Clinical Outcomes of Tiotropium Plus Fluticasone Propionate/Salmeterol Compared With Tiotropium for Chronic Obstructive Pulmonary Disease (COPD) in Korea

Summary

Study title * A randomized, open label, multicenter, phase 4 study for the comparison of efficacy of tiotropium plus salmeterol/ fluticasone propionate compared with tiotropium alone in COPD patients Study objectives * To investigate clinical outcomes of combining tiotropium with fluticasone propionate/salmeterol (FSC) 250/50μg bid compared with tiotropium alone in patients with moderate or severe COPD in Korea Study Design * Randomized, open-label, multicenter, parallel-group, two group study Study assessment * FEV1 * Inspiratory capacity (IC) * History of COPD exacerbation * History of hospitalization for COPD exacerbation and all causes * QoL (SGRQ-C)

Timeline

Start

2009-03

Primary completion

2010-03

Completion

2010-03

Drugs

Indications