Tiotropium + Procaterol vs Tiotropium + Placebo in COPD Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2008-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Pulmonary Disease, Chronic Obstructive

Keywords

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Chronic Obstructive Pulmonary Disease Procaterol Tiotropium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Procaterol

Intervention Type DRUG

Tiotropium

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Otsuka Pharmaceutical, Inc., Philippines

Principal Investigators

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Abundio A Balgos, MD

Role: PRINCIPAL_INVESTIGATOR

University of the Philippines College of Medicine

Locations

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Philippine General Hospital

Manila, National Capital Region, Philippines

Site Status

Countries

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Philippines

Other Identifiers

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OPPI-MPTA-COPD-1

Identifier Type: -

Identifier Source: org_study_id