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Study of Oglemilast for the Prevention of Asthma.

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00322283
Enrollment
24
Registered
2006-05-05
Start date
2006-05-31
Completion date
2006-10-31
Last updated
2012-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise-Induced Asthma

Keywords

oglemilast, asthma, exercise, prevention, prophylaxis

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.

Interventions

Oglemilast, 15mg once per day, oral administration

DRUGPlacebo

Dose-marched placebo, once per day, oral administration

Sponsors

Forest Laboratories
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
To determine the efficacy of oglemilast as compared to placebo in preventing exercise-induced asthma following 15 days of treatment.

Secondary

MeasureTime frame
To evaluate the safety of oglemilast over 2 weeks as determined by adverse events, physical examinations, vital signs, electrocardiograms, and laboratory examinations.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026