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哮喘高强度与 Ics/Laba hs 和 tiotRopium 的三联（TRIGGER） (TRIGGER)

2026年6月2日 更新者：Chiesi Farmaceutici S.p.A.

一项为期 52 周、随机、双盲、多国家、多中心、主动控制的 3 臂平行组试验比较 CHF 5993 200/6/12.5 µg pMDI（特级倍氯米松二丙酸酯的固定组合加福莫特罗加富马酸盐加福莫特罗加 CHF0205 乙二胺嘧啶的固定组合） /6 µg pMDI（特级双丙酸倍氯米松加富马酸福莫特罗的固定组合）单独使用或在开放标签噻托溴铵 2.5 µg RESPIMAT® 的基础上与长效 ß2-激动剂联合使用大剂量吸入皮质类固醇后仍无法控制的哮喘患者

本研究的目的是评估 CHF 5993 200/6/12.5 的优越性 µg pMDI（特级倍氯米松二丙酸盐加福莫特罗富马酸盐加格隆溴铵的固定组合）与 CHF 1535 200/6 µg pMDI（特级倍氯米松二丙酸盐加福莫特罗富马酸盐的固定组合）并比较 CHF 5993 200/6/12.5 的效果 µg pMDI 对比 CHF 5993 200/6/12.5 µg 加开放标签噻托溴铵 2.5µg，在肺功能参数和恶化率方面，以及评估其安全性和一些健康经济学结果。

研究概览

地位

完全的

条件

干预/治疗

详细说明

This was a phase III, multicentre, randomised, double-blind study, with an open-label arm, active-controlled, 3-arm parallel group study to demonstrate both the superiority of CHF 5993 pMDI 200/6/12.5 μg compared with CHF 1535 pMDI 200/6 μg in terms of change from baseline in pre-dose FEV1 at Week 26 and a reduction of moderate and severe asthma exacerbation rate with CHF 5993 pMDI 200/6/12.5 μg compared to CHF 1535 pMDI 200/6 μg during the entire 52-week treatment period.

The study was performed in patients with uncontrolled asthma on high doses of inhaled corticosteroids (ICS) in combination with long acting β2-agonists LABAs). The study was conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and all other requirements of local laws.

Patients completed the electronic diary (eDiary)/electronic peak flow meter (ePeakflowmeter) twice daily at home from screening to Week 52, recording asthma symptoms, treatment compliance, rescue intake and peak expiratory flow (PEF). The Asthma Control Questionnaire© (ACQ)-7 was completed at all visits from screening to Week 52. The EuroQuality of Life-5-Dimensional-3-Level (EQ-5D-3L™) questionnaire was completed at all visits from randomisation to Week 52. Health economic information was collected during the study. An independent Data Safety Monitoring Board was established for evaluation of the study and impartial safety assurance for patients. An Adjudication Committee was established to evaluate Major Adverse Cardiovascular Events.

Primary objective of the study were:

  • To demonstrate the superiority of CHF 5993 pMDI 200/6/12.5 μg compared with CHF 1535 pMDI 200/6 μg in terms of change from baseline in pre-dose forced expiratory volume in the 1st second (FEV1) at Week 26;
  • To demonstrate the reduction of moderate and severe asthma exacerbations rate with CHF 5993 pMDI 200/6/12.5 μg compared with CHF 1535 pMDI 200/6 μg during the entire 52-week treatment period.

The secondary endpoints included pooled analyse of 2 pivotal studies; this study (TRIGGER) and study (TRIMARAN). These 2 studies have similar study designs and study population.

CHF 1535 pMDI: fixed-dose combination (FDC) of BDP + FF + GB Dose: BDP 200 μg, FF 6 μg, GB 12.5 μg per actuation, 2 inhalations, BID. Total daily dose: BDP 800 μg, FF 24 μg, GB 50 μg.

BDP: Beclometasone dipropionate FF: Formoterol fumarate GB: Glycopyrronium bromide

研究类型

介入性

注册 (实际的)

