Zileuton and Exhaled Nitric Oxide in Asthmatics

Gelb, Arthur F., M.D.19 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Asthma

Interventions

zileutonDRUG

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

Eligibility

Sex: ALLMin age: 21 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 (1)

Arthur F Gelb Medical Corporation

Lakewood, California, United States

Outcomes

Primary Outcomes

nitric oxide gas exchange including total exhaled nitric oxide, bronchial and alveolar nitric oxide

Time frame: 2 hr to 1 month

Secondary Outcomes

expiratory spirometry and asthma symptom Juniper score

Time frame: 2 hr to 1 month

Data from ClinicalTrials.gov

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