Study of Oglemilast for the Prevention of Asthma.

Exercise-Induced Asthma Clinical Trial

Official title:

Efficacy and Safety of Oglemilast in the Prevention of Exercise-Induced Bronchospasm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00322283
• Other study ID #: GRC-MD-01
• 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

• Asthma, Exercise-Induced
• Exercise-Induced Asthma

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.