1437

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 乌克兰
      • Dnipro、乌克兰
        • Chiesi Clinical Trial Site 804701
      • Ivano-Frankivsk、乌克兰
        • Chiesi Clinical Trial Site 804711
      • Kharkiv、乌克兰
        • Chiesi Clinical Trial Site 804709
      • Kherson、乌克兰
        • Chiesi Clinical Trial Site 804710
      • Kiev、乌克兰
        • Chiesi Clinical Trial Site 804713
      • Kyiv、乌克兰
        • Chiesi Clinical Trial Site 804705
      • Lviv、乌克兰
        • Chiesi Clinical Trial Site 804712
      • Sumy、乌克兰
        • Chiesi Clinical Trial Site 804715
      • Vinnytsia、乌克兰
        • Chiesi Clinical Trial Site 804703
      • Vinnytsia、乌克兰
        • Chiesi Clinical Trial Site 804706
      • Vinnytsia、乌克兰
        • Chiesi Clinical Trial Site 804707
      • Vinnytsia、乌克兰
        • Chiesi Clinical Trial Site 804714
      • Zaporizhzhya、乌克兰
        • Chiesi Clinical Trial Site 804704
      • Zhytomyr、乌克兰
        • Chiesi Clinical Trial Site 804708
  • 俄罗斯
      • Chelyabinsk、俄罗斯
        • Chiesi Clinical Trial Site 643727
      • Chelyabinsk、俄罗斯
        • Chiesi Clinical Trial Site 643733
      • Chelyabinsk、俄罗斯
        • Chiesi Clinical Trial Site 643745
      • Izhevsk、俄罗斯
        • Chiesi Clinical Trial Site 643754
      • Kazan'、俄罗斯
        • Chiesi Clinical Trial Site 643713
      • Kazan'、俄罗斯
        • Chiesi Clinical Trial Site 643719
      • Kazan'、俄罗斯
        • Chiesi Clinical Trial Site 643741
      • Kazan'、俄罗斯
        • Chiesi Clinical Trial Site 643746
      • Kemerovo、俄罗斯
        • Chiesi Clinical Trial Site 643704
      • Kemerovo、俄罗斯
        • Chiesi Clinical Trial Site 643731
      • Moscow、俄罗斯
        • Chiesi Clinical Trial Site 643702
      • Moscow、俄罗斯
        • Chiesi Clinical Trial Site 643705
      • Moscow、俄罗斯
        • Chiesi Clinical Trial Site 643706
      • Moscow、俄罗斯
        • Chiesi Clinical Trial Site 643718
      • Moscow、俄罗斯
        • Chiesi Clinical Trial Site 643722
      • Moscow、俄罗斯
        • Chiesi Clinical Trial Site 643735
      • Moscow、俄罗斯
        • Chiesi Clinical Trial Site 643743
      • Nizhny Novgorod、俄罗斯
        • Chiesi Clinical Trial Site 643707
      • Nizhny Novgorod、俄罗斯
        • Chiesi Clinical Trial Site 643723
      • Nizhny Novgorod、俄罗斯
        • Chiesi Clinical Trial Site 643744
      • Novosibirsk、俄罗斯
        • Chiesi Clinical Trial Site 643717
      • Odintsovo、俄罗斯
        • Chiesi Clinical Trial Site 643724
      • Orenburg、俄罗斯
        • Chiesi Clinical Trial Site 643729
      • Pyatigorsk、俄罗斯
        • Chiesi Clinical Trial Site 643711
      • Ryazan、俄罗斯
        • Chiesi Clinical Trial Site 643701
      • Saint Petersburg、俄罗斯
        • Chiesi Clinical Trial Site 643712
      • Saint Petersburg、俄罗斯
        • Chiesi Clinical Trial Site 643714
      • Saint Petersburg、俄罗斯
        • Chiesi Clinical Trial Site 643715
      • Saint Petersburg、俄罗斯
        • Chiesi Clinical Trial Site 643716
      • Saint Petersburg、俄罗斯
        • Chiesi Clinical Trial Site 643725
      • Saint Petersburg、俄罗斯
        • Chiesi Clinical Trial Site 643730
      • Saint Petersburg、俄罗斯
        • Chiesi Clinical Trial Site 643732
      • Saint Petersburg、俄罗斯
        • Chiesi Clinical Trial Site 643737
      • Saint Petersburg、俄罗斯
        • Chiesi Clinical Trial Site 643739
      • Saint Petersburg、俄罗斯
        • Chiesi Clinical Trial Site 643752
      • Saint Petersburg、俄罗斯
        • Chiesi Clinical Trial Site 643757
      • Saint Petersburg、俄罗斯
        • Chiesi Clinical Trial Site 643758
      • Saratov、俄罗斯
        • Chiesi Clinical Trial Site 643703
      • Saratov、俄罗斯
        • Chiesi Clinical Trial Site 643736
      • Smolensk、俄罗斯
        • Chiesi Clinical Trial Site 643726
      • Stavropol、俄罗斯
        • Chiesi Clinical Trial Site 643740
      • Tomsk、俄罗斯
        • Chiesi Clinical Trial Site 643709
      • Tomsk、俄罗斯
        • Chiesi Clinical Trial Site 643728
      • Tomsk、俄罗斯
        • Chiesi Clinical Trial Site 643759
      • Ufa、俄罗斯
        • Chiesi Clinical Trial Site 643755
      • Vladikavkaz、俄罗斯
        • Chiesi Clinical Trial Site 643708
      • Vladimir、俄罗斯
        • Chiesi Clinical Trial Site 643738
      • Voronezh、俄罗斯
        • Chiesi Clinical Trial Site 643710
      • Yaroslavl、俄罗斯
        • Chiesi Clinical Trial Site 643720
      • Yaroslavl、俄罗斯
        • Chiesi Clinical Trial Site 643734
      • Yaroslavl、俄罗斯
        • Chiesi Clinical Trial Site 643742
      • Yaroslavl、俄罗斯
        • Chiesi Clinical Trial Site 643749
      • Yekaterinburg、俄罗斯
        • Chiesi Clinical Trial Site 643721
  • 保加利亚
      • Blagoevgrad、保加利亚
        • Chiesi Clinical Trial Site 100707
      • Burgas、保加利亚
        • Chiesi Clinical Trial Site 100720
      • Gabrovo、保加利亚
        • Chiesi Clinical Trial Site 100718
      • Haskovo、保加利亚
        • Chiesi Clinical Trial Site 100713
      • Montana、保加利亚
        • Chiesi Clinical Trial Site 100722
      • Pleven、保加利亚
        • Chiesi Clinical Trial Site 100702
      • Plovdiv、保加利亚
        • Chiesi Clinical Trial Site 100705
      • Plovdiv、保加利亚
        • Chiesi Clinical Trial Site 100708
      • Plovdiv、保加利亚
        • Chiesi Clinical Trial Site 100715
      • Rousse、保加利亚
        • Chiesi Clinical Trial Site 100716
      • Sofia、保加利亚
        • Chiesi Clinical Trial Site 100701
      • Sofia、保加利亚
        • Chiesi Clinical Trial Site 100703
      • Sofia、保加利亚
        • Chiesi Clinical Trial Site 100704
      • Sofia、保加利亚
        • Chiesi Clinical Trial Site 100709
      • Sofia、保加利亚
        • Chiesi Clinical Trial Site 100719
      • Stara Zagora、保加利亚
        • Chiesi Clinical Trial Site 100706
      • Stara Zagora、保加利亚
        • Chiesi Clinical Trial Site 100712
      • Varna、保加利亚
        • Chiesi Clinical Trial Site 100710
      • Vidin、保加利亚
        • Chiesi Clinical Trial Site 100711
      • Vidin、保加利亚
        • Chiesi Clinical Trial Site 100721
  • 匈牙利
      • Balassagyarmat、匈牙利
        • Chiesi Clinical Trial Site 348707
      • Budapest、匈牙利
        • Chiesi Clinical Trial Site 348715
      • Debrecen、匈牙利
        • Chiesi Clinical Trial Site 348721
      • Gödöllő、匈牙利
        • Chiesi Clinical Trial Site 348712
      • Hatvan、匈牙利
        • Chiesi Clinical Trial Site 348718
      • Komárom、匈牙利
        • Chiesi Clinical Trial Site 348717
      • Létavértes、匈牙利
        • Chiesi Clinical Trial Site 348709
      • Monor、匈牙利
        • Chiesi Clinical Trial Site 348703
      • Mórahalom、匈牙利
        • Chiesi Clinical Trial Site 348719
      • Nyíregyháza、匈牙利
        • Chiesi Clinical Trial Site 348704
      • Nyíregyháza、匈牙利
        • Chiesi Clinical Trial Site 348714
      • Pécs、匈牙利
        • Chiesi Clinical Trial Site 348713
      • Pécs、匈牙利
        • Chiesi Clinical Trial Site 348720
      • Siófok、匈牙利
        • Chiesi Clinical Trial Site 348702
      • Szarvas、匈牙利
        • Chiesi Clinical Trial Site 348706
      • Szeged、匈牙利
        • Chiesi Clinical Trial Site 348701
      • Szombathely、匈牙利
        • Chiesi Clinical Trial Site 348705
      • Vásárosnamény、匈牙利
        • Chiesi Clinical Trial Site 348710
      • Érd、匈牙利
        • Chiesi Clinical Trial Site 348708
  • 土耳其（türkiye）
      • Ankara、土耳其（türkiye）
        • Chiesi Clinical Trial Site 792701
      • Ankara、土耳其（türkiye）
        • Chiesi Clinical Trial Site 792702
      • Antalya、土耳其（türkiye）
        • Chiesi Clinical Trial Site 792703
      • Aydin、土耳其（türkiye）
        • Chiesi Clinical Trial Site 792710
      • Istanbul、土耳其（türkiye）
        • Chiesi Clinical Trial Site 792707
      • Kocaeli、土耳其（türkiye）
        • Chiesi Clinical Trial Site 792706
      • Maltepe、土耳其（türkiye）
        • Chiesi Clinical Trial Site 792705
      • Mersin、土耳其（türkiye）
        • Chiesi Clinical Trial Site 792708
      • Yenişehir、土耳其（türkiye）
        • Chiesi Clinical Trial Site 792709
  • 德国
      • Berlin、德国
        • Chiesi Clinical Trial Site 276709
      • Berlin、德国
        • Chiesi Clinical Trial Site 276712
      • Bonn、德国
        • Chiesi Clinical Trial Site 276711
      • Frankfurt am Main、德国
        • Chiesi Clinical Trial Site 276707
      • Frankfurt am Main、德国
        • Chiesi Clinical Trial Site 276714
      • Hamburg、德国
        • Chiesi Clinical Trial Site 276705
      • Hanover、德国
        • Chiesi Clinical Trial Site 276703
      • Koblenz、德国
        • Chiesi Clinical Trial Site 276708
      • Leipzig、德国
        • Chiesi Clinical Trial Site 276702
      • Leipzig、德国
        • Chiesi Clinical Trial Site 276704
      • Leipzig、德国
        • Chiesi Clinical Trial Site 276710
      • Mainz、德国
        • Chiesi Clinical Trial Site 276715
      • München、德国
        • Chiesi Clinical Trial Site 276701
      • Münster、德国
        • Chiesi Clinical Trial Site 276713
      • Rosenheim、德国
        • Chiesi Clinical Trial Site 276716
  • 意大利
      • Bologna、意大利
        • Chiesi Clinical Trial Site 380704
      • Catania、意大利
        • Chiesi Clinical Trial Site 380703
      • Genova、意大利
        • Chiesi Clinical Trial Site 380701
      • Palermo、意大利
        • Chiesi Clinical Trial Site 380705
      • Pavia、意大利
        • Chiesi Clinical Trial Site 380702
      • Tradate、意大利
        • Chiesi Clinical Trial Site 380706
  • 捷克语
      • Blansko、捷克语
        • Chiesi Clinical Trial Site 203711
      • Brandýs nad Labem、捷克语
        • Chiesi Clinical Trial Site 203702
      • Brno、捷克语
        • Chiesi Clinical Trial Site 203708
      • Jindřichův Hradec、捷克语
        • Chiesi Clinical Trial Site 203707
      • Kralupy nad Vltavou、捷克语
        • Chiesi Clinical Trial Site 203705
      • Miroslav、捷克语
        • Chiesi Clinical Trial Site 203709
      • Opava、捷克语
        • Chiesi Clinical Trial Site 203704
      • Prague、捷克语
        • Chiesi Clinical Trial Site 203701
      • Prague、捷克语
        • Chiesi Clinical Trial Site 203703
      • Prague、捷克语
        • Chiesi Clinical Trial Site 203710
      • Rokycany、捷克语
        • Chiesi Clinical Trial Site 203713
      • Teplice、捷克语
        • Chiesi Clinical Trial Site 203706
      • Varnsdorf、捷克语
        • Chiesi Clinical Trial Site 203712
  • 斯洛伐克
      • Bratislava、斯洛伐克
        • Chiesi Clinical Trial Site 703704
      • Bratislava、斯洛伐克
        • Chiesi Clinical Trial Site 703707
      • Ilava、斯洛伐克
        • Chiesi Clinical Trial Site 703702
      • Košice、斯洛伐克
        • Chiesi Clinical Trial Site 703705
      • Košice、斯洛伐克
        • Chiesi Clinical Trial Site 703706
      • Nové Zámky、斯洛伐克
        • Chiesi Clinical Trial Site 703701
      • Prievidza、斯洛伐克
        • Chiesi Clinical Trial Site 703709
      • Spišská Nová Ves、斯洛伐克
        • Chiesi Clinical Trial Site 703703
      • Štúrovo、斯洛伐克
        • Chiesi Clinical Trial Site 703708
  • 波兰
      • Bialystok、波兰
        • Chiesi Clinical Trial Site 616713
      • Bialystok、波兰
        • Chiesi Clinical Trial Site 616718
      • Bielsko-Biala、波兰
        • Chiesi Clinical Trial Site 616722
      • Bienkówka、波兰
        • Chiesi Clinical Trial Site 616702
      • Bydgoszcz、波兰
        • Chiesi Clinical Trial Site 616727
      • Giżycko、波兰
        • Chiesi Clinical Trial Site 616704
      • Grudziądz、波兰
        • Chiesi Clinical Trial Site 616716
      • Katowice、波兰
        • Chiesi Clinical Trial Site 616725
      • Katowice、波兰
        • Chiesi Clinical Trial Site 616729
      • Krakow、波兰
        • Chiesi Clinical Trial Site 616719
      • Krakow、波兰
        • Chiesi Clinical Trial Site 616734
      • Krakow、波兰
        • Chiesi Clinical Trial Site 616736
      • Lodz、波兰
        • Chiesi Clinical Trial Site 616707
      • Lodz、波兰
        • Chiesi Clinical Trial Site 616708
      • Lodz、波兰
        • Chiesi Clinical Trial Site 616711
      • Lodz、波兰
        • Chiesi Clinical Trial Site 616726
      • Mrozy、波兰
        • Chiesi Clinical Trial Site 616733
      • Ostróda、波兰
        • Chiesi Clinical Trial Site 616717
      • Otwock、波兰
        • Chiesi Clinical Trial Site 616731
      • Pabianice、波兰
        • Chiesi Clinical Trial Site 616703
      • Poznan、波兰
        • Chiesi Clinical Trial Site 616709
      • Poznan、波兰
        • Chiesi Clinical Trial Site 616728
      • Proszowice、波兰
        • Chiesi Clinical Trial Site 616720
      • Rzeszów、波兰
        • Chiesi Clinical Trial Site 616723
      • Rzeszów、波兰
        • Chiesi Clinical Trial Site 616735
      • Skierniewice、波兰
        • Chiesi Clinical Trial Site 616721
      • Strzelce Opolskie、波兰
        • Chiesi Clinical Trial Site 616732
      • Tarnów、波兰
        • Chiesi Clinical Trial Site 616710
      • Warsaw、波兰
        • Chiesi Clinical Trial Site 616701
      • Wilkowice、波兰
        • Chiesi Clinical Trial Site 616730
      • Wroclaw、波兰
        • Chiesi Clinical Trial Site 616705
      • Wroclaw、波兰
        • Chiesi Clinical Trial Site 616714
      • Wroclaw、波兰
        • Chiesi Clinical Trial Site 616715
      • Świdnik、波兰
        • Chiesi Clinical Trial Site 616712
  • 白俄罗斯
      • Homyel、白俄罗斯
        • Chiesi Clinical Trial Site 112703
      • Homyel、白俄罗斯
        • Chiesi Clinical Trial Site 112704
      • Minsk、白俄罗斯
        • Chiesi Clinical Trial Site 112701
      • Minsk、白俄罗斯
        • Chiesi Clinical Trial Site 112702
      • Minsk、白俄罗斯
        • Chiesi Clinical Trial Site 112705
  • 立陶宛
      • Vilnius、立陶宛
        • Chiesi Clinical Trial Site 440702
      • Vilnius、立陶宛
        • Chiesi Clinical Trial Site 440703
      • Vilnius、立陶宛
        • Chiesi Clinical Trial Site 440705
      • Šiauliai、立陶宛
        • Chiesi Clinical Trial Site 440701
  • 罗马尼亚
      • Alexandru cel Bun、罗马尼亚
        • Chiesi Clinical Trial Site 642715
      • Arad、罗马尼亚
        • Chiesi Clinical Trial Site 642713
      • Bacau、罗马尼亚
        • Chiesi Clinical Trial Site 642722
      • Bragadiru、罗马尼亚
        • Chiesi Clinical Trial Site 642717
      • Brasov、罗马尼亚
        • Chiesi Clinical Trial Site 642706
      • Bucharest、罗马尼亚
        • Chiesi Clinical Trial Site 642703
      • Bucharest、罗马尼亚
        • Chiesi Clinical Trial Site 642707
      • Bucharest、罗马尼亚
        • Chiesi Clinical Trial Site 642708
      • Bucharest、罗马尼亚
        • Chiesi Clinical Trial Site 642719
      • Bucharest、罗马尼亚
        • Chiesi Clinical Trial Site 642723
      • Cluj-Napoca、罗马尼亚
        • Chiesi Clinical Trial Site 642709
      • Cluj-Napoca、罗马尼亚
        • Chiesi Clinical Trial Site 642714
      • Cluj-Napoca、罗马尼亚
        • Chiesi Clinical Trial Site 642716
      • Cluj-Napoca、罗马尼亚
        • Chiesi Clinical Trial Site 642718
      • Cluj-Napoca、罗马尼亚
        • Chiesi Clinical Trial Site 642726
      • Craiova、罗马尼亚
        • Chiesi Clinical Trial Site 642712
      • Iași、罗马尼亚
        • Chiesi Clinical Trial Site 642704
      • Iași、罗马尼亚
        • Chiesi Clinical Trial Site 642710
      • Oradea、罗马尼亚
        • Chiesi Clinical Trial Site 642705
      • Suceava、罗马尼亚
        • Chiesi Clinical Trial Site 642711
      • Timișoara、罗马尼亚
        • Chiesi Clinical Trial Site 642721
  • 英国
      • Llanelli、英国
        • Chiesi Clinical Trial Site 826702
      • London、英国
        • Chiesi Clinical Trial Site 826703
      • Manchester、英国
        • Chiesi Clinical Trial Site 826704
      • Soham、英国
        • Chiesi Clinical Trial Site 826701
  • 葡萄牙
      • Aveiro、葡萄牙
        • Chiesi Clinical Trial Site 620704
      • Figueira da Foz Municipality、葡萄牙
        • Chiesi Clinical Trial Site 620703
      • Lisbon、葡萄牙
        • Chiesi Clinical Trial Site 620702
      • Loures、葡萄牙
        • Chiesi Clinical Trial Site 620708
      • Vila Nova de Gaia、葡萄牙
        • Chiesi Clinical Trial Site 620707
  • 西班牙
      • A Coruña、西班牙
        • Chiesi Clinical Trial Site 724702
      • Badajoz、西班牙
        • Chiesi Clinical Trial Site 724703
      • Badalona、西班牙
        • Chiesi Clinical Trial Site 724706
      • Madrid、西班牙
        • Chiesi Clinical Trial Site 724701
      • Madrid、西班牙
        • Chiesi Clinical Trial Site 724704
      • Málaga、西班牙
        • Chiesi Clinical Trial Site 724705
      • Sabadell、西班牙
        • Chiesi Clinical Trial Site 724707
  • 阿根廷
      • Buenos Aires、阿根廷
        • Chiesi Clinical Trial Site 432702
      • CABA、阿根廷
        • Chiesi Clinical Trial Site 432704
      • Mar del Plata、阿根廷
        • Chiesi Clinical Trial Site 432705
      • Quilmes、阿根廷
        • Chiesi Clinical Trial Site 432701
      • San Miguel de Tucumán、阿根廷
        • Chiesi Clinical Trial Site 432703
      • San Miguel de Tucumán、阿根廷
        • Chiesi Clinical Trial Site 432706

