Study | Design | Treatment arms | Number of patients | Treatment duration |
---|---|---|---|---|
Donohue [5] | Phase III, randomized, double-blind (indacaterol and placebo) or open-label (tiotropium), placebo-controlled, parallel-group, multicentre | Indacaterol 150 μg od | 1683 randomized; | 26 weeks |
Indacaterol 300 μg od | 1665 evaluable for efficacy | |||
Tiotropium 18 μg od | ||||
Placebo | ||||
Dahl [6] | Phase III, randomized, double-blind, double-dummy, placebo-controlled, parallel-group, multicentre | Indacaterol 300 μg od | 1732 randomized; | 52 weeks |
Indacaterol 600 μg od | 1600 evaluable for efficacy | |||
Formoterol 12 μg bid | ||||
Placebo | ||||
Kornmann [7] | Phase III, randomized, double-blind, double-dummy, placebo-controlled, parallel-group, multicentre | Indacaterol 150 μg od | 1002 randomized; | 26 weeks |
Salmeterol 50 μg bid | 998 evaluable for efficacy | |||
Placebo | ||||
Gotfried-1 [8] | Phase III, randomized, double-blind, placebo-controlled, parallel-group, in the United States | Indacaterol 75 μg od | 323 randomized; | 12 weeks |
Placebo | 323 evaluable for efficacy | |||
Gotfried-2 [8] | Phase III, randomized, double-blind, placebo-controlled, parallel-group, in the United States | Indacaterol 75 μg od | 318 randomized; | 12 weeks |
Placebo | 317 evaluable for efficacy | |||
Kinoshita [9] | Phase III, randomized, double-blind, placebo-controlled, parallel-group, in six Asian areas | Indacaterol 150 μg od | 347 randomized; | 12 weeks |
Indacaterol 300 μg od | 347 evaluable for efficacy | |||
Placebo |