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. 2018 Jun 19;81(3):198–215. doi: 10.4046/trd.2018.0040

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.