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比较固定剂量三联组合 CHF 5993 与固定剂量双联组合 CHF 1535 在 COPD 受试者中的疗效、安全性和耐受性的研究 (TRITON)

2026年9月17日 更新者：Chiesi Farmaceutici S.p.A.

一项 III 期、为期 52 周、多国、多中心、随机、双盲、双臂平行组研究，比较固定剂量二丙酸倍氯米松加福莫特罗富马酸盐加格隆溴铵 (CHF 5993) 三重组合的疗效、安全性和耐受性双丙酸倍氯米松加富马酸福莫特罗 (CHF 1535) 的固定剂量双重组合，均通过 pMDI 对慢性阻塞性肺疾病 (COPD) 患者给药

The purpose of this study is to compare CHF 5993 with CHF 1535 in improving lung function, reducing moderate and severe COPD exacerbations, and other clinical efficacy and safety outcomes in the target subject population.

研究概览

地位

完全的

条件

干预/治疗

详细说明

This is a phase III, multinational, multicenter, randomized, double-blind active controlled 2-arm parallel group study to compare efficacy, safety, and tolerability of CHF 5993 pMDI with CHF 1535 pMDI with respect to lung function, incidence of moderate and severe COPD exacerbations, and other clinical efficacy and safety outcomes.

After screening, eligible subjects will enter 2-week run-in period using their regular COPD maintenance therapies after which they will be randomized to one of 2 study treatment groups. Following randomization, subjects will be assessed after 4 weeks then at 6-week intervals thereafter for a period of 52 weeks. A follow-up safety phone call will be performed a week after the last clinic visit. A subset of subjects consenting to participate in the pharmacokinetic substudy will undergo additional assessments (totaling 3 visits) during the scheduled study visits.

During the study, daily symptoms, rescue medication use and compliance with the study drug will be recorded via a subject electronic diary. Subject concomitant medications, adverse events, and healthcare resource utilization will be assessed and recorded throughout the study. At intermittent study visits, subjects will undergo vital signs examinations including weight, spirometry measurements, and 12-lead ECG. Symptoms and COPD health status will be assessed through disease specific questionnaires. Routine hematology, blood chemistry, and serum pregnancy testing will be performed before enrollment and at end of study.

研究类型

介入性

注册 (实际的)

