Zileuton and Exhaled Nitric Oxide in Asthmatics
Sponsor
Gelb, Arthur F., M.D. (Other)
Overall Status
Completed
CT.gov ID
NCT00575861
Collaborator
(none)
19
1
1
26
0.7
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
19 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Evaluation of Additive Effects of Zileuton to Advair on Total Exhaled, Bronchial, and Alveolar Nitric Oxide in Asthmatics
Study Start Date
:
Sep 1, 2005
Actual Study Completion Date
:
Nov 1, 2007
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 1 Advair 250/50 (baseline) fluticasone/salmeterol 250/50 |
Drug: zileuton
zileuton (Zyflo) 600mg qid for 2hr and for 30 days
Other Names:
|
Outcome Measures
Primary Outcome Measures
- nitric oxide gas exchange including total exhaled nitric oxide, bronchial and alveolar nitric oxide [2 hr to 1 month]
Secondary Outcome Measures
- expiratory spirometry and asthma symptom Juniper score [2 hr to 1 month]
Eligibility Criteria
Criteria
Ages Eligible for Study:
21 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Arthur F Gelb Medical Corporation | Lakewood | California | United States | 90712 |
Sponsors and Collaborators
- Gelb, Arthur F., M.D.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
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.
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00575861
Other Study ID Numbers:
- 2000
- Critical Therapeutics, Inc.
First Posted:
Dec 18, 2007
Last Update Posted:
Dec 20, 2007
Last Verified:
Dec 1, 2007
Keywords provided by ,
,
Additional relevant MeSH terms: