Study of Oglemilast for the Prevention of Asthma.

This study has been completed.
Sponsor:
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00322283
First received: May 4, 2006
Last updated: April 7, 2012
Last verified: April 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00322283     History of Changes
Other Study ID Numbers: GRC-MD-01
Study First Received: May 4, 2006
Last Updated: April 7, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 22, 2014