Zileuton and Exhaled Nitric Oxide in Asthmatics

December 18, 2007 updated by: Gelb, Arthur F., M.D.

Evaluation of Additive Effects of Zileuton to Advair on Total Exhaled, Bronchial, and Alveolar 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Lakewood, California, United States, 90712
        • Arthur F Gelb Medical Corporation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Advair 250/50 (baseline) fluticasone/salmeterol 250/50
Drug: zileuton
zileuton (Zyflo) 600mg qid for 2hr and for 30 days
Other Names:
  • zyflo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gelb, Arthur F., M.D.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

December 15, 2007

First Submitted That Met QC Criteria

December 17, 2007

First Posted (Estimate)

December 18, 2007

Study Record Updates

Last Update Posted (Estimate)

December 20, 2007

Last Update Submitted That Met QC Criteria

December 18, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000
  • Critical Therapeutics, Inc.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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