Study of Oglemilast for the Prevention of Asthma.

Forest Laboratories24 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Exercise-Induced Asthma

Interventions

OglemilastDRUG

Oglemilast, 15mg once per day, oral administration

PlaceboDRUG

Dose-marched placebo, once per day, oral administration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (2)

Forest Investigative Site

Los Angeles, California, United States

Forest Investigative Site

North Dartmouth, Massachusetts, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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