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

不

描述

纳入标准：

  • 哮喘病史≥1年且40岁前确诊
  • 仅使用高剂量吸入皮质类固醇 (ICS) 联合长效 β2 激动剂 (LABA) 进行双重治疗的未控制哮喘，ACQ-7（哮喘控制问卷）≥1.5
  • 支气管扩张剂前 FEV1 < 预计正常值的 80%
  • 阳性可逆性试验
  • 前一年至少有 1 次哮喘发作记录

排除标准：

  • 孕妇或哺乳期妇女
  • 慢性阻塞性肺疾病 (COPD) 的诊断
  • 筛选前 4 周内有任何哮喘发作或呼吸道感染的患者
  • 当前吸烟者或戒烟者（>= 10 包年）
  • 在筛选前 4 周内 ICS + LABA 组合的剂量、时间表或配方有任何变化

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：瑞士法郎 5993 200/6/12.5 微克

治疗一：

瑞士法郎 5993 200/6/12.5 µg：两次吸入 bid 每日总剂量：800/24/50 µg BDP/FF/GB
药品：瑞士法郎 5993 200/6/12.5 微克
有源比较器：瑞士法郎 1535 200/6 微克

治疗B：

CHF 1535 200/6 µg：2 次吸入 bid 每日总剂量：800/24 µg BDP/FF
药品：瑞士法郎 1535 200/6 微克
有源比较器：CHF 1535 200/6 µg + 噻托溴铵 Respimat 2.5 µg

治疗 C（开放标签组）：

CHF 1535 200/6 µg：2 次吸入出价

+ 噻托溴铵 Respimat 2.5 µg：2 次吸入 od 每日总剂量：800/24 µg BDP/FF + 5 µg Tio
药品：CHF 1535 200/6 µg + 噻托溴铵 Respimat 2.5 µg

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
1_Change From Baseline in Pre-Dose Forced Expiratory Volume in the First Second (FEV1) at Week 26
大体时间：Week 0 (pre-treatment, baseline) to Week 26.

Change from baseline in pre-dose FEV1, analysed at Week 26 of treatment.

FEV1=Forced expiratory volume in the first second
Week 0 (pre-treatment, baseline) to Week 26.
2_Moderate and Severe Asthma Exacerbation Rate Over the 52-Week Treatment Period
大体时间：Week 0 (pre-treatment, baseline) to Week 52.

Asthma exacerbation intensity: Moderate AND Severe Asthma Exacerbation

Severe: asthma worsening requiring initiation of treatment with systemic corticosteroids for at least 3 days (courses of corticosteroids separated by ≥1 week treated as separate severe exacerbations).

Moderate: ≥1 of the following criteria fulfilled and leading to a change in treatment (sustained increase of ≥1 puff of short acting beta 2-agonist [SABA] for 2 consecutive days) as shown below:

  • Nocturnal awakening(s) due to asthma requiring SABA for 2 consecutive nights/increase of ≥ 0.75 from baseline in daily symptom score on 2 consecutive days; increase from baseline in occasions of SABA use on 2 consecutive days (minimum increase 4 puffs/day);
  • ≥20% decrease in peak expiratory flow from baseline on at least 2 consecutive mornings/evenings or ≥ 20% decrease in FEV1 from baseline;
  • Visit to the ER/trial site for asthma treatment not requiring systemic corticosteroid;
Week 0 (pre-treatment, baseline) to Week 52.

次要结果测量

结果测量
措施说明
大体时间
3_Change From Baseline in Peak(0-3h) FEV1 at Week 26
大体时间：Week 0 (pre-treatment, baseline) and Week 26.

Peak peak of forced expiratory volume in the first second (FEV1) within 3 hours post-dose.

