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Study of Oglemilast for the Prevention of Asthma.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00322283
First Posted: May 5, 2006
Last Update Posted: April 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Forest Laboratories
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.
  Contacts and Locations
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
  More Information

ClinicalTrials.gov Identifier: NCT00322283     History of Changes
Other Study ID Numbers: GRC-MD-01
First Submitted: May 4, 2006
First Posted: May 5, 2006
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