Status:
COMPLETED
Study To Assess Efficacy and Safety of Oglemilast in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Forest Laboratories
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
This study will assess the safety and efficacy of a range of oglemilast doses. The study will be 14 weeks in duration. All patients meeting the eligibility criteria will be randomized to one of three ...
Eligibility Criteria
Inclusion
- Presence of COPD as defined by GOLD criteria (2006); post-bronchodilator FEV1/FVC \<70%, and post-bronchodilator FEV1 \>30% and \< 80% predicted
- Current or former cigarette smoker
Exclusion
- Long-term oxygen use of \> 15 hours a day
- Symptoms consistent with a significant asthmatic component (e.g. atopic disease, allergic symptoms)
- Any COPD exacerbations within 30 days prior to study entry or during run-in
- History of chronic or recurrent gastrointestinal disorder associated with bleeding in previous 12 months
- Presence of clinical significant pulmonary disease other than COPD
Key Trial Info
Start Date :
May 5 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2009
Estimated Enrollment :
427 Patients enrolled
Trial Details
Trial ID
NCT00671073
Start Date
May 5 2008
End Date
May 15 2009
Last Update
September 19 2019
Active Locations (47)
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1
Forest Investigative Site
Birmingham, Alabama, United States, 35215
2
Forest Investigative Site
Phoenix, Arizona, United States, 85006
3
Forest Investigative Site
Tucson, Arizona, United States, 85715
4
Forest Investigative Site
Buena Park, California, United States, 90620