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Study of Oglemilast for the Prevention of Asthma.

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ClinicalTrials.gov Identifier: NCT00322283
Recruitment Status : Completed
First Posted : May 5, 2006
Last Update Posted : April 10, 2012
Sponsor:
Information provided by:
Forest Laboratories

Brief Summary:
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 or disease Intervention/treatment Phase
Exercise-Induced Asthma Drug: Oglemilast Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
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
Study Start Date : May 2006
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Oglemilast Drug: Oglemilast
Oglemilast, 15mg once per day, oral administration

Placebo Comparator: Placebo Drug: Placebo
Dose-marched placebo, once per day, oral administration




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

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


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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00322283


Locations
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

ClinicalTrials.gov Identifier: NCT00322283     History of Changes
Other Study ID Numbers: GRC-MD-01
First Posted: May 5, 2006    Key Record Dates
Last Update Posted: April 10, 2012
Last Verified: April 2012

Keywords provided by Forest Laboratories:
oglemilast
asthma
exercise
prevention
prophylaxis

Additional relevant MeSH terms:
Asthma
Asthma, Exercise-Induced
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases