Status:
UNKNOWN
A Clinical Study of Oglemilast in Patients With Mild to Moderate Persistent Asthma
Lead Sponsor:
Glenmark Pharmaceuticals Europe Ltd. (R&D)
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The study is aimed at evaluating efficacy and safety of oglemilast in the treatment of stable mild to moderate persistent asthma. The study involves two weeks of run in period. This is a placebo contr...
Eligibility Criteria
Inclusion
- Eligibility Criteria:
- Adult patients with a physician-documented diagnosis of chronic, stable, persistent, mild to moderate asthma (clinical symptoms and documented reversibility of airway obstruction, with an FEV1 of 60% to 85% of the predicted value).
- The following criteria must be met at the randomisation visit:
- At least 80% compliance during the single-blind placebo run-in period
- FEV1 between 60% and 85% of the predicted value
- Without asthma exacerbation during the run-in period
- Reversibility: patients are required to demonstrate a ≥ 12% increase in FEV1 (with an absolute improvement in FEV1 of at least 200mL) ≥ 10 min and up to 15 minutes after inhalation of 400 μg salbutamol via a spacer
- Any symptom score being ≥ 1 for at least 4 out of the last 7 days of the run-in
- Use of salbutamol for symptom relief on \> 2 occasions on at least 4 out of the last 7 days of the run-in
Exclusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2010
Estimated Enrollment :
282 Patients enrolled
Trial Details
Trial ID
NCT00859404
Start Date
October 1 2008
End Date
January 1 2010
Last Update
September 24 2009
Active Locations (1)
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1
Glenmark investigational sites (28)
Mumbai, Bangalore Etc, India