Status:
TERMINATED
Tiotropium + Procaterol vs Tiotropium + Placebo in COPD Patients
Lead Sponsor:
Otsuka Pharmaceutical, Inc., Philippines
Collaborating Sponsors:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40-75 years
Phase:
PHASE4
Brief Summary
Study compares the efficacy and safety of tiotropium + a beta agonist (procaterol) vs. tiotropium alone among patients with moderate chronic obstructive pulmonary disease
Detailed Description
This study aims to determine the efficacy and safety of tiotropium plus procaterol in comparison to tiotropium plus placebo in Filipino patients seen in Manila, with moderate COPD. After a 1-week was...
Eligibility Criteria
Inclusion
- GOLD criteria for moderate COPD (post-bronchodilator)
- FEV1/FVC \< 70%
- 50% ≤ FEV1 \< 80% predicted
- With or without symptoms
- Willing to undergo the treatment protocol with signed informed consent
Exclusion
- Exacerbation within 1 month prior to run-in period
- Significant hypoxemia and/or desaturation at rest and during exercise.
- Significant cardiac, renal, or other systemic disease
- History of adverse reaction to any of the two test drugs (tiotropium and procaterol)
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2008
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00394485
Start Date
May 1 2006
End Date
April 1 2008
Last Update
December 17 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Philippine General Hospital
Manila, National Capital Region, Philippines, 1000