Table 1.
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 |
od = once-daily; bid = twice-daily.