Study of Oglemilast for the Treatment of Asthma

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: Oglemilast; Drug: Placebo then Oglemilast

• Registration Number: NCT00322686
• Lead Sponsor: Forest Laboratories

Brief Summary

The purpose of this study is to determine whether oglemilast is safe and effective in the treatment of allergen-induced asthma.

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: 2006-05-08
• Primary Completion: 2006-12
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-16
• Last Update Posted: 2012-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Oglemilast followed by placebo	Oglemilast	-
Placebo followed by Oglemilast	Placebo then Oglemilast	-

Primary Outcome Measures

Name	Time	Method
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 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	From Baseline to Day 14

Trial Locations

Locations (1)

Forest Investigative Site; 🇺🇸 Los Angeles, California, United States