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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00322283
Other study ID # GRC-MD-01
Secondary ID
Status Completed
Phase Phase 2
First received May 4, 2006
Last updated April 7, 2012
Start date May 2006
Est. completion date October 2006

Study information

Verified date April 2012
Source Forest Laboratories
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date October 2006
Est. primary completion date October 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 50 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Oglemilast
Oglemilast, 15mg once per day, oral administration
Placebo
Dose-marched placebo, once per day, oral administration

Locations

Country Name City State
United States Forest Investigative Site Los Angeles California
United States Forest Investigative Site N. Dartmouth Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To determine the efficacy of oglemilast as compared to placebo in preventing exercise-induced asthma following 15 days of treatment.
Secondary 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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