Study of Oglemilast for the Prevention of Asthma.

Phase 2

Completed

• Conditions: Exercise-Induced Asthma
• Interventions: Drug: Placebo; Drug: Oglemilast

• Registration Number: NCT00322283
• Lead Sponsor: Forest Laboratories

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-04
• Study First Submitted QC: 2006-05-04
• Study First Posted: 2006-05-05
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-07
• Last Update Posted: 2012-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Oglemilast	Oglemilast	-

Primary Outcome Measures

Name	Time	Method
To determine the efficacy of oglemilast as compared to placebo in preventing exercise-induced asthma following 15 days of treatment.

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety of oglemilast over 2 weeks as determined by adverse events, physical examinations, vital signs, electrocardiograms, and laboratory examinations.

Trial Locations

Locations (1)

Forest Investigative Site; 🇺🇸 N. Dartmouth, Massachusetts, United States