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Tiotropium + Procaterol vs Tiotropium + Placebo in COPD Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00394485
Recruitment Status : Terminated (Difficulty in recruting patients)
First Posted : November 1, 2006
Last Update Posted : December 17, 2009
Otsuka Pharmaceutical Co., Ltd.
Information provided by:
Otsuka Pharmaceutical, Inc., Philippines

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

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: Procaterol Drug: Tiotropium Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

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 identifier (NCT number): NCT00394485

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

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Responsible Party: Co, Benjamin, Medical Director, Otsuka Pharmaceutical, Inc., Philippines Identifier: NCT00394485     History of Changes
Other Study ID Numbers: OPPI-MPTA-COPD-1
First Posted: November 1, 2006    Key Record Dates
Last Update Posted: December 17, 2009
Last Verified: December 2009
Keywords provided by Otsuka Pharmaceutical, Inc., Philippines:
Chronic Obstructive Pulmonary Disease
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lung Diseases, Obstructive
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents