Buhl Roland, Gessner Christian, Schuermann Wolfgang, Foerster Karin, Sieder Christian, Hiltl Simone, Korn Stephanie
III.Medizinische Klinik und Poliklinik, Universitätsmedizin der Johannes Gutenberg-Universität Mainz K.d.ö.R., Mainz, Germany.
Universitätsklinikum Leipzig, Leipzig, Germany POIS Leipzig GbR, Leipzig, Germany.
Thorax. 2015 Apr;70(4):311-9. doi: 10.1136/thoraxjnl-2014-206345. Epub 2015 Feb 12.
QVA149 is a once-daily (o.d.) inhaled dual bronchodilator containing a fixed-dose combination of the long-acting β2-agonist indacaterol and the long-acting muscarinic antagonist glycopyrronium for the treatment of COPD. The QUANTIFY study compared QVA149 with a free-dose bronchodilator combination of tiotropium plus formoterol (TIO+FOR) in improving health-related quality of life (HRQoL) of patients with COPD.
This multicentre, blinded, triple-dummy, parallel-group, non-inferiority study randomised patients aged ≥40 years with moderate-to-severe COPD (post-bronchodilator forced expiratory volume in 1 s (FEV1) ≥30% to <80% predicted) to QVA149 110/50 µg o.d. or TIO 18 µg o.d.+ FOR 12 µg twice daily (1:1) for 26 weeks. The primary endpoint was to demonstrate non-inferiority in HRQoL assessed using St George's Respiratory Questionnaire-COPD (SGRQ-C). The prespecified non-inferiority margin was 4 units. Secondary endpoints included Transition Dyspnoea Index (TDI) score, pre-dose FEV1, forced vital capacity (FVC) and safety.
Of the 934 patients randomised (QVA149=476 and TIO+FOR=458), 87.9% completed the study. At week 26, non-inferiority was met for SGRQ-C (QVA149 vs TIO+FOR; difference: -0.69 units; 95% CI -2.31 to 0.92; p=0.399). A significantly higher percentage of patients achieved a clinically relevant ≥1 point improvement in TDI total score with QVA149 (49.6%) versus TIO+FOR (42.4%; p=0.033). QVA149 significantly increased pre-dose FEV1 (+68 mL, 95% CI 37 mL to 100 mL; p<0.001) and FVC (+74 mL, 95% CI 24 mL to 125 mL; p=0.004) compared with TIO+FOR at week 26. The incidence of adverse events was comparable between both treatments (QVA149=43.7% and TIO+FOR=42.6%).
QVA149 is non-inferior to TIO+FOR in improving HRQoL, with clinically meaningful and significant improvements in breathlessness and lung function in patients with COPD.
NCT01120717.
QVA149是一种每日一次吸入用双支气管扩张剂，含有长效β2受体激动剂茚达特罗和长效毒蕈碱拮抗剂格隆溴铵的固定剂量组合，用于治疗慢性阻塞性肺疾病（COPD）。QUANTIFY研究比较了QVA149与噻托溴铵加福莫特罗（TIO+FOR）的自由剂量支气管扩张剂组合在改善COPD患者健康相关生活质量（HRQoL）方面的效果。
这项多中心、双盲、三模拟、平行组、非劣效性研究将年龄≥40岁、中度至重度COPD（支气管扩张剂使用后1秒用力呼气容积（FEV1）≥预计值的30%至<80%）患者随机分为QVA149 110/50μg每日一次组或噻托溴铵18μg每日一次+福莫特罗12μg每日两次组（1:1），治疗26周。主要终点是使用圣乔治呼吸问卷-COPD（SGRQ-C）评估的HRQoL非劣效性。预先设定的非劣效性界值为4分。次要终点包括过渡性呼吸困难指数（TDI）评分、给药前FEV1、用力肺活量（FVC）和安全性。
在934例随机分组的患者中（QVA149组=476例，TIO+FOR组=458例），87.9%完成了研究。在第26周时，SGRQ-C达到非劣效性（QVA149组与TIO+FOR组；差异：-0.69分；95%置信区间-2.31至0.92；p=0.399）。与TIO+FOR组（42.4%；p=0.033）相比，QVA149组有更高比例的患者TDI总分实现了具有临床意义的≥1分改善。与第周26的TIO+FOR组相比，QVA149组给药前FEV1显著增加（+68mL，95%置信区间37mL至100mL；p<0.001），FVC显著增加（+74mL，95%置信区间24mL至125mL；p=0.004）。两种治疗的不良事件发生率相当（QVA149组=43.7%，TIO+FOR组=42.6%）。
在改善HRQoL方面，QVA149不劣于TIO+FOR，对COPD患者的呼吸困难和肺功能有临床意义且显著的改善。
NCT01120717。
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