A 12 Week Study of QVA149 Compared to Fluticasone/Salmeterol (Advair) for Treatment of COPD

Trough Forced Expiratory Volume in 1 second (FEV1) following 12 weeks of treatment

Spiromtery testing conducted according to internationally accepted standards. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The trough FEV1 will be will be defined as the mean from repeat measurements at Day 1 and week 12

Time frame: Day 1 and Week 12

Peak Forced Expiratory Volume in 1 second (FEV1) within 4 hours post-dose

Spirometry testing conducted accorded to internationally accepted standards. Peak FEV1 defined as the maximum FEV1 during the first 4 hours post dosing. The Peak FEV1 will be defined as the mean from repeat measurements at Day 1 and week 12.

Time frame: Day 1 and Week 12

Area under the curve (AUC) 0-4 hours for FEV1

Area under the curve (AUC) 0-4 hours for Forced Expiratory Volume in 1 second (FEV1) at Day 1 and week 12. AUC will be calculated using the trapezoidal rule and standardized with respect to length of time from the first 5 minute to the last measurement at 12 hours.

Time frame: Day 1 and Week 12

Transition Dyspnea Index (TDI) Focal Score

Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline; negative scores indicate deterioration. A TDI focal score of 1 unit is considered to be a minimal clinically important difference (MCID) from baseline.