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| Sponsors and Collaborators: |
Otsuka Pharmaceutical, Inc., Philippines Otsuka Pharmaceutical Co., Ltd. |
|---|---|
| Information provided by: | Otsuka Pharmaceutical, Inc., Philippines |
| ClinicalTrials.gov Identifier: | NCT00394485 |
Purpose
Study compares the efficacy and safety of tiotropium + a beta agonist (procaterol) vs. tiotropium alone among patients with moderate chronic obstructive pulmonary disease
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Disease, Chronic Obstructive |
Drug: Procaterol Drug: Tiotropium |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized Crossover Trial Comparing the Efficacy and Safety of Tiotropium + Procaterol vs. Tiotropium + Placebo in Moderate COPD Patients |
| Estimated Enrollment: | 50 |
| Study Start Date: | May 2006 |
| Estimated Study Completion Date: | April 2008 |
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.
Eligibility| Ages Eligible for Study: | 40 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
GOLD criteria for moderate COPD (post-bronchodilator)
Exclusion Criteria:
Contacts and Locations| Contact: Abundio A Balgos, MD | 5256046 | abalgos@mydestiny.net |
| Contact: Camilo Roa, MD | 5256046 | camiloroa@yahoo.com |
| Philippines, National Capital Region | |
| Philippine General Hospital | Recruiting |
| Manila, National Capital Region, Philippines, 1000 | |
| Contact: Eleanor Dominguez, MD 5256046 | |
| Sub-Investigator: Eleanor Dominguez, MD | |
| Principal Investigator: | Abundio A Balgos, MD | University of the Philippines College of Medicine |
More Information
| Study ID Numbers: | OPPI-MPTA-COPD-1 |
| Study First Received: | October 31, 2006 |
| Last Updated: | May 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00394485 |
| Health Authority: | Philippines: Bureau of Food and Drugs |
|
Chronic Obstructive Pulmonary Disease Procaterol Tiotropium |
|
Procaterol Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases |
Respiration Disorders Chronic Disease Tiotropium Pulmonary Disease, Chronic Obstructive |
|
Parasympatholytics Respiratory System Agents Disease Attributes Neurotransmitter Agents Cholinergic Antagonists Adrenergic beta-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Sympathomimetics Physiological Effects of Drugs |
Anti-Asthmatic Agents Cholinergic Agents Adrenergic Agonists Pharmacologic Actions Pathologic Processes Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |
