QVA149 is more efficacious than tiotropium and salmeterol/fluticasone combination (SFC) in improving patient-reported outcomes and lung function in COPD patients with moderate-to-severe baseline dyspnoea: The IGNITE trials

Donald A. Mahler (Lebanon, United States of America), Donald Mahler, Dorothy Keininger, Robert Fogel, Karen Mezzi, Donald Banerji

Source: International Congress 2015 – New data on established treatments for asthma, COPD and bronchiectasis

Session: New data on established treatments for asthma, COPD and bronchiectasis
Session type: Poster Discussion
Number: 2966

Disease area: Airway diseases

Abstract

IntroductionQVA149 is an approved once-daily dual bronchodilator for maintenance treatment of patients with COPD. Here, we assessed the efficacy of QVA149 in improving dyspnoea, health status and lung function in COPD patients with moderate-to-severe baseline dyspnoea (GOLD Group B) from SHINE and ILLUMINATE studies.MethodsSymptomatic patients from SHINE (N=2144) and ILLUMINATE (N=523) studies with baseline dyspnoea index (BDI) £7 (moderate-to-severe dyspnoea equivalent to GOLD Group B) were included in this subgroup analysis. QVA149 was compared to placebo (PBO), open-label tiotropium (TIO), and SFC; TDI, SGRQ and lung function (trough and pre-dose FEV₁) were assessed at Week 26.ResultsMean BDI was comparable in both SHINE [QVA149 (n=305): 5.44, TIO (n=313): 5.57, PBO (n=131): 5.47] and ILLUMINATE [QVA149 (n=166): 5.78, SFC (n=179): 5.85] studies. QVA149 provided significant improvement in dyspnoea and lung function, compared with PBO, TIO and SFC (Table). QVA149 also improved (not significant) SGRQ total score versus SFC.

Table: Treatment differences at Week 26

Parameter	SHINE		ILLUMINATE
	QVA149-PBO	QVA149-TIO	QVA149-SFC
TDI score	1.0(0.3)*¤	0.6(0.2)*	1.0(0.3)*¤
SGRQ score	-2.9(1.3)*	-2.0(1.0)*	-1.4(1.3)
FEV1, mL	200(20)*¤‡	70(16)*‡	100(24)*†

ConclusionIn patients with moderate-to-severe baseline dyspnoea (comparable to GOLD Group B), QVA149 was more efficacious than TIO and SFC in improving patient-reported outcomes and lung function.
Data are least squares mean (standard error); ‡trough and†pre-dose FEV1; ¤clinically meaningful; *p<0.05

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Donald A. Mahler (Lebanon, United States of America), Donald Mahler, Dorothy Keininger, Robert Fogel, Karen Mezzi, Donald Banerji. QVA149 is more efficacious than tiotropium and salmeterol/fluticasone combination (SFC) in improving patient-reported outcomes and lung function in COPD patients with moderate-to-severe baseline dyspnoea: The IGNITE trials. Eur Respir J 2015; 46: Suppl. 59, 2966

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