Zileuton and Exhaled Nitric Oxide in Asthmatics
- Registration Number
- NCT00575861
- Lead Sponsor
- Gelb, Arthur F., M.D.
- Brief Summary
Evaluate the additive role of zileuton 600mg qid to clinically stable asthmatics on Advair 250/50 bid. Since asthma is an endogenous inflammatory disease there usually is increased total exhaled, bronchial and alveolar nitric oxide which are markers of eosinophilic driven pathways of inflammation. The addition of zileuton which is a leukotriene synthesis inhibitor by itself or together with inhaled corticosteroids should reduce nitric oxide gas exchange.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
Inclusion Criteria
- Non-smoking
- Moderate to severe persistent asthmatics
- Clinically stable X 6 weeks on Advair 250/50 bid for at least 12 months
Exclusion Criteria
- No leukotriene synthesis inhibitors or receptor antagonists for 6 weeks
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 zileuton Advair 250/50 (baseline) fluticasone/salmeterol 250/50
- Primary Outcome Measures
Name Time Method nitric oxide gas exchange including total exhaled nitric oxide, bronchial and alveolar nitric oxide 2 hr to 1 month
- Secondary Outcome Measures
Name Time Method expiratory spirometry and asthma symptom Juniper score 2 hr to 1 month
Trial Locations
- Locations (1)
Arthur F Gelb Medical Corporation
🇺🇸Lakewood, California, United States