A 24-Week Study to Evaluate the Safety and Efficacy of ADVAIR DISKUS® Inhaler 250/50mcg Plus SPIRIVA HANDIHALER® Inhaler Versus SPIRIVA HANDIHALER® Inhaler Plus Placebo DISKUS® Inhaler in Subjects With Chronic Obstructive Pulmonary Disease (COPD).

A Randomized, Double-Blind, Parallel-Group, 24-Week Study to Evaluate the Efficacy and Safety of ADVAIR DISKUS (Fluticasone Propionate/Salmeterol Combination Product 250/50mcg Inhalation Powder) BID Plus Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder 18mcg) QD Versus Spiriva QD Plus Placebo DISKUS BID in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

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.

Inclusion Criteria:

• COPD diagnosis
• At least 10 pack year smoking history
• Post-albuterol FEV1 greater than or equal to 40% to less than or equal to 80% of predicted normal
• An FEV1/FVC ratio of less than or equal to 0.70

Exclusion Criteria:

• Current diagnosis of asthma
• Other respiratory disorder other than COPD
• Abnormal and clinical significant ECG
• Chest x-ray clinically significant abnormality not believed to be due to COPD
• Body Mass Index of greater than or equal to 40/kg/m2
• Use of Long Term Oxygen Therapy
• Lung resection surgery
• Women pregnant or lactating at Visit 1
• Previously diagnosed cancer unless in complete remission for 2 years at Visit 1