雾化Ensifentrine治疗慢性阻塞性肺疾病(COPD):即将开展III期临床试验

2020-09-28 Allan MedSci原创

Verona Pharma已启动一项III期临床试验(ENHANCE研究),以评估雾化Ensifentrine治疗中度至重度慢性阻塞性肺疾病(COPD)的安全性和有效性。

Verona Pharma已启动一项III期临床试验(ENHANCE研究),以评估雾化Ensifentrine治疗中度至重度慢性阻塞性肺疾病(COPD)的安全性和有效性。

这项临床试验将在美国和欧盟招募约800名中至重度有症状的COPD患者。主要终点是肺功能的改善–通过Ensifentrine治疗12周后一秒钟的呼气量(FEV1)来衡量。次要终点包括COPD症状的改善和患者生活质量的改善。

Verona制药公司总裁兼首席执行官David Zaccardelli说:“我们很高兴开始进行关键的ENHANCE研究。如果成功,这些数据将支持在美国提交新药申请”。他补充说:“对于Verona制药公司而言,这是一个重要的里程碑,我们期待着解决COPD对新型治疗手段的迫切需求”。

Ensifentrine是一种将支气管扩张剂和抗炎活性结合在一起的化合物。在先前COPD的临床研究中,该疗法作为单一疗法或与维持性支气管扩张药联合使用时,能够显著改善肺功能、症状和生活质量。

 

原始出处:

http://www.pharmatimes.com/news/verona_pharma_launches_late-stage_copd_trial_programme_1351157

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encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Thu Jun 03 00:08:00 CST 2021, time=2021-06-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1785686, encodeId=982c1e85686d7, content=<a href='/topic/show?id=4a82680e6f' target=_blank style='color:#2F92EE;'>#ensifentrine#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6807, encryptionId=4a82680e6f, topicName=ensifentrine)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d47b2500175, createdName=12498cf9m35(暂无昵称), createdTime=Tue Apr 20 15:08:00 CST 2021, time=2021-04-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1696954, encodeId=3f8e16969547d, content=<a href='/topic/show?id=d2e99e651e4' target=_blank style='color:#2F92EE;'>#阻塞#</a>, beContent=null, 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02:08:00 CST 2020, time=2020-09-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1588060, encodeId=3d271588060ad, content=<a href='/topic/show?id=056095e171' target=_blank style='color:#2F92EE;'>#III期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9571, encryptionId=056095e171, topicName=III期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d24217580122, createdName=guihongzh, createdTime=Wed Sep 30 02:08:00 CST 2020, time=2020-09-30, status=1, ipAttribution=)]
    2021-06-03 juliusluan78
  5. 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02:08:00 CST 2020, time=2020-09-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1588060, encodeId=3d271588060ad, content=<a href='/topic/show?id=056095e171' target=_blank style='color:#2F92EE;'>#III期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9571, encryptionId=056095e171, topicName=III期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d24217580122, createdName=guihongzh, createdTime=Wed Sep 30 02:08:00 CST 2020, time=2020-09-30, status=1, ipAttribution=)]
  6. 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02:08:00 CST 2020, time=2020-09-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1588060, encodeId=3d271588060ad, content=<a href='/topic/show?id=056095e171' target=_blank style='color:#2F92EE;'>#III期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9571, encryptionId=056095e171, topicName=III期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d24217580122, createdName=guihongzh, createdTime=Wed Sep 30 02:08:00 CST 2020, time=2020-09-30, status=1, ipAttribution=)]
    2020-10-24 仁医06
  7. 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心力衰竭(HF)和慢性阻塞性肺病(COPD)在老年人中往往得不到诊断,尽管这两种疾病都会抑制功能和损害健康。该研究旨在评估这些疾病的病例调查策略的有效性。

Medicine:复方草石蚕颗粒可通过改变肠道微生物群来改善COPD患者的症状

慢性阻塞性肺疾病(COPD)患者通常会反复出现急性发作。这些患者,尤其是病情稳定的COPD患者,需要一种有效的干预措施来治疗发作。本研究旨在评价复方草石蚕颗粒(CCSG)对稳定型COPD患者的疗效,并

Eur Respir J:COPD患者FEV1加速下降与心血管疾病和死亡风险的关系

CVD结局和死亡率与发作频率和严重程度以及mMRC呼吸困难增加有关,但与FEV1加速下降无关。

Eur Respir J:COPD患者使用ICS与骨质疏松和骨折风险的关系

COPD患者发生骨折和骨质疏松症的风险更大,使用大剂量ICS会进一步增加这种风险。

三联疗法Breztri Aerosphere显著降低中重度COPD急性发作率

III期临床试验(ETHOS研究)表明,与双联疗法相比,阿斯利康的三联疗法Breztri Aerosphere(布地奈德/吡喃糖/富马酸福莫特罗)显著降低了慢性阻塞性肺疾病(COPD)的急性发作率。

拓展阅读

GSK与Theravance携手开发新COPD药物

制药巨头葛兰素史克公司与Theravance公司最近宣布双方将合作开发治疗慢性阻塞性肺炎的新药物。这种药物将结合目前已经上市的Breo Ellipta和Anoro Ellipta两种药物的有效成分。研究人员计划这一新型药物将会以每日一次的吸入喷雾剂形式出现。研究计划还包括招募10000名患者参与早期研究,以确定上述两种药物联用是否能更好治疗慢性阻塞性肺炎。研究人员介绍说,目前慢性阻塞性肺炎患者

森林实验室(Forest Lab) COPD药物Aclidinium获FDA批准

Forest Lab公司吸入性药物Aclidinium(商品名Tudorza Pressair)获FDA批准用于治疗吸烟者的咳嗽,即通常所称的慢性阻塞性肺病(COPD)。该药的获批巩固了该公司通过新产品来增加利润的计划。 Tudorza Pressair为日服2次的药物,由Forest与西班牙Almiral SA公司合作开发,用于放松肺部肌肉以改善气流,不久将在美国上市。 COPD在美国是第4