A 24-week (+ 24 Week Extension) Placebo-controlled (Only 1st 12-week Period), Double-Blind, Parallel-group, Efficacy and Safety Comparison of Fixed-dose Combination (FDC) Tiotropium/Salmeterol, Tiotropium, Salmeterol and FDC Tiotropium/Salmeterol Plus Salmeterol in Chronic Obstructive Pulmonary Disease (COPD) Patients
A 24-week (+ 24 Week Extension) Placebo-controlled (Only 1st 12-week Period), Double-Blind, Parallel-group, Efficacy and Safety Comparison of Fixed-dose Combination (FDC) Tiotropium/Salmeterol, Tiotropium, Salmeterol and FDC Tiotropium/Salmeterol Plus Salmeterol in Chronic Obstructive Pulmonary Disease (COPD) Patients
The primary objectives of this study are to assess bronchodilator efficacy as determined by forced expiratory volume in one second (FEV1), the effect on dyspnoea as determined by the Baseline Dyspnoea Index (BDI)/Transition Dyspnoea Index (TDI), the effect on health status as determined by the St George Respiratory Questionnaire (SGRQ) and the effect on chronic obstructive pulmonary disease (COPD) exacerbations
Inclusion criteria:
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Exclusion criteria:
Main:
Elizabeth City, North Carolina, United States