Single Dose Bronchodilatory Study in Asthma

Phase 4

Completed

• Conditions: Asthma
• Interventions: Drug: Zileuton extended release

• Registration Number: NCT01805687
• Lead Sponsor: Cornerstone Therapeutics Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-05
• Study First Submitted QC: 2013-03-05
• Study First Posted: 2013-03-06
• Primary Completion: 2013-06
• Results First Submitted: 2014-07-30
• Results First Submitted QC: 2014-07-30
• Status Verified: 2014-08
• Results First Posted: 2014-08-18
• Last Update Submitted: 2014-08-22
• Last Update Posted: 2014-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Zileuton extended release	Zileuton extended release	Oral, 1200 mg (2 x 600 mg tablets)

Primary Outcome Measures

Name	Time	Method
Change From Baseline in FEV1	12 Hours

Secondary Outcome Measures

Name	Time	Method
Area Under the Curve (AUC)	72 Hours
Number of Subjects With Adverse Events	72 Hours

Trial Locations

Locations (1)

Northeast Medical Research Associates; 🇺🇸 North Dartmouth, Massachusetts, United States