Study of Oglemilast for the Prevention of Asthma.

NCT ID: NCT00322283

Last Updated: 2012-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2006-10-31

Brief Summary

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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

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Conditions

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Exercise-Induced Asthma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Oglemilast

Group Type EXPERIMENTAL

Oglemilast

Intervention Type DRUG

Oglemilast, 15mg once per day, oral administration

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Dose-marched placebo, once per day, oral administration

Interventions

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Oglemilast

Oglemilast, 15mg once per day, oral administration

Intervention Type DRUG

Placebo

Dose-marched placebo, once per day, oral administration

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Forest Laboratories

INDUSTRY

Sponsor Role lead

Locations

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Forest Investigative Site

Los Angeles, California, United States

Site Status

Forest Investigative Site

North Dartmouth, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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GRC-MD-01

Identifier Type: -

Identifier Source: org_study_id

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