FEV1=Forced expiratory volume in the first second
Week 0 (pre-treatment, baseline) and Week 26.
4_Change From Baseline in Morning Peak Expiratory Flow (PEF) Over the 26-Week Treatment
大体时间：Week 0 (pre-treatment, baseline) to Week 26.

Change from baseline in the average morning PEF (Litre/min), measured by patients at home over the 26-week treatment period (i.e., up to Week 26).

PEF=Peak Expiratory Flow; is the maximal airflow forcefully expelled from the lungs in one quick exhalation.
Week 0 (pre-treatment, baseline) to Week 26.
5_Severe Asthma Exacerbation Rate Over the 52-Week Treatment Period - Pooled Analysis
大体时间：The entire treatment period; up to Week 52.

Severe asthma exacerbation rate over the 52-Week treatment period in a pre-specified pooled analysis of 2 pivotal studies CCD-05993AB1-03 (TRIMARAN) and CCD-05993AB2-02 (TRIGGER).

The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling.
The entire treatment period; up to Week 52.
6_Change From Baseline in Peak FEV1 (0-3h) at All Clinical Visits
大体时间：Week 0 (pre-treatment, baseline) to Week 52.

The peak (0-3h) FEV1 at baseline and at all subsequent visits, and the respective changes from baseline are presented by treatment group for all clinical visits.

Baseline for pre-dose FEV1 was calculated as average of the FEV1 measurements (L) from the visit 2 (V2) Pre45min & V2 Pre15min. If one of the two pre-dose values was missing, the baseline was equal to the available pre-dose value.

FEV1=Forced expiratory volume in the first second
Week 0 (pre-treatment, baseline) to Week 52.
7_Change From Baseline in Pre-Dose FEV1 at All Clinical Visits
大体时间：Week 0 (pre-treatment, baseline) to Week 52.

Results show the change from baseline in pre-dose FEV1 at all clinical visits.

FEV1=Forced expiratory volume in the first second
Week 0 (pre-treatment, baseline) to Week 52.
8_FEV1 Response (FEV1 ≥ 100 mL) at Week 26 and Week 52
大体时间：Week 0 (pre-treatment, baseline) to Week 26 and Week 52.

Results show the percentage of patients classified as FEV1 responders at Week 26 and at Week 52.

The FEV1 response was defined as: Change from baseline in pre-dose morning FEV1 ≥ 100 mL.

FEV1=Forced expiratory volume in the first second
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
9_Change From Baseline in FEV1 Area Under the Curve (AUC) (0-3h) Normalised by Time at All Clinical Visits
大体时间：Week 0 (pre-treatment, baseline) to Week 52.

Baseline definition: mean of two pre-dose FEV1 measurements at visit 2 (V2).

Results show the change from baseline in FEV1 area under the curve [AUC] (0-3h) at all subsequent visits (i.e. change from baseline of the AUC of the serial post-dose spirometry assessments till 3h post-dose).

FEV1=Forced expiratory volume in the first second
Week 0 (pre-treatment, baseline) to Week 52.
10_Change From Baseline in the Asthma Control Questionnaire-7 (ACQ-7) Score at All Clinical Visits
大体时间：Week 0 (pre-treatment, baseline) to Week 52.

ACQ-7 Questionnaire.

ACQ-7 allows assessment of asthma control in individual patients.

The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue medication use and 1 on lung function (FEV1 % predicted). All seven items are scored on a 7-point Likert scale, with 0 indicating total control (no impairment) and 6 indicating poor control (maximum impairment). The questions are equally weighted and the total score is the mean of the seven items. The first 6 questions of the ACQ-7 were completed by the participant while the last question was completed by the study investigator using data from the Master Scope spirometer.

Baseline for ACQ-7 was the total score recorded at Visit 2 (Week 0) of the study. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. A negative change from baseline indicates improvement in lung function.
Week 0 (pre-treatment, baseline) to Week 52.
11_Asthma Control Questionnaire©-7 Response at Week 26 and Week 52
大体时间：Week 0 (pre-treatment, baseline) to Week 26 and Week 52.

Asthma Control Questionnaire (ACQ) and Asthma Control Questionnaire-7 (QAC-7) are defined in the description of Outcome measure 10 above.

An ACQ-7 response was defined as change from baseline (Week 0, pre-dose) in ACQ-7 score ≤ -0.5; non-response was defined as change from baseline in ACQ-7 score >-0.5 or missing data.

Results represent responders (i.e. change from baseline in ACQ-7 Score ≤ -0.5) at Week 26 and at Week 52.
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
12_Change From Baseline in Average Morning PEF (L/Min) Over 52 Weeks of Treatment
大体时间：Week 0 (pre-treatment, baseline) to Week 52.

Change from baseline in average MORNING PEF (L/min) over 52 weeks of treatment.

PEF=Peak Expiratory Flow; is the maximal airflow forcefully expelled from the lungs in one quick exhalation.
Week 0 (pre-treatment, baseline) to Week 52.
12a_Change From Baseline in Average Evening PEF (L/Min) Over 26 and 52 Weeks of Treatment
大体时间：Week 0 (pre-treatment, baseline) to Week 26 and Week 52.

Change from baseline in average EVENING PEF (L/min) over 26 and 52 weeks of treatment.

PEF=Peak Expiratory Flow; is the maximal airflow forcefully expelled from the lungs in one quick exhalation.
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
13_Number of Patients at Risk of Moderate or Severe Asthma Exacerbation Over 52 Weeks
大体时间：Week 0 (pre-treatment, baseline) to Week 52.

Number of patients at risk of a moderate or severe asthma exacerbation.

Results show the number of patients who had moderate or severe asthma exacerbation over the 52 weeks treatment period.
Week 0 (pre-treatment, baseline) to Week 52.
14_Number of Patients at Risk of Severe Asthma Exacerbation in the Pooled Analysis of the Two Pivotal Studies CCD-05993AB1-03 and CCD-05993AB2-02
大体时间：Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.

