Zileuton and Exhaled Nitric Oxide in Asthmatics

Overview

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.

Full Title of Study: “Evaluation of Additive Effects of Zileuton to Advair on Total Exhaled, Bronchial, and Alveolar Nitric Oxide in Asthmatics”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Non-Randomized
  • Intervention Model: Crossover Assignment
  • Primary Purpose: Treatment
  • Masking: Single (Outcomes Assessor)

Interventions

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

Arms, Groups and Cohorts

• Active Comparator: 1
  • Advair 250/50 (baseline) fluticasone/salmeterol 250/50

Clinical Trial Outcome Measures

Primary Measures

• nitric oxide gas exchange including total exhaled nitric oxide, bronchial and alveolar nitric oxide
  • Time Frame: 2 hr to 1 month

Secondary Measures

• expiratory spirometry and asthma symptom Juniper score
  • Time Frame: 2 hr to 1 month

Participating 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: All

Minimum Age: 21 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Gelb, Arthur F., M.D.
• Provider of Information About this Clinical Study
  • Arthur F. Gelb MD, Arthur F. Gelb Medical Corporation

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.