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