Back to resultsStudy of Oglemilast for the Treatment of Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oglemilast
Placebo then Oglemilast
Sponsored by
About this trial
This is an interventional prevention trial for Asthma focused on measuring oglemilast, asthma, allergen, prevention, prophylaxis, Allergen-Induced Asthma
Eligibility Criteria
Inclusion Criteria: Mild atopic asthma Hyperreactivity to methacholine Exhibit positive response to standard allergen skin prick test Exclusion Criteria: Pulmonary disease other than asthma Asthma exacerbation within 4 weeks History of substance abuse Active cardiac disease
Sites / Locations
- Forest Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Oglemilast followed by placebo
Placebo followed by Oglemilast
Arm Description
Outcomes
Primary Outcome Measures
To determine the effect of oglemilast in the prevention of bronchoconstriction after the administration of allergen, in comparison with placebo in patients with mild asthma
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
NCT00322686
Brief Title
Study of Oglemilast for the Treatment of Asthma
Official Title
Efficacy and Safety of Oglemilast in the Prevention of Allergen-induced Bronchospasm
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether oglemilast is safe and effective in the treatment of allergen-induced asthma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
oglemilast, asthma, allergen, prevention, prophylaxis, Allergen-Induced Asthma
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oglemilast followed by placebo
Arm Type
Experimental
Arm Title
Placebo followed by Oglemilast
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Oglemilast
Intervention Description
Oglemilast, 15mg oral administration, once per day and then dose-matched placebo
Intervention Type
Drug
Intervention Name(s)
Placebo then Oglemilast
Intervention Description
Dose-matched placebo and then Oglemilast, 15mg, oral administration, once per day.
Primary Outcome Measure Information:
Title
To determine the effect of oglemilast in the prevention of bronchoconstriction after the administration of allergen, in comparison with placebo in patients with mild asthma
Time Frame
From Baseline to Day 7
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
Time Frame
From Baseline to Day 14
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:
Mild atopic asthma
Hyperreactivity to methacholine
Exhibit positive response to standard allergen skin prick test
Exclusion Criteria:
Pulmonary disease other than asthma
Asthma exacerbation within 4 weeks
History of substance abuse
Active cardiac disease
Facility Information:
Facility Name
Forest Investigative Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Oglemilast for the Treatment of Asthma
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