Tiotropium + Procaterol vs Tiotropium + Placebo in COPD Patients

Otsuka

Status and phase: Terminated; Phase 4

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Tiotropium; Drug: Procaterol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00394485

OPPI-MPTA-COPD-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind