Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Randomised, Double-blind, Double-dummy, Crossover Efficacy and Safety Comparison of 6-week Treatment Periods of the Free Combinations of Tiotropium Inhalation Powder Capsule (18 μg) QD + Salmeterol Metered Dose Inhaler (2 Puffs of 25 μg) QD or BID, Tiotropium Inhalation Powder Capsule (18 μg) QD and Salmeterol Metered Dose Inhaler (2 Puffs of 25 μg) BID in Patients With (COPD)
Main Study: To evaluate and to compare the lung function response to the free combinations
of tiotropium 18 μg (QD) + salmeterol 50 μg (QD or BID), salmeterol 50 μg BID and tiotropium
18 μg QD at the end of 6-week treatment periods in patients with COPD.
Sub-Study: Was performed in subset of patients participating in the Main Study to assess the
effect of the four randomised treatments on dynamic hyperinflation.
Extension Study: To establish whether the FEV1 time profile following combination
bronchodilator therapy of tiotropium plus salmeterol is affected by the pharmaceutical
formulation of salmeterol, i.e. the MDI or the Diskus®.
n/a
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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