3406

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

  • 保加利亚
      • Gabrovo、保加利亚
        • Chiesi Clinical Trial Site 100125
      • Haskovo、保加利亚
        • Chiesi Clinical Trial Site 100109
      • Kozloduy、保加利亚、3320
        • Chiesi Clinical Trial Site 100129
      • Lovech、保加利亚
        • Chiesi Clinical Trial Site 100111
      • Montana、保加利亚
        • Chiesi Clinical Trial Site 100115
      • Pleven、保加利亚、5808
        • Chiesi Clinical Trial Site 100132
      • Pleven、保加利亚
        • Chiesi Clinical Trial Site 100101
      • Plovdiv、保加利亚、4003
        • Chiesi Clinical Trial Site 100131
      • Plovdiv、保加利亚
        • Chiesi Clinical Trial Site 100102
      • Plovdiv、保加利亚
        • Chiesi Clinical Trial Site 100126
      • Razgrad、保加利亚、7200
        • Chiesi Clinical Trial Site 100128
      • Rousse、保加利亚
        • Chiesi Clinical Trial Site 100104
      • Rousse、保加利亚
        • Chiesi Clinical Trial Site 100113
      • Sofia、保加利亚
        • Chiesi Clinical Trial Site 100100
      • Sofia、保加利亚
        • Chiesi Clinical Trial Site 100110
      • Sofia、保加利亚
        • Chiesi Clinical Trial Site 100112
      • Sofia、保加利亚
        • Chiesi Clinical Trial Site 100116
      • Sofia、保加利亚
        • Chiesi Clinical Trial Site 100117
      • Sofia、保加利亚
        • Chiesi Clinical Trial Site 100118
      • Sofia、保加利亚
        • Chiesi Clinical Trial Site 100119
      • Sofia、保加利亚
        • Chiesi Clinical Trial Site 100121
      • Sofia、保加利亚
        • Chiesi Clinical Trial Site 100123
      • Sofia、保加利亚
        • Chiesi Clinical Trial Site 100124
      • Sofia、保加利亚
        • Chiesi Clinical Trial Site 100127
      • Stara Zagora、保加利亚
        • Chiesi Clinical Trial Site 100103
      • Stara Zagora、保加利亚
        • Chiesi Clinical Trial Site 100107
      • Varna、保加利亚、9020
        • Chiesi Clinical Trial Site 100130
      • Veliko Tarnovo、保加利亚
        • Chiesi Clinical Trial Site 100122
      • Vidin、保加利亚
        • Chiesi Clinical Trial Site 100106
      • Vidin、保加利亚
        • Chiesi Clinical Trial Site 100114
  • 加拿大
    • Alberta
      • Edmonton、Alberta、加拿大、T5A 4L8
        • Chiesi Clinical Trial Site 124103
      • Sherwood Park、Alberta、加拿大、T8H 0N2
        • Chiesi Clinical Trial Site 124105
    • Ontario
      • Burlington、Ontario、加拿大、L7N 3V2
        • Chiesi Clinical Trial Site 124102
      • Greater Sudbury、Ontario、加拿大、P3C 1X3
        • Chiesi Clinical Trial Site 124104
      • Windsor、Ontario、加拿大、N8X 1T3
        • Chiesi Clinical Trial Site 124100
    • Quebec
      • Trois-Rivières、Quebec、加拿大、G8T 7A1
        • Chiesi Clinical Trial Site 124106
  • 匈牙利
      • Debrecen、匈牙利
        • Chiesi Clinical Trial Site 348118
      • Hajdúnánás、匈牙利
        • Chiesi Clinical Trial Site 348112
      • Hatvan、匈牙利
        • Chiesi Clinical Trial Site 348116
      • Monor、匈牙利
        • Chiesi Clinical Trial Site 348103
      • Sellye、匈牙利、7960
        • Chiesi Clinical Trial Site 348125
    • BA
      • Komló、BA、匈牙利、7300
        • Chiesi Clinical Trial Site 348121
      • Pécs、BA、匈牙利、7626
        • Chiesi Clinical Trial Site 348122
    • GS
      • Csorna、GS、匈牙利、9300
        • Chiesi Clinical Trial Site 348124
    • JN
      • Szolnok、JN、匈牙利、5000
        • Chiesi Clinical Trial Site 348126
    • Nógrád megye
      • Balassagyarmat、Nógrád megye、匈牙利
        • Chiesi Clinical Trial Site 348107
    • Pest County
      • Gödöllő、Pest County、匈牙利
        • Chiesi Clinical Trial Site 348120
    • Szabolcs-Szatmár-Bereg
      • Nyíregyháza、Szabolcs-Szatmár-Bereg、匈牙利
        • Chiesi Clinical Trial Site 348104
