Back to resultsStudy of Oglemilast for the Prevention of Asthma.
Primary Purpose
Exercise-Induced Asthma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oglemilast
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Exercise-Induced Asthma focused on measuring oglemilast, asthma, exercise, prevention, prophylaxis
Eligibility Criteria
Inclusion Criteria: stable mild asthma patients who exhibit at least a 20% decrease in FEV1 following exercise. Exclusion Criteria: pulmonary disease other than asthma, psychiatric illness, active cardiac disease, high blood pressure, history of substance abuse, current smokers.
Sites / Locations
- Forest Investigative Site
- Forest Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Oglemilast
Placebo
Arm Description
Outcomes
Primary Outcome Measures
To determine the efficacy of oglemilast as compared to placebo in preventing exercise-induced asthma following 15 days of treatment.
Secondary Outcome Measures
To evaluate the safety of oglemilast over 2 weeks as determined by adverse events, physical examinations, vital signs, electrocardiograms, and laboratory examinations.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00322283
Brief Title
Study of Oglemilast for the Prevention of Asthma.
Official Title
Efficacy and Safety of Oglemilast in the Prevention of Exercise-Induced Bronchospasm
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Forest Laboratories
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether it is effective in the treatment of exercise-induced asthma and investigate the safety of oglemilast.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise-Induced Asthma
Keywords
oglemilast, asthma, exercise, prevention, prophylaxis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oglemilast
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Oglemilast
Intervention Description
Oglemilast, 15mg once per day, oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dose-marched placebo, once per day, oral administration
Primary Outcome Measure Information:
Title
To determine the efficacy of oglemilast as compared to placebo in preventing exercise-induced asthma following 15 days of treatment.
Secondary Outcome Measure Information:
Title
To evaluate the safety of oglemilast over 2 weeks as determined by adverse events, physical examinations, vital signs, electrocardiograms, and laboratory examinations.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
stable mild asthma patients who exhibit at least a 20% decrease in FEV1 following exercise.
Exclusion Criteria:
pulmonary disease other than asthma, psychiatric illness, active cardiac disease, high blood pressure, history of substance abuse, current smokers.
Facility Information:
Facility Name
Forest Investigative Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Forest Investigative Site
City
N. Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Oglemilast for the Prevention of Asthma.
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