Zileuton and Exhaled Nitric Oxide in Asthmatics

Gelb, Arthur F., M.D.

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: zileuton

Study type: Interventional

Identifiers

NCT00575861

Critical Therapeutics, Inc.

2000

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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19 participants in 1 patient group

1

Active Comparator group

Description:

Advair 250/50 (baseline) fluticasone/salmeterol 250/50

Treatment:

Drug: zileuton