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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