Table 5. Improvement in health-related quality of life and reduction in rescue medication use with LABA/LAMA FDCs versus placebo, TIO and SFC26,27,28,31,33,35,36,38,40,41,42,43,45,47,48,49,51,53.

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.
SGRQ total score
Placebo	−3.01	−5.51	−4.56 to −4.89	NS to −4.36	NS to −2.52
TIO 18 µg q.d.	−1.7 to −3.1	NS to −2.1	−1.23 to −2.49	NA	NS
SFC 50/500 µg b.i.d.	NS to −1.3	NS	NA	NS	NA
Proportion of patients achieving MCID for SGRQ total score (odds ratio)
Placebo	NS	2	2.2–2.5	2.3	NS to 1.49
TIO 18 µg q.d.	NS to 1.48†	NS to 1.4	1.43 to 1.58	NA	NS
SFC 50/500 µg b.i.d.	NS to 1.30	NA	NA	NR‡	NA
Rescue medication use (puffs/day)
Placebo	−0.73 to −1.43	−0.8	NA	−0.66; NR§	−1.04 to −1.08
TIO 18 µg q.d.	−0.45 to −1.08	−0.5 to −0.7	−0.55¶	NA	−0.34 to −0.51
SFC 50/500 µg b.i.d.	NS to −0.39	NS to −0.3	NA	NA	NA

Data expressed as minimum and maximum mean value from all trials analyzed.

^*For OLO/TIO 5/5 µg q.d. studies, TIO 5 µg q.d. used as comparator. ^†Differences were statistically significant at all time points up to Week 52 (at week 64, p=0.051). ^‡52.6% patients in FOR/ACLI arm and 55.8% in SFC arm achieved MCID for SGRQ total score. ^§Significant reductions in the use of rescue medication versus placebo were also observed in the AUGMENT study (puffs/day not reported). ^¶Approximate value.

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; SGRQ: St. George's Respiratory Questionnaire; NS: non-significant; NA: not available (no outcomes in any of the trials evaluated); MCID: minimum clinically important difference; NR: not reported (outcomes not reported in required units).