Clinical role of dual bronchodilation with an indacaterol–glycopyrronium combination in the management of COPD: its impact on patient-related outcomes and quality of life

Figures & data

Table 1 Comparison among studies with QVA149

Study, duration	ARMS	Patients, n	Age, years (mean)	Baseline FEV1 % pr post-BD	Primaryend-point	Secondary end-point	Additional information
					Total AE	Trough FEV1 L
ENLIGHTEN, 6 months	QVA	122	62.5	56.39	57.8	1.607	Less daytime and nighttime symptoms
	Placebo	113	62.9	59.43	56.6	1,418*	–
					Trough FEV1 vs placebo	% of patients with ≥1 TDI	% of patients with ≥ SGRQ
SHINE, 6 months	Placebo	234	64.4	55.2	–	57.5	56.6
	QVA	475	64.0	55.7	+0.200	68.1	63.7
	Indacaterol	477	63.6	54.0	+0.130	64.6	63.0
	Glyco	475	64.3	55.1	+0.120	63.7	60.5
	Tio	483	63.5	55.1	+0.130	59.2	56.4
					FEV1 AUC mL	TDI	SGRQ
ILLUMINATE, 6 months	QVA	258	63.2	51.1	+138	+0.76	−1.24
	SFC	264	63.4	50.7	–	–	–
					Moderate or severe exacerbations	Exacerbation/patient/year	All exacerbations
SPARK, 64 weeks	QVA	741	63.1	37.0	–	0.84	–
	Glyco	741	63.1	37.3	0.88 (Q vs G)*	0.95	0.85 (Q vs G)*
	Tio	742	63.6	37.4	0.90 (Q vs T)	0.88	0.86 (Q vs T)*
					∂ TDI score
BLAZE, 154 days	Three crossover trials: QVA vs placebo vs Tio	246	62.8	56.1	Placebo −0.49, QVA +0.88, Tio +0.39	No AE	–
					Endurance time	Improvement IC
BRIGHT, 105 days	Three crossover trials: QVA vs placebo vs Tio	84	62.1	55.9	No difference	0.19 vs placebo 0.15 vs Tio	No AE
					Non-inferiority on 4 units SQRG	TDI: % of patients improved >1 unit	Post-dose FEV1 least square mean
QUANTIFY, 26 weeks	QVA	476	62.6	53.3	<1 unit	49.6%	+21 mL
	Tio + formoterol	458	63.1	53.0	<1 unit	42.4%	–

Note:

* P<0.05.

Abbreviations: %pr, percent predicted; AE, adverse events; FEV₁, forced expiratory volume in one second; TDI, Transitional Dyspnea Index; SGRQ, St George’s Respiratory Questionnaire; Glyco, glycopyrronium; Tio, tiotropium; SFC, salmeterol–fluticasone combination; AUC, area under the curve. QVA, QVA149 glycopyrronium 50 mcg/Indacaterol 110 mcg; BD, bronchodilator; IC, inspiratory capacity; Q, QVA149; G, glycopyrronium; T, tiotropium.