      • Nyíregyháza、Szabolcs-Szatmár-Bereg、匈牙利
        • Chiesi Clinical Trial Site 348109
    • Vas County
      • Szombathely、Vas County、匈牙利
        • Chiesi Clinical Trial Site 348105
  • 墨西哥
      • Chihuahua City、墨西哥、31217
        • Chiesi Clinical Trial Site 484116
      • Chihuahua City、墨西哥
        • Chiesi Clinical Trial Site 484105
      • Chihuahua City、墨西哥
        • Chiesi Clinical Trial Site 484109
      • Tlalpan、墨西哥
        • Chiesi Clinical Trial Site 484108
    • Estado de Baja California
      • Tijuana、Estado de Baja California、墨西哥
        • Chiesi Clinical Trial Site 484110
    • Jalisco
      • Guadalajara、Jalisco、墨西哥、44610
        • Chiesi Clinical Trial Site 484113
      • Guadalajara、Jalisco、墨西哥
        • Chiesi Clinical Trial Site 484100
      • Guadalajara、Jalisco、墨西哥
        • Chiesi Clinical Trial Site 484102
      • Guadalajara、Jalisco、墨西哥
        • Chiesi Clinical Trial Site 484104
      • Guadalajara、Jalisco、墨西哥
        • Chiesi Clinical Trial Site 484106
      • Guadalajara、Jalisco、墨西哥
        • Chiesi Clinical Trial Site 484112
      • Guadalupe、Jalisco、墨西哥、44200
        • Chiesi Clinical Trial Site 484115
    • Mexico City
      • Cuauhtémoc、Mexico City、墨西哥
        • Chiesi Clinical Trial Site 484103
    • Michoacán
      • Morelia、Michoacán、墨西哥
        • Chiesi Clinical Trial Site 484107
    • Nuevo León
      • Monterrey、Nuevo León、墨西哥
        • Chiesi Clinical Trial Site 484101
      • Monterrey、Nuevo León、墨西哥
        • Chiesi Clinical Trial Site 484111
  • 捷克语
      • Brandýs nad Labem、捷克语
        • Chiesi Clinical Trial Site 203101
      • Jindřichův Hradec、捷克语
        • Chiesi Clinical Trial Site 203107
      • Miroslav、捷克语
        • Chiesi Clinical Trial Site 203109
      • Prague、捷克语、11000
        • Chiesi Clinical Trial Site 203116
      • Prague、捷克语、140 00
        • Chiesi Clinical Trial Site 203115
      • Prague、捷克语
        • Chiesi Clinical Trial Site 203114
      • Rokycany、捷克语
        • Chiesi Clinical Trial Site 203112
      • Strakonice、捷克语
        • Chiesi Clinical Trial Site 203108
      • Teplice、捷克语
        • Chiesi Clinical Trial Site 203104
      • Tábor、捷克语
        • Chiesi Clinical Trial Site 203105
      • Varnsdorf、捷克语
        • Chiesi Clinical Trial Site 203110
  • 波兰
      • Bialystok、波兰、15-003
        • Chiesi Clinical Trial Site 616125
      • Bialystok、波兰
        • Chiesi Clinical Trial Site 616119
      • Giżycko、波兰
        • Chiesi Clinical Trial Site 616100
      • Grudziądz、波兰
        • Chiesi Clinical Trial Site 616113
      • Katowice、波兰
        • Chiesi Clinical Trial Site 616116
      • Krakow、波兰、30-149
        • Chiesi Clinical Trial Site 616122
      • Krakow、波兰
        • Chiesi Clinical Trial Site 616106
      • Krakow、波兰
        • Chiesi Clinical Trial Site 616109
      • Krakow、波兰
        • Chiesi Clinical Trial Site 616118
      • Lodz、波兰
        • Chiesi Clinical Trial Site 616103
      • Olsztyn、波兰
        • Chiesi Clinical Trial Site 616128
      • Ostrowiec、波兰
        • Chiesi Clinical Trial Site 616117
      • Ostróda、波兰
        • Chiesi Clinical Trial Site 616105
      • Poznan、波兰、60-214
        • Chiesi Clinical Trial Site 616123
      • Poznan、波兰
        • Chiesi Clinical Trial Site 616107
      • Poznan、波兰
        • Chiesi Clinical Trial Site 616110
      • Rzeszów、波兰
        • Chiesi Clinical Trial Site 616108
      • Skierniewice、波兰
        • Chiesi Clinical Trial Site 616114
      • Skorzewo、波兰、60-185
        • Chiesi Clinical Trial Site 616120
      • Sosnowiec、波兰
        • Chiesi Clinical Trial Site 616102
