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...
Date First Received: December 15, 2007
Last Updated: December 18, 2007
Verified by: Gelb, Arthur F., M.D., December 2007
Clinical Trial Phase: Phase 4 | Start Date: September 2005
Overall Status: Completed
Estimated Enrollment: 19
Brief Summary
Official Title: “Evaluation of Additive Effects of Zileuton to Advair on Total Exhaled, Bronchial, and Alveolar Nitric Oxide in Asthmatics”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Single Blind (Outcomes Assessor), Active Control, Crossover Assignment, Bio-equivalence Study
Intervention(s) in this Clinical Trial
- Drug: zileuton
- zileuton (Zyflo) 600mg qid for 2hr and for 30 days
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- Advair 250/50 (baseline) fluticasone/salmeterol 250/50
Outcome Measures for this Clinical Trial
Primary Measures
- nitric oxide gas exchange including total exhaled nitric oxide, bronchial and alveolar nitric oxide
- Time Frame: 2 hr to 1 month
Safety Issue?: No
- Time Frame: 2 hr to 1 month
Secondary Measures
- expiratory spirometry and asthma symptom Juniper score
- Time Frame: 2 hr to 1 month
Safety Issue?: No
- Time Frame: 2 hr to 1 month
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 21 Years
Maximum Age for this Clinical Trial: 80 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Gelb, Arthur F., M.D.
Related Publications
References
Gelb AF, Flynn Taylor C, Shinar C, et al. Additive role of zileuton on total exhaled, bronchial, alveolar nitric oxide in non-atopic moderate to severe persistent asthmatics on fluticasone 250/salmeterol 50. Chest 2006;130:163S
Gelb AF, Flynn Taylor C, Shinar CM, Gutierrez C, Zamel N. Role of spirometry and exhaled nitric oxide to predict exacerbations in treated asthmatics. Chest. 2006 Jun;129(6):1492-9.
Gelb AF, Taylor CF, Nussbaum E, Gutierrez C, Schein A, Shinar CM, Schein MJ, Epstein JD, Zamel N. Alveolar and airway sites of nitric oxide inflammation in treated asthma. Am J Respir Crit Care Med. 2004 Oct 1;170(7):737-41. Epub 2004 Jun 30.
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00575861
Study ID Number: 2000
ClinicalTrials.gov Identifier: NCT00575861
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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