Zileuton and Exhaled Nitric Oxide in Asthmatics
Information source: Gelb, Arthur F., M.D.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: zileuton (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Gelb, Arthur F., M.D.
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.
Clinical Details
Official title: Evaluation of Additive Effects of Zileuton to Advair on Total Exhaled, Bronchial, and Alveolar Nitric Oxide in Asthmatics
Study design: Treatment, Non-Randomized, Single Blind (Outcomes Assessor), Active Control, Crossover Assignment, Bio-equivalence Study
Primary outcome: nitric oxide gas exchange including total exhaled nitric oxide, bronchial and alveolar nitric oxide
Secondary outcome: expiratory spirometry and asthma symptom Juniper score
Eligibility
Minimum age: 21 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Arthur F Gelb Medical Corporation, Lakewood, California 90712, United States
Additional Information
Related publications: 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.
Starting date: September 2005
Ending date: November 2007
Last updated: December 18, 2007
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