Study of Oglemilast for the Prevention of Asthma.

April 7, 2012 updated by: Forest Laboratories

Efficacy and Safety of Oglemilast in the Prevention of Exercise-Induced Bronchospasm

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

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
    • Massachusetts
      • N. Dartmouth, Massachusetts, United States, 02747
        • 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:

  • 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 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: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Dose-marched placebo, once per day, oral administration
EXPERIMENTAL: Oglemilast
Drug: Oglemilast
Oglemilast, 15mg once per day, oral administration

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

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)

October 1, 2006

Study Completion (ACTUAL)

October 1, 2006

Study Registration Dates

First Submitted

May 4, 2006

First Submitted That Met QC Criteria

May 4, 2006

First Posted (ESTIMATE)

May 5, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

April 10, 2012

Last Update Submitted That Met QC Criteria

April 7, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRC-MD-01

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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