Tiotropium + Procaterol vs Tiotropium + Placebo in COPD Patients
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|ClinicalTrials.gov Identifier: NCT00394485|
Recruitment Status : Terminated (Difficulty in recruting patients)
First Posted : November 1, 2006
Last Update Posted : December 17, 2009
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Disease, Chronic Obstructive||Drug: Procaterol Drug: Tiotropium||Phase 4|
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 wash-out period, 6-minute walk test, and St. George's Respiratory Questionnaire (SGRQ) will then be administered prior to a run-in period of 1 week wherein all patients will be started on tiotropium alone. The patients will then be randomly allocated to either of the two arms for a two-week treatment, followed by one week washout, and crossed-over to the other treatment for another two weeks. The procaterol or placebo dose is given 2 hrs after the tiotropium dose.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||A Randomized Crossover Trial Comparing the Efficacy and Safety of Tiotropium + Procaterol vs. Tiotropium + Placebo in Moderate COPD Patients|
|Study Start Date :||May 2006|
|Study Completion Date :||April 2008|
- [Efficacy] Improvement spirometry (FEV1, FVC, FEV1/FVC, 6 MWD, TDI) and SGRQ at 2 weeks
- [Safety] HR (Heart Rate) and BP (Blood Pressure)
- Incidence of adverse reactions and changes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00394485
|Philippine General Hospital|
|Manila, National Capital Region, Philippines, 1000|
|Principal Investigator:||Abundio A Balgos, MD||University of the Philippines College of Medicine|