Number of patients at risk of a SEVERE asthma exacerbation in the pooled analysis of the two pivotal studies CCD-05993AB1-03 (TRIMARAN) and CCD-05993AB2-02 (TRIGGER), over the 52 weeks treatment period.

The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling.
Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
15_Moderate Asthma Exacerbation Rate Over the 52-Week Treatment Period in the Pooled Analysis of the 2 Pivotal Studies CCD-05993AB1-03 and CCD-055993AB2-02.
大体时间：Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.

MODERATE asthma exacerbation rate over the 52-Week treatment period in the pooled analysis of the 2 pivotal studies CCD-05993AB1-03 (TRIMARAN) and CCD-055993AB2-02 (TRIGGER).

The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling.
Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
16_Number of Patients at Risk of MODERATE Asthma Exacerbation in the Pooled Analysis of the Two Pivotal Studies CCD-05993AB1-03 and CCD-05993AB2-02
大体时间：Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.

Number of Patients at Risk of MODERATE Asthma Exacerbation in the Pooled Analysis of the Two Pivotal Studies CCD-05993AB1-03 and CCD-05993AB2-02.

The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling.
Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
17_Moderate and Severe Asthma Exacerbation Rate Over the 52-Week Treatment Period in the Pooled Analysis of the 2 Pivotal Studies CCD-05993AB1-03 and CCD-055993AB2-02
大体时间：Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.

Moderate AND severe asthma exacerbation rate over the 52-Week treatment period in the pooled analysis of the 2 pivotal studies CCD-05993AB1-03 (TRIMARAN) and CCD-05993AB2-02 (TRIGGER).

The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling.
Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
18_Number of Patients at Risk of Moderate OR Severe Asthma Exacerbation in the Pooled Analysis of the Two Pivotal Studies CCD-05993AB1-03 and CCD-05993AB2-02
大体时间：Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.

Time to first MODERATE OR SEVERE asthma exacerbation in the Pooled Analysis of the 2 Pivotal Studies CCD-05993AB1-03 (TRIMARAN) and CCD-05993AB2-02 (TRIGGER).

The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling.
Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
19_Moderate Asthma Exacerbation Rate Over the 52-Week Treatment Period
大体时间：Week 0 (pre-treatment, baseline) to Week 52.

MODERATE asthma exacerbation rate over the 52-Week treatment period.

Asthma exacerbation intensity: Moderate: ≥1 of the following criteria fulfilled and leading to a change in treatment (sustained increase of ≥1 puff of short acting beta 2-agonist [SABA] for 2 consecutive days) as shown below:

  • Nocturnal awakening(s) due to asthma requiring SABA for 2 consecutive nights/increase of ≥ 0.75 from baseline in daily symptom score on 2 consecutive days; increase from baseline in occasions of SABA use on 2 consecutive days (minimum increase 4 puffs/day);
  • ≥20% decrease in peak expiratory flow from baseline on at least 2 consecutive mornings/evenings or ≥ 20% decrease in FEV1 from baseline;
  • Visit to the ER/trial site for asthma treatment not requiring systemic corticosteroid;
Week 0 (pre-treatment, baseline) to Week 52.
20_Number of Patients at Risk of a MODERATE Asthma Exacerbation
大体时间：Week 0 (pre-treatment, baseline) to Week 52.
Data were analysed for the number of patients at risk of a MODERATE asthma exacerbation.
Week 0 (pre-treatment, baseline) to Week 52.
21_Change From Baseline in the Average Use of Rescue Medication Over the 26- and 52-Week Treatment Periods
大体时间：Week 0 (pre-treatment, baseline) to Week 26 and Week 52.

Change from baseline in the average use of rescue medication over the 26- and 52-Week treatment periods.

Data was collected through an electronic daily diary from screening to the end of the study.
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
21a_Change From Baseline in the Average Use of Rescue Medication in Each Inter-Visit Period
大体时间：Week 0 (pre-treatment, baseline) to Week 52.

Results show the change from baseline in the average use (puffs/day) of rescue medication in each inter-visit period.

Data was collected through an electronic daily diary from screening to the end of the study.
Week 0 (pre-treatment, baseline) to Week 52.
22_Change From Baseline in the Percentage of Rescue Medication-Free Days Over the 26- and 52-Week Treatment Periods
大体时间：Week 0 (pre-treatment, baseline) to Week 26 and Week 52.

Change from baseline in the percentage of rescue medication-free days over the 26- and 52-Week treatment periods.

Data was collected using an electronic daily diary, from screening to the end of the study.
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
22a_Change From Baseline in the Percentage of Rescue Medication-Free Days in Each Inter-Visit Period Over the Treatment
大体时间：Week 0 (pre-treatment, baseline) to Week 52.

Results show the change from baseline in the percentage of rescue medication-free days in each inter-visit period over the entire treatment.

Data was collected through an electronic daily diary from screening to the end of the study.
Week 0 (pre-treatment, baseline) to Week 52.
23_Change From Baseline in the Average Total Daily Asthma Symptom Scores Over the 26- and 52-Week Treatment Periods
大体时间：Week 0 (pre-treatment, baseline) to Week 26 and Week 52.

Results show the change from baseline in the average total daily asthma symptom scores over the 26- and 52-Weeks of treatment. A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day.

Symptoms considered: cough, wheeze, chest tightness, breathlessness.

Morning (night-time asthma symptom score):

  • 0 No symptoms;
  • 1 Mild = Symptoms not causing awakening;
  • 2 Moderate = Discomfort enough to cause awakenings;
  • 3 Severe = Causing awakenings for most of the night/did not sleep at all.

