Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
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
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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