Table 1. Study designs.

NCT number	Study	Study objective	Study design	Duration/endpoint	No. of patients randomized	Treatments
NCT00463567	INHANCE (49)	Efficacy/safety in target population in stage 2 of the study	Multicenter, randomized, double-blind, double-dummy, placebo-controlled, adaptive, seamless, parallel-group study	26 weeks/trough FEV1 at week 12, indacaterol 150 and/or 300 µg vs. placebo	1,683	Indacaterol 150 µg once daily;
						Indacaterol 300 µg once daily;
						Tiotropium 18 µg open-label once daily;
						Placebo
NCT00677807	INDORSE (50)	Safety/tolerability/efficacy	Multicenter, randomized, double-blind, placebo-controlled, adaptive, seamless parallel-group study	26 weeks extension of B2335S/safety profile over 52 weeks	415	Indacaterol 150 µg once daily;
						Indacaterol 300 µg once daily;
						Placebo
NCT00567996	INLIGHT-2 (51)	Efficacy/safety	Multicenter, randomized, double-blind, double- dummy, placebo-controlled, parallel-group study	26 weeks/trough FEV1 at week 12, indacaterol 150 µg vs. placebo	1,002	Indacaterol 150 µg once daily;
						Salmeterol 50 µg twice daily;
						Placebo
NCT00624286	INLIGHT-1 (52)	Efficacy/safety	Multicenter, randomized, double-blind, placebo-controlled, parallel-group study	12 weeks/trough FEV1 at week 12, indacaterol 150 µg vs. placebo	416	Indacaterol 150 µg once daily;
						Placebo
NCT00821093	INSIST (53)	Efficacy/safety	Multicenter, randomized, parallel-group, double-blind, double dummy study	12 weeks/FEV1 AUC5 min-11 h 45 min at week 12, indacaterol 150 µg vs. salmeterol 50 µg	1,123	Indacaterol 150 µg once daily;
						Salmeterol 50 µg twice daily
NCT00900731	INTENSITY (54)	Efficacy/safety	Multicenter, randomized, parallel-group, blinded, double-dummy study	12 weeks/trough FEV1 at week 12, indacaterol 150 µg vs. tiotropium 18 µg (non inferiority)	1,598	Indacaterol 150 µg once daily;
						Tiotropium 18 µg once daily
NCT00846586	INTRUST-1 (55)	Efficacy/safety	Randomized, double blind	12 weeks/FEV1 AUC5 min-8 h at week 12, indacaterol 150 µg plus tiotropium 18 µg vs. tiotropium 18 µg	1,134	Indacaterol 150 µg once daily plus tiotropium 18 µg once daily;
						Tiotropium 18 µg once daily plus placebo
NCT00877383	INTRUST-2 (55)	Efficacy/safety	Randomized, double-blind	12 weeks FEV1 AUC5 min-8 h at week 12, indacaterol 150 µg plus tiotropium 18 µg vs. tiotropium 18 µg	1,142	Indacaterol 150 µg once daily plus tiotropium 18 µg once daily;
						Tiotropium 18 µg once daily plus placebo
NCT00794157	B1302 (56)	Efficacy/safety/tolerability	Multicenter, randomized, double-blind, placebo-controlled, parallel-group study	12 weeks/trough FEV1 at week 12, indacaterol 150 and/or 300 µg vs. placebo	347	Indacaterol 150 µg once daily;
						Indacaterol 300 µg once daily;
						Placebo
NCT00792805	B2333 (57)	Efficacy/safety	Multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group study	26 weeks/trough FEV1 at week 12, indacaterol 150 and/or 300 µg vs. placebo	563	Indacaterol 150 µg once daily;
						Indacaterol 300 µg once daily;
						Placebo

AUC, area under the curve; FEV₁, forced expiratory volume in 1 sec.