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Study of Oglemilast for the Prevention of Asthma.

This study has been completed.
Information provided by:
Forest Laboratories Identifier:
First received: May 4, 2006
Last updated: April 7, 2012
Last verified: April 2012
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.

Condition Intervention Phase
Exercise-Induced Asthma Drug: Oglemilast Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy and Safety of Oglemilast in the Prevention of Exercise-Induced Bronchospasm

Resource links provided by NLM:

Further study details as provided by Forest Laboratories:

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

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

Enrollment: 24
Study Start Date: May 2006
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oglemilast Drug: Oglemilast
Oglemilast, 15mg once per day, oral administration
Placebo Comparator: Placebo Drug: Placebo
Dose-marched placebo, once per day, oral administration


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00322283

United States, California
Forest Investigative Site
Los Angeles, California, United States, 90025
United States, Massachusetts
Forest Investigative Site
N. Dartmouth, Massachusetts, United States, 02747
Sponsors and Collaborators
Forest Laboratories
  More Information Identifier: NCT00322283     History of Changes
Other Study ID Numbers: GRC-MD-01
Study First Received: May 4, 2006
Last Updated: April 7, 2012

Keywords provided by Forest Laboratories:

Additional relevant MeSH terms:
Asthma, Exercise-Induced
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases processed this record on August 18, 2017