Tiotropium + Procaterol vs Tiotropium + Placebo in COPD Patients

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00394485

Enrollment

Registered

2006-11-01

Start date

2006-05-31

Completion date

2008-04-30

Last updated

2009-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Chronic Obstructive Pulmonary Disease, Procaterol, Tiotropium

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

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.

Interventions

DRUGProcaterol

DRUGTiotropium

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

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

Countries

Philippines

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026