Asthma
Conditions
Keywords
oglemilast, asthma, allergen, prevention, prophylaxis, Allergen-Induced Asthma
Brief summary
The purpose of this study is to determine whether oglemilast is safe and effective in the treatment of allergen-induced asthma.
Interventions
DRUGOglemilast
Oglemilast, 15mg oral administration, once per day and then dose-matched placebo
DRUGPlacebo then Oglemilast
Dose-matched placebo and then Oglemilast, 15mg, oral administration, once per day.
Sponsors
Forest Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | From Baseline to Day 7 |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety of oglemilast over 2 weeks as determined by adverse events,physical examinations, vital signs, electrocardiograms, and laboratory examinations | From Baseline to Day 14 |
Countries
United States
Outcome results
None listed