Table 3. Improvement in lung function with LABA/LAMA FDCs versus placebo, TIO and SFC26,27,28,31,32,33,35,36,38,40,41,42,43,44,45,46,47,48,49,50,51,53,55.
Variable | IND/GLY 110/50 µg q.d. | VI/UMEC 25/62.5 µg q.d. | OLO/TIO 5/5 µg q.d.* | FOR/ACLI 12/400 µg b.i.d. | FF/GP 9.6/18 µg b.i.d. |
---|---|---|---|---|---|
Trough FEV1, mL | |||||
Placebo | 189 to 200 | 167 | 162 to 208 | 129 to 143 | 103 to 150 |
TIO 18 µg q.d. | 60 to 100 | 60 to 112 | NS to 79 | NA | NS to 25 |
SFC 50/500 µg b.i.d. | 62 to 103 | 82 to 98 | 58 | NS | NA |
Peak FEV1, mL | |||||
Placebo | 330 | 224 | 323 to 339 | 285 to 334 | 267 to 291 |
TIO 18 µg q.d. | 130 | 72 to 95 | 111 to 135 | NA | 93 to 97 |
SFC 50/500 µg b.i.d. | 121 to 155 | 97 to 122 | 147 | 93 | NA |
FEV1 5-min post morning dose, study end, mL | |||||
Placebo | 290 | 112† | NA | 108 to 128 | 186‡ to 187‡ |
TIO 18 µg q.d. | 94 to 120 | NA | NA | NA | NA |
SFC 50/500 µg b.i.d. | 150 | NA | NA | NA | NA |
FEV1 AUC0–xh | |||||
Placebo | 320§ to 330¶ | 242∥ | 280§ to 331** | 221†† | NA |
TIO 18 µg q.d. | 110¶ | 74∥ to 105∥ | 103** to 117** | NA | NA |
SFC 50/500 µg b.i.d. | 110†† to 138†† | 74∥ to 101∥ | 86 | 90 | NA |
Values are presesnted as minimum and maximum mean LSM treatment difference value from all trials analyzed.
*For OLO/TIO 5/5 µg q.d. studies, TIO 5 µg q.d. used as comparator. †FEV1 15-min post morning dose on day 1. ‡FEV1 5-min post morning dose, day 1. §FEV1 AUC0–24h. ¶FEV1 AUC0–4h. ∥FEV1 AUC0–6h. **FEV1AUC0–3h. ††FEV1 AUC0–12h.
LABA/LAMA: long-acting β2-agonist/long-acting muscarinic antagonist; FDC: fixed-dose combination; TIO: tiotropium; SFC: salmeterol/fluticasone; IND/GLY: indacaterol/glycopyrronium; q.d.: once daily; VI/UMEC: vilanterol/umeclidinium; OLO/TIO: olodaterol/tiotropium; FOR/ACLI: formoterol/aclidinium; b.i.d.: twice daily; FF/GP: formoterol fumarate/glycopyrrolate; FEV1: forced expiratory volume in 1 second; NS: non-significant; NA: not available (no outcomes in any of the trials evaluated); AUC: area under the curve.