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Completed

NCT Number: NCT00575861

Zileuton and Exhaled Nitric Oxide in Asthmatics

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Arthur F Gelb Medical Corporation

Lakewood, California, 90712, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

zileuton

Drug

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

Other names: zyflo

Primary outcomes

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

    Time frame: 2 hr to 1 month

Secondary outcomes

  1. expiratory spirometry and asthma symptom Juniper score

    Time frame: 2 hr to 1 month

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Gelb, Arthur F., M.D.

Indiv

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2007
First posted
Dec 18, 2007
Registry last updated
Dec 20, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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