Back to resultsSingle Dose Bronchodilatory Study in Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Zileuton extended release
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
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
Sites / Locations
- Northeast Medical Research Associates
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Zileuton extended release
Arm Description
Oral, 1200 mg (2 x 600 mg tablets)
Outcomes
Primary Outcome Measures
Change From Baseline in FEV1
Secondary Outcome Measures
Area Under the Curve (AUC)
Number of Subjects With Adverse Events
Full Information
NCT ID
NCT01805687
First Posted
March 5, 2013
Last Updated
August 22, 2014
Sponsor
Cornerstone Therapeutics Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01805687
Brief Title
Single Dose Bronchodilatory Study in Asthma
Official Title
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
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cornerstone Therapeutics Inc.
4. Oversight
5. Study Description
Brief Summary
Study to evaluate the bronchodilator effects of Zyflo CR in patients with chronic stable asthma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Zileuton extended release
Arm Type
Other
Arm Description
Oral, 1200 mg (2 x 600 mg tablets)
Intervention Type
Drug
Intervention Name(s)
Zileuton extended release
Primary Outcome Measure Information:
Title
Change From Baseline in FEV1
Time Frame
12 Hours
Secondary Outcome Measure Information:
Title
Area Under the Curve (AUC)
Time Frame
72 Hours
Title
Number of Subjects With Adverse Events
Time Frame
72 Hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Northeast Medical Research Associates
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
12. IPD Sharing Statement
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Single Dose Bronchodilatory Study in Asthma
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