Table 1.
Pivotal trials of 12 weeks in duration or longer
| Reference | Study | Severity of COPD | Study duration (weeks) | Treatment arms |
|---|---|---|---|---|
| Feldman et al13 | B2346, INLIGHT1 | Moderate to severe | 12 | IND 150 μg (n = 211) Placebo (n = 205) |
| Kornmann et al14 | B2336, INLIGHT2 | Moderate to severe | 26 | IND 150 μg (n = 330) SAL 50 μg BID (n = 334) Placebo (n = 335) |
| Dahl et al15 | B2334, INVOLVE | Moderate to severe | 52 | IND 300 (n = 437) or 600 μg (n = 428) FOR 12 μg BID (n = 435) Placebo (n = 432) |
| Donohue et al16 | B2335S, INHANCE | Moderate to severe | 26 | IND 150 (n = 416) or 300 μg (n = 416) Placebo (n = 418) Open-label TIO 18 μg (n = 415) |
| Buhl et al17 | B2350, INTENSITY | Moderate to severe | 12 | IND 150 μg (n = 794) TIO 18 μg (n = 799) |
| Korn et al18 | B2349, INSIST | Moderate to severe | 12 | IND 150 μg (n = 559) SAL 50 μg BID (n = 562) |
| Chapman et al19 | Study 2335SE, INDORSE (extension of INHANCE) |
Moderate to severe | Additional 26 (total 52) |
IND 150 or 300 μg Placebo (n = 415) |
Abbreviations: BID, twice daily; COPD, chronic obstructive pulmonary disease; FOR, formoterol; IND, indacaterol; SAL, salmeterol; TIO, tiotropium.