Zileuton and Exhaled Nitric Oxide in Asthmatics

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00575861

Enrollment

Registered

2007-12-18

Start date

2005-09-30

Completion date

2007-11-30

Last updated

2007-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

asthma, nitric oxide gas exchange, lung function

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.

Interventions

DRUGzileuton

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
nitric oxide gas exchange including total exhaled nitric oxide, bronchial and alveolar nitric oxide	2 hr to 1 month

Secondary

Measure	Time frame
expiratory spirometry and asthma symptom Juniper score	2 hr to 1 month

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026