Single Dose Bronchodilatory Study in Asthma
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
1 other identifier
interventional
25
1 country
1
Brief Summary
Study to evaluate the bronchodilator effects of Zyflo CR in patients with chronic stable asthma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 5, 2013
CompletedFirst Posted
Study publicly available on registry
March 6, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedResults Posted
Study results publicly available
August 18, 2014
CompletedSeptember 3, 2014
August 1, 2014
3 months
March 5, 2013
July 30, 2014
August 22, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in FEV1
12 Hours
Secondary Outcomes (2)
Area Under the Curve (AUC)
72 Hours
Number of Subjects With Adverse Events
72 Hours
Study Arms (1)
Zileuton extended release
OTHEROral, 1200 mg (2 x 600 mg tablets)
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of asthma for at least 5 years
- FEV1 of 50-85% predicted
- Reversible airway obstruction
You may not qualify if:
- Pregnant/nursing females
- Liver function tests greater than upper limit of normal
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northeast Medical Research Associates
North Dartmouth, Massachusetts, 02747, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- W. James Alexander, MD, MPH
- Organization
- Cornerstone Therapeutics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2013
First Posted
March 6, 2013
Study Start
March 1, 2013
Primary Completion
June 1, 2013
Last Updated
September 3, 2014
Results First Posted
August 18, 2014
Record last verified: 2014-08