Evening (daytime asthma symptom score):

  • 0 No symptoms;
  • 1 Mild = Aware of symptoms, which could be easily tolerated;
  • 2 Moderate = Discomfort enough to cause interference with daily activity;
  • 3 Severe = Incapacitating
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
23a_Change From Baseline in the Average Daily Asthma Symptom Scores in Each Inter-Visit Period
大体时间：Week 0 (pre-treatment, baseline) to Week 52.

Results show the change from baseline in the average total daily asthma symptom scores over the 26- and 52-Weeks of treatment. A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day.

Symptoms considered: cough, wheeze, chest tightness, breathlessness.

Morning (night-time asthma symptom score):

  • 0 No symptoms;
  • 1 Mild = Symptoms not causing awakening;
  • 2 Moderate = Discomfort enough to cause awakenings;
  • 3 Severe = Causing awakenings for most of the night/did not sleep at all.

Evening (daytime asthma symptom score):

  • 0 No symptoms;
  • 1 Mild = Aware of symptoms, which could be easily tolerated;
  • 2 Moderate = Discomfort enough to cause interference with daily activity;
  • 3 Severe = Incapacitating
Week 0 (pre-treatment, baseline) to Week 52.
24_Change From Baseline in the Percentage of Asthma Symptom-Free Days Over the 26- and 52-Week Treatment Periods
大体时间：Week 0 (pre-treatment, baseline) to Week 26 and Week 52.

Change from baseline in the percentage of asthma symptom-free days over the 26- and 52-Week treatment periods.

Data was collected through an electronic daily diary from screening to the end of the study.

Results show the change from baseline in the average daily asthma symptom scores over the 26- and 52-Week treatment periods. A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day.

Symptoms considered by the questionnaire: cough, wheeze, chest tightness, breathlessness.

An asthma symptom-free day is a day with total daily asthma symptom score = 0. For a description of the score see outcome measure number 23.
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
24a_Change From Baseline in the Percentage of Asthma Symptom-Free Days in Each Inter-Visit Periods
大体时间：Week 0 (pre-treatment, baseline) to Week 52.

Results show the change from baseline in the percentage of asthma symptom-free days in each inter-visit periods over the entire treatment.

Data was collected through an electronic daily diary from screening to end of the study.

A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day.

Symptoms considered by the questionnaire: cough, wheeze, chest tightness, breathlessness.

An asthma symptom-free day is a day with total daily asthma symptom score = 0. For a description of the score see outcome measure number 23.
Week 0 (pre-treatment, baseline) to Week 52.
25_Change From Baseline in the Percentage of Asthma Control Days Over the 26- and 52-Week Treatment Periods
大体时间：Week 0 (pre-treatment, baseline) to Week 26 and Week 52.

Results show the change from baseline in the percentage of asthma control days over the 26- and 52-Week treatment periods.

Data was collected through an electronic daily diary from screening to the end of the study.

Scoring of asthma symptoms (overall symptoms, cough, wheeze, chest tightness and breathlessness):

Morning (night-time asthma symptoms): 0 (no symptoms), 1 (mild - symptoms not causing awakening), 2 (moderate - discomfort enough to cause awakenings) and 3 (severe - causing awakenings for most of the night/did not sleep at all).

Evening (daytime asthma symptoms): 0 (no symptoms), 1 (mild: aware of symptoms that could be easily tolerated), 2 (moderate: discomfort enough to cause interference with daily activity), 3 (severe: incapacitating with inability to work/take part in usual activity).
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
25a_Change From Baseline in the Percentage of Asthma Control Days in Each Inter-Visit Period
大体时间：Week 0 (pre-treatment, baseline) to Week 52.

A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day.

Data was collected through an electronic daily diary from screening to the end of the study.

Scoring of asthma symptoms (overall symptoms, cough, wheeze, chest tightness and breathlessness):

Morning (night-time asthma symptoms): 0 (no symptoms), 1 (mild - symptoms not causing awakening), 2 (moderate - discomfort enough to cause awakenings) and 3 (severe - causing awakenings for most of the night/did not sleep at all).

Evening (daytime asthma symptoms): 0 (no symptoms), 1 (mild: aware of symptoms that could be easily tolerated), 2 (moderate: discomfort enough to cause interference with daily activity), 3 (severe: incapacitating with inability to work/ take part in usual activity).
Week 0 (pre-treatment, baseline) to Week 52.

其他结果措施

结果测量
措施说明
大体时间
不良事件和药物不良反应
大体时间：直到第 52 周
直到第 52 周
收集卫生经济学成果
大体时间：第 0 周到第 52 周
医疗资源的总使用和缺勤
第 0 周到第 52 周

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Chiesi Farmaceutici S.p.A.

调查人员

  • 首席研究员：Georgio Walter Canonica, MD、University of Medicine, Genoa, Italy

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年4月6日

初级完成 (实际的)

2018年5月28日

研究完成 (实际的)

2018年5月28日

研究注册日期

首次提交

2016年2月3日

首先提交符合 QC 标准的

2016年2月3日

首次发布 (估计的)

2016年2月8日

研究记录更新

最后更新发布 (实际的)

2026年6月26日

上次提交的符合 QC 标准的更新

2026年6月2日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CCD-05993AB2-02
  • 2015-000717-40 (EudraCT编号)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Chiesi 承诺与合格的科学和医学研究人员共享，进行合法研究、患者水平数据、研究水平数据、临床方案和完整的 CSR，提供对临床试验信息的访问，始终遵循保护商业机密信息和患者的原则隐私。 任何共享的患者级数据都是匿名的，以保护个人身份信息。

Chiesi 集团网站上提供了 Chiesi 访问标准和完整的临床数据共享流程。

IPD 共享时间框架

See information above in Plan Description regarding Chiesi's commitment to share information with qualified scientific and medical researchers, conducting legitimate research

Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.

IPD 共享访问标准

Chiesi 集团网站上提供了 Chiesi 访问标准和完整的临床数据共享流程。

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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