Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Spirometry COPD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 342
Healthy volunteers: no

Brief summary:
The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) in patients with COPD.

SPIRIVA® and HANDIHALER® are trade marks of Boehringer Ingelheim Pharma GmbH \& Co. KG.

ADVAIR DISKUS® are registered trademarks of the GSK group of companies.

Detailed description:

Arms:
arm 1: Fluticasone Propionate/Salmeterol Combination Product 250/50mcg BID Plus Tiotropium Bromide 18 mcg QD arm 2: Tiotropium Bromide 18mcg QD plus Placebo DISKUS BID

Interventions: intervention 1: Tiotropium Bromide intervention 2: Fluticasone Propionate/Salmeterol
Intervention descriptions: intervention 1: Long-acting muscarinic antagonist intervention 2: Inhaled corticosteroid plus long-acting bronchodilator

Protocol document: