Tiotropium + Procaterol vs Tiotropium + Placebo in COPD Patients

Phase 4TerminatedNCT00394485

Otsuka Pharmaceutical, Inc., Philippines50 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

ProcaterolDRUG

TiotropiumDRUG

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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)

Locations (1)

Philippine General Hospital

Manila, National Capital Region, Philippines

Outcomes

Primary Outcomes

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

Secondary Outcomes

[Safety] HR (Heart Rate) and BP (Blood Pressure)

Incidence of adverse reactions and changes

Data from ClinicalTrials.gov

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