Tiotropium + Procaterol vs Tiotropium + Placebo in COPD Patients

December 15, 2009 updated by: Otsuka Pharmaceutical, Inc., Philippines

A Randomized Crossover Trial Comparing the Efficacy and Safety of Tiotropium + Procaterol vs. Tiotropium + Placebo in Moderate COPD Patients

Study compares the efficacy and safety of tiotropium + a beta agonist (procaterol) vs. tiotropium alone among patients with moderate chronic obstructive pulmonary disease

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Philippines
    • National Capital Region
      • Manila, National Capital Region, Philippines, 1000
        • Philippine General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
[Safety] HR (Heart Rate) and BP (Blood Pressure)
Incidence of adverse reactions and changes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical, Inc., Philippines

Collaborators

Otsuka Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Abundio A Balgos, MD, University of the Philippines College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Study Completion

April 1, 2008

Study Registration Dates

First Submitted

October 31, 2006

First Submitted That Met QC Criteria

October 31, 2006

First Posted (Estimate)

November 1, 2006

Study Record Updates

Last Update Posted (Estimate)

December 17, 2009

Last Update Submitted That Met QC Criteria

December 15, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPPI-MPTA-COPD-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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