Tiotropium + Procaterol vs Tiotropium + Placebo in COPD Patients

This study has been terminated.
(Difficulty in recruting patients)
Otsuka Pharmaceutical Co., Ltd.
Information provided by:
Otsuka Pharmaceutical, Inc., Philippines
ClinicalTrials.gov Identifier:
First received: October 31, 2006
Last updated: December 15, 2009
Last verified: December 2009
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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized Crossover Trial Comparing the Efficacy and Safety of Tiotropium + Procaterol vs. Tiotropium + Placebo in Moderate COPD Patients

Resource links provided by NLM:

Further study details as provided by Otsuka Pharmaceutical, Inc., Philippines:

Primary Outcome Measures:
  • [Efficacy] Improvement spirometry (FEV1, FVC, FEV1/FVC, 6 MWD, TDI) and SGRQ at 2 weeks

Secondary Outcome Measures:
  • [Safety] HR (Heart Rate) and BP (Blood Pressure)
  • Incidence of adverse reactions and changes

Estimated Enrollment: 50
Study Start Date: May 2006
Estimated Study Completion Date: April 2008
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 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.


Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. GOLD criteria for moderate COPD (post-bronchodilator)

    • FEV1/FVC < 70%
    • 50% ≤ FEV1 < 80% predicted
    • With or without symptoms
  2. Willing to undergo the treatment protocol with signed informed consent

Exclusion Criteria:

  1. Exacerbation within 1 month prior to run-in period
  2. Significant hypoxemia and/or desaturation at rest and during exercise.
  3. Significant cardiac, renal, or other systemic disease
  4. History of adverse reaction to any of the two test drugs (tiotropium and procaterol)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394485

Philippine General Hospital
Manila, National Capital Region, Philippines, 1000
Sponsors and Collaborators
Otsuka Pharmaceutical, Inc., Philippines
Otsuka Pharmaceutical Co., Ltd.
Principal Investigator: Abundio A Balgos, MD University of the Philippines College of Medicine
  More Information

Responsible Party: Co, Benjamin, Medical Director, Otsuka Pharmaceutical, Inc., Philippines
ClinicalTrials.gov Identifier: NCT00394485     History of Changes
Other Study ID Numbers: OPPI-MPTA-COPD-1 
Study First Received: October 31, 2006
Last Updated: December 15, 2009
Health Authority: Philippines: Bureau of Food and Drugs

Keywords provided by Otsuka Pharmaceutical, Inc., Philippines:
Chronic Obstructive Pulmonary Disease

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases
Tiotropium Bromide
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents

ClinicalTrials.gov processed this record on May 26, 2016