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您的位置:首页 >> 资讯 >> >> 诺华公布COPD新药QVA149 III期SPARK研究详细结果

诺华公布COPD新药QVA149 III期SPARK研究详细结果

http://www.cphi.cn   2013-05-02 15:44 来源:生物谷

    2013年4月23日讯 /生物谷BIOON/ --诺华(Novartis)今天公布了有关QVA149在慢性阻塞性肺病(COPD)患者中的III期SPARK研究的详细结果。研究表明,与格隆(50mcg)及噻托溴铵(18mcg)相比,QVA149能够更有效地减少COPD急性发作。该项研究首次将固定剂量的长效β2-受体激动剂(LABA)和长效毒蕈碱受体拮抗剂(LAMA)组合与单一的LAMA疗法进行疗效比较。相关研究结果已发表于《柳叶刀・呼吸内科》(Lancet Respiratory Medicine)。

    QVA149(马来酸茚达特罗110mcg/格隆50mcg)是一种具双重作用模式的支气管扩张剂,是诺华公司在其Breezhaler单剂量干粉吸入器中的第三个创新药物,该药有望使诺华取代葛兰素史克(GSK)在COPD市场中的领导地位。

    英文原文:Novartis reports detailed results from late-stage COPD study of QVA149

    Basel, April 23, 2013 - Results from the 64-week SPARK study published today in Lancet Respiratory Medicine showed that investigational once-daily dual bronchodilator QVA149 (indacaterol maleate 110 mcg / glycopyrronium 50 mcg) was more effective at reducing all chronic obstructive pulmonary disease (COPD) exacerbations compared to glycopyrronium 50 mcg and open-label (OL) tiotropium 18 mcg a treatment with established efficacy in preventing exacerbations,,,. This is the first study to evaluate the effect on exacerbations of dual bronchodilation with a fixed-dose combination of a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA), versus single LAMA therapies.

    "We are delighted that results from SPARK demonstrated that QVA149 reduced the overall rate of exacerbations in patients with severe and very severe COPD. For physicians and their patients, these findings offer hope of a new effective treatment to prevent debilitating COPD exacerbations and improve health-related quality of life," said Tim Wright, Global Head of Development at Novartis Pharma AG.

    SPARK was a 64-week, multi-center, double-blind, parallel-group, active controlled study with the primary objective to show superiority of QVA149 (indacaterol maleate 110 mcg / glycopyrronium 50 mcg) versus glycopyrronium 50 mcg for the rate of moderate to severe COPD exacerbations in 2,224 patients with severe to very severe COPD. The key secondary objective was to show superiority of QVA149 compared with OL tiotropium 18 mcg with respect to the rate of moderate or severe COPD exacerbations during the treatment period. Patients aged >=40 years with >=1 COPD exacerbation in the year before were randomized to receive either once-daily QVA149, glycopyrronium or OL tiotropium 18 mcg.

    The study met its primary endpoint demonstrating that QVA149 significantly reduced the rate of moderate or severe COPD exacerbations by 12% versus glycopyrronium (p=0.038). The rate of moderate or severe exacerbations was numerically lower (p=0.096) in patients on QVA149 compared to OL tiotropium 18 mcg. The rate of all (mild, moderate, and severe) exacerbations was significantly reduced by 15% with QVA149 compared to glycopyrronium (p=0.0012) and by 14% compared with OL tiotropium 18 mcg (p=0.0017). All treatments had an acceptable safety profile, and there was no meaningful difference between the treatment groups in the incidence of adverse and serious adverse event reporting. Novartis has previously released the First Interpretable Results (FIR) for SPARK.

    SPARK also demonstrated that the dual bronchodilator effect of QVA149 resulted in substantially improved lung function. During the 64-week study, results showed that lung function, as measured by trough FEV1 was significantly higher with QVA149 compared to glycopyrronium (p

    Additionally, QVA149 showed significant differences in health-related quality of life during the study as demonstrated by lower St George`s Respiratory Questionnaire (SGRQ) total scores of QVA149 versus glycopyrronium (p=4 unit) improvement in SGRQ total scores were higher with QVA149 compared to glycopyrronium (p=0.055) or OL tiotropium

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