      • Tarnów、波兰
        • Chiesi Clinical Trial Site 616111
      • Torun、波兰
        • Chiesi Clinical Trial Site 616115
      • Warsaw、波兰、00-215
        • Chiesi Clinical Trial Site 616127
      • Wroclaw、波兰、54-239
        • Chiesi Clinical Trial Site 616126
      • Wroclaw、波兰
        • Chiesi Clinical Trial Site 616104
      • Wroclaw、波兰
        • Chiesi Clinical Trial Site 616112
      • Zawadzkie、波兰
        • Chiesi Clinical Trial Site 616101
  • 波多黎各
      • Guaynabo、波多黎各、00968
        • Chiesi Clinical Trial Site 840393
  • 罗马尼亚
      • Bacau、罗马尼亚、600252
        • Chiesi Clinical Trial Site 642109
      • Bragadiru、罗马尼亚、077025
        • Chiesi Clinical Trial Site 642106
      • Brasov、罗马尼亚、500283
        • Chiesi Clinical Trial Site 642117
      • Bucharest、罗马尼亚、020125
        • Chiesi Clinical Trial Site 642103
      • Bucharest、罗马尼亚、11025
        • Chiesi Clinical Trial Site 642113
      • Bucharest、罗马尼亚、012071
        • Chiesi Clinical Trial Site 642108
      • Caracal、罗马尼亚、235200
        • Chiesi Clinical Trial Site 642115
      • Cluj-Napoca、罗马尼亚、400275
        • Chiesi Clinical Trial Site 642111
      • Constanța、罗马尼亚、900433
        • Chiesi Clinical Trial Site 642105
      • Craiova、罗马尼亚、200515
        • Chiesi Clinical Trial Site 642110
      • Craiova、罗马尼亚、200515
        • Chiesi Clinical Trial Site 642118
      • Iași、罗马尼亚、700141
        • Chiesi Clinical Trial Site 642101
      • Reșca、罗马尼亚、237143
        • Chiesi Clinical Trial Site 642114
      • Satu Mare、罗马尼亚、44055
        • Chiesi Clinical Trial Site 642112
      • Timișoara、罗马尼亚、300134
        • Chiesi Clinical Trial Site 642116
    • Bihor County
      • Oradea、Bihor County、罗马尼亚、410169
        • Chiesi Clinical Trial Site 642102
    • Cluj
      • Cluj-Napoca、Cluj、罗马尼亚、400371
        • Chiesi Clinical Trial Site 642104
    • Hunedoara County
      • Deva、Hunedoara County、罗马尼亚、330162
        • Chiesi Clinical Trial Site 642120
    • Ilfov
      • Bragadiru、Ilfov、罗马尼亚、077025
        • Chiesi Clinical Trial Site 642107
    • Timiș County
      • Timișoara、Timiș County、罗马尼亚、300336
        • Chiesi Clinical Trial Site 642119
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35215-7502
        • Chiesi Clinical Trial Site 840350
      • Dothan、Alabama、美国、36303
        • Chiesi Clinical Trial Site 840186
      • Foley、Alabama、美国、36535
        • Chiesi Clinical Trial Site 840258
      • Jasper、Alabama、美国、35501
        • Chiesi Clinical Trial Site 840279
      • Mobile、Alabama、美国、36608
        • Chiesi Clinical Trial Site 840433
      • Montgomery、Alabama、美国、36106
        • Chiesi Clinical Trial Site 840206
      • Muscle Shoals、Alabama、美国、35661
        • Chiesi Clinical Trial Site 840249
    • Arizona
      • Chandler、Arizona、美国、85224
        • Chiesi Clinical Trial Site 840406
      • Peoria、Arizona、美国、85381
        • Chiesi Clinical Trial Site 840402
      • Tucson、Arizona、美国、85741
        • Chiesi Clinical Trial Site 840349
    • California
      • Covina、California、美国、91723
        • Chiesi Clinical Trial Site 840404
      • Escondido、California、美国、92025
        • Chiesi Clinical Trial Site 840209
      • La Palma、California、美国、90623
        • Chiesi Clinical Trial Site 840427
      • Lomita、California、美国、90717
        • Chiesi Clinical Trial Site 840358
      • Newport Beach、California、美国、92663
        • Chiesi Clinical Trial Site 840173
      • Northridge、California、美国、91324
        • Chiesi Clinical Trial Site 840208
      • Northridge、California、美国、91324
        • Chiesi Clinical Trial Site 840277
      • Redding、California、美国、96001
