Redox Determinants of Severe Asthma (a Substudy of the Severe Asthma Research Program)

Completed

• Conditions: Asthma

• Registration Number: NCT00590005
• Lead Sponsor: Emory University

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2003-01
• Study First Submitted: 2007-12-27
• Study First Submitted QC: 2008-01-09
• Study First Posted: 2008-01-10
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2013-07-10
• Results First Submitted QC: 2013-11-22
• Status Verified: 2014-01
• Results First Posted: 2014-01-13
• Last Update Submitted: 2014-01-14
• Last Update Posted: 2014-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

• At least 6 years old
• Asthma diagnosis by physician
• Current treatment with an inhaled corticosteroid medication

Exclusion criteria:

• Bronchiectasis
• Cystic Fibrosis
• Chronic Obstructive Pulmonary Disease

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Exhaled Nitric Oxide at Baseline and Over the Observational Period	baseline and after 21 days	Exhaled nitric oxide concentrations as measured by collection of exhaled breath into a mylar bag

Secondary Outcome Measures

Name	Time	Method
Reduction in Breath pH	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.

Trial Locations

Locations (1)

Emory Childrens Center; 🇺🇸 Atlanta, Georgia, United States