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Tiotropium + Procaterol vs Tiotropium + Placebo in COPD Patients

This study has been terminated.
(Difficulty in recruting patients)
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by:
Otsuka Pharmaceutical, Inc., Philippines
ClinicalTrials.gov Identifier:
NCT00394485
First received: October 31, 2006
Last updated: December 15, 2009
Last verified: December 2009
History of Changes
  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 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:

U.S. FDA Resources

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.

  Eligibility

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

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

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

No publications provided

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
Procaterol
Tiotropium

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

ClinicalTrials.gov processed this record on May 22, 2013