        • Chiesi Clinical Trial Site 840364
      • Sacramento、California、美国、95821
        • Chiesi Clinical Trial Site 840226
      • Sacramento、California、美国、95823
        • Chiesi Clinical Trial Site 840405
      • San Diego、California、美国、92120
        • Chiesi Clinical Trial Site 840107
      • Santa Ana、California、美国、92705
        • Chiesi Clinical Trial Site 840373
      • Upland、California、美国、91786
        • Chiesi Clinical Trial Site 840164
      • West Covina、California、美国、91790
        • Chiesi Clinical Trial Site 840174
      • Westminster、California、美国、92683
        • Chiesi Clinical Trial Site 840144
    • Colorado
      • Aurora、Colorado、美国、80014
        • Chiesi Clinical Trial Site 840441
      • Boulder、Colorado、美国、80302
        • Chiesi Clinical Trial Site 840229
    • Connecticut
      • Norwalk、Connecticut、美国、06586
        • Chiesi Clinical Trial Site 840399
    • Florida
      • Altamonte Springs、Florida、美国、32701
        • Chiesi Clinical Trial Site 840116
      • Aventura、Florida、美国、33180
        • Chiesi Clinical Trial Site 840268
      • Brandon、Florida、美国、33511
        • Chiesi Clinical Trial Site 840192
      • Brooksville、Florida、美国、34613
        • Chiesi Clinical Trial Site 840310
      • Chiefland、Florida、美国、32626
        • Chiesi Clinical Trial Site 840240
      • Clearwater、Florida、美国、33756
        • Chiesi Clinical Trial Site 840153
      • Coral Gables、Florida、美国、33134
        • Chiesi Clinical Trial Site 840272
      • Coral Gables、Florida、美国、33134
        • Chiesi Clinical Trial Site 840304
      • Cutler Bay、Florida、美国、33157
        • Chiesi Clinical Trial Site 840193
      • Cutler Bay、Florida、美国、33189
        • Chiesi Clinical Trial Site 840311
      • Cutler Bay、Florida、美国、33189
        • Chiesi Clinical Trial Site 840335
      • Daytona Beach、Florida、美国、32117
        • Chiesi Clinical Trial Site 840141
      • DeLand、Florida、美国、32720
        • Chiesi Clinical Trial Site 840133
      • Doral、Florida、美国、33122
        • Chiesi Clinical Trial Site 840269
      • Hialeah、Florida、美国、33010
        • Chiesi Clinical Trial Site 840303
      • Hialeah、Florida、美国、33012
        • Chiesi Clinical Trial Site 840163
      • Hialeah、Florida、美国、33012
        • Chiesi Clinical Trial Site 840165
      • Hialeah、Florida、美国、33012
        • Chiesi Clinical Trial Site 840238
      • Hialeah、Florida、美国、33012
        • Chiesi Clinical Trial Site 840265
      • Hialeah、Florida、美国、33015
        • Chiesi Clinical Trial Site 840241
      • Hialeah、Florida、美国、33015
        • Chiesi Clinical Trial Site 840253
      • Hialeah、Florida、美国、33016
        • Chiesi Clinical Trial Site 840184
      • Hialeah、Florida、美国、33016
        • Chiesi Clinical Trial Site 840267
      • Hialeah Gardens、Florida、美国、33016
        • Chiesi Clinical Trial Site 840354
      • Hialeah Gardens、Florida、美国、33066
        • Chiesi Clinical Trial Site 840256
      • Kissimmee、Florida、美国、34741
        • Chiesi Clinical Trial Site 840200
      • Lakeland、Florida、美国、33803
        • Chiesi Clinical Trial Site 840232
      • Leesburg、Florida、美国、34748
        • Chiesi Clinical Trial Site 840113
      • Miami、Florida、美国、33122
        • Chiesi Clinical Trial Site 840372
      • Miami、Florida、美国、33125
        • Chiesi Clinical Trial Site 840137
      • Miami、Florida、美国、33125
        • Chiesi Clinical Trial Site 840289
      • Miami、Florida、美国、33125
        • Chiesi Clinical Trial Site 840377
      • Miami、Florida、美国、33125
        • Chiesi Clinical Trial Site 840387
      • Miami、Florida、美国、33126
