxides and loss of beneficial nitrogen oxides in the airways
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Redox Determinants in Severe Asthma|
- improvemewnt in post-bronchodilator FEV1 (cut point 15% [ Time Frame: 21 days ] [ Designated as safety issue: No ]
- Reduction in exhaled NO (cut point 25%) [ Time Frame: 21 days ] [ Designated as safety issue: No ]
- Increasze in breath pH (cut point 10%) [ Time Frame: 21 days ] [ Designated as safety issue: No ]
|Study Start Date:||July 2006|
|Estimated Study Completion Date:||June 2008|
|Estimated Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
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.
|United States, Georgia|
|Emory Childrens Center||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Eric Hunter, BS 404-727-3691 firstname.lastname@example.org|
|Principal Investigator: William G Teague, MD|