Zileuton and Exhaled Nitric Oxide in Asthmatics

Asthma Clinical Trial

Official title:

Evaluation of Additive Effects of Zileuton to Advair on Total Exhaled, Bronchial, and Alveolar Nitric Oxide in Asthmatics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00575861
• Other study ID #: 2000
• Secondary ID: Critical Therape
• Status: Completed
• Phase: Phase 4
• First received: December 15, 2007
• Last updated: December 18, 2007
• Start date: September 2005
• Est. completion date: November 2007

Study information

• Verified date: December 2007
• Source: Gelb, Arthur F., M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• zileuton
zileuton (Zyflo) 600mg qid for 2hr and for 30 days

Locations

Country	Name	City	State
United States	Arthur F Gelb Medical Corporation	Lakewood	California

Sponsors (1)

Lead Sponsor	Collaborator
Gelb, Arthur F., M.D.

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

Gelb AF, Taylor CF, Simmons M, Shinar C. Role of add-on zileuton on total exhaled, large airway, and small airway/alveolar nitric oxide in moderate-severe persistent adult asthmatics on fluticasone 250 microg/Salmeterol 50 microg. Pulm Pharmacol Ther. 2009 Dec;22(6):516-21. doi: 10.1016/j.pupt.2009.05.003. Epub 2009 May 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	nitric oxide gas exchange including total exhaled nitric oxide, bronchial and alveolar nitric oxide		2 hr to 1 month	No
Secondary	expiratory spirometry and asthma symptom Juniper score		2 hr to 1 month	No