Study of Oglemilast for the Treatment of Asthma

March 16, 2012 updated by: Forest Laboratories

Efficacy and Safety of Oglemilast in the Prevention of Allergen-induced Bronchospasm

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90025
        • Forest Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oglemilast followed by placebo
Drug: Oglemilast
Oglemilast, 15mg oral administration, once per day and then dose-matched placebo
Experimental: Placebo followed by Oglemilast
Drug: Placebo then Oglemilast
Dose-matched placebo and then Oglemilast, 15mg, oral administration, once per day.

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: From Baseline to Day 7
From Baseline to Day 7

Secondary Outcome Measures

Outcome 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
Time Frame: From Baseline to Day 14
From Baseline to Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

May 4, 2006

First Submitted That Met QC Criteria

May 4, 2006

First Posted (Estimate)

May 8, 2006

Study Record Updates

Last Update Posted (Estimate)

March 20, 2012

Last Update Submitted That Met QC Criteria

March 16, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRC-MD-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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