Once-daily QVA149 improves dyspnoea and health status compared with tiotropium plus formoterol in patients without ICS use: A post-hoc analysis of the QUANTIFY study
Christian Gessner (Leipzig, Germany), Christian Gessner, Wolfgang Schürmann, Karin Förster, Christian Sieder, Simone Hiltl, Roland Buhl, Stephanie Korn
Source: International Congress 2015 – New data on established treatments for asthma and COPD
Session: New data on established treatments for asthma and COPD
Session type: Thematic Poster Session
Number: 1008
Disease area: Airway diseases
Abstract Rationale: The QUANTIFY study compared the approved dual bronchodilator QVA149 with the free-dose combination of tiotropium plus formoterol (TIO+FOR) regarding lung function, dyspnoea and health status in patients with moderate-to-severe COPD. This post-hoc analysis reported on the subgroup of pts without ICS background therapy.Methods: This blinded, triple-dummy 26-week study randomised patients to QVA149 110/50 µg OD or TIO 18 µg OD plus FOR 12 µg b.i.d. (1:1). ICS was allowed as background therapy. Endpoints included lung function (trough FEV1), dyspnoea (TDI) and health status (COPD Assessment Test, CAT).Results: Of the 934 pts randomised (QVA149 [N=476] or TIO+FOR [N=458]); 87.9% completed the study. 41% of all pts had ICS background therapy, but only 2.6% of those were frequent exacerbators. The subgroup of patients without ICS, representing 59% of all pts (QVA 149 [N=275], TIO+FOR [N=274]), showed a statistically significant improvement in breathlessness (least square mean difference (LSMD) in TDI: 0.66; 95% CI: 0.08-1.24 p=0.027), lung function (LSMD trough FEV1: 77 mL, 95% CI: 33-120 mL, p<0.001) and health status (LSMD in CAT: -1.21; 95% CI: -2.10- -0.31, p=0.009). Importantly, for both TDI and CAT, the percentage of patients achieving the minimum clinically important difference was significantly higher with QVA149 versus TIO+FOR (55.6% vs. 45.9%, p=0.026 and 44.9% vs. 33.6%, p=0.007, respectively).Conclusion: QVA149 showed significant improvements in dyspnoea, health status and lung function in the subgroup of patients without ICS use compared with TIO+FOR free-dose combination.
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Christian Gessner (Leipzig, Germany), Christian Gessner, Wolfgang Schürmann, Karin Förster, Christian Sieder, Simone Hiltl, Roland Buhl, Stephanie Korn. Once-daily QVA149 improves dyspnoea and health status compared with tiotropium plus formoterol in patients without ICS use: A post-hoc analysis of the QUANTIFY study. Eur Respir J 2015; 46: Suppl. 59, 1008
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