Single Dose Bronchodilatory Study in Asthma

Overview

Study to evaluate the bronchodilator effects of Zyflo CR in patients with chronic stable asthma.

Full Title of Study: “A Single-Center, Open-Label, Single-Dose Evaluation of the Duration and Extent of Bronchodilation Following Administration of Zileuton CR 1200 mg in Subjects With Stable, Chronic Asthma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2013

Interventions

  • Drug: Zileuton extended release

Arms, Groups and Cohorts

  • Other: Zileuton extended release
    • Oral, 1200 mg (2 x 600 mg tablets)

Clinical Trial Outcome Measures

Primary Measures

  • Change From Baseline in FEV1
    • Time Frame: 12 Hours

Secondary Measures

  • Area Under the Curve (AUC)
    • Time Frame: 72 Hours
  • Number of Subjects With Adverse Events
    • Time Frame: 72 Hours

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosis of asthma for at least 5 years – FEV1 of 50-85% predicted – Reversible airway obstruction Exclusion Criteria:

  • Pregnant/nursing females – Liver function tests greater than upper limit of normal

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cornerstone Therapeutics Inc.
  • Provider of Information About this Clinical Study
    • Sponsor

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