        • Chiesi Clinical Trial Site 840326
      • Miami、Florida、美国、33133
        • Chiesi Clinical Trial Site 840175
      • Miami、Florida、美国、33133
        • Chiesi Clinical Trial Site 840346
      • Miami、Florida、美国、33134
        • Chiesi Clinical Trial Site 840347
      • Miami、Florida、美国、33135
        • Chiesi Clinical Trial Site 840205
      • Miami、Florida、美国、33135
        • Chiesi Clinical Trial Site 840247
      • Miami、Florida、美国、33135
        • Chiesi Clinical Trial Site 840341
      • Miami、Florida、美国、33144
        • Chiesi Clinical Trial Site 840148
      • Miami、Florida、美国、33144
        • Chiesi Clinical Trial Site 840239
      • Miami、Florida、美国、33144
        • Chiesi Clinical Trial Site 840312
      • Miami、Florida、美国、33144
        • Chiesi Clinical Trial Site 840355
      • Miami、Florida、美国、33144
        • Chiesi Clinical Trial Site 840388
      • Miami、Florida、美国、33155
        • Chiesi Clinical Trial Site 840237
      • Miami、Florida、美国、33155
        • Chiesi Clinical Trial Site 840261
      • Miami、Florida、美国、33155
        • Chiesi Clinical Trial Site 840262
      • Miami、Florida、美国、33155
        • Chiesi Clinical Trial Site 840280
      • Miami、Florida、美国、33165
        • Chiesi Clinical Trial Site 840178
      • Miami、Florida、美国、33165
        • Chiesi Clinical Trial Site 840292
      • Miami、Florida、美国、33166
        • Chiesi Clinical Trial Site 840202
      • Miami、Florida、美国、33169
        • Chiesi Clinical Trial Site 840275
      • Miami、Florida、美国、33173
        • Chiesi Clinical Trial Site 840122
      • Miami、Florida、美国、33173
        • Chiesi Clinical Trial Site 840352
      • Miami、Florida、美国、33174
        • Chiesi Clinical Trial Site 840235
      • Miami、Florida、美国、33174
        • Chiesi Clinical Trial Site 840360
      • Miami、Florida、美国、33174
        • Chiesi Clinical Trial Site 840381
      • Miami、Florida、美国、33175
        • Chiesi Clinical Trial Site 840243
      • Miami、Florida、美国、33175
        • Chiesi Clinical Trial Site 840244
      • Miami、Florida、美国、33175
        • Chiesi Clinical Trial Site 840257
      • Miami、Florida、美国、33175
        • Chiesi Clinical Trial Site 840380
      • Miami、Florida、美国、33175
        • Chiesi Clinical Trial Site 840382
      • Miami、Florida、美国、33176
        • Chiesi Clinical Trial Site 840367
      • Miami、Florida、美国、33186
        • Chiesi Clinical Trial Site 840162
      • Miami、Florida、美国、33186
        • Chiesi Clinical Trial Site 840166
      • Miami、Florida、美国、33186
        • Chiesi Clinical Trial Site 840370
      • Miami、Florida、美国、33186
        • Chiesi Clinical Trial Site 840392
      • Miami Beach、Florida、美国、33141
        • Chiesi Clinical Trial Site 840319
      • Miami Lakes、Florida、美国、33014
        • Chiesi Clinical Trial Site 840328
      • Miami Lakes、Florida、美国、33014
        • Chiesi Clinical Trial Site 840378
      • Miami Lakes、Florida、美国、33016
        • Chiesi Clinical Trial Site 840288
      • Miami Lakes、Florida、美国、33016
        • Chiesi Clinical Trial Site 840385
      • Miami Lakes、Florida、美国、33144
        • Chiesi Clinical Trial Site 840353
      • Mt. Dora、Florida、美国、32757
        • Chiesi Clinical Trial Site 840140
      • New Port Richey、Florida、美国、34652
        • Chiesi Clinical Trial Site 840263
      • North Miami、Florida、美国、33161
        • Chiesi Clinical Trial Site 840132
      • North Miami Beach、Florida、美国、33160
        • Chiesi Clinical Trial Site 840161
      • Orlando、Florida、美国、32807
        • Chiesi Clinical Trial Site 840255
      • Orlando、Florida、美国、32822
        • Chiesi Clinical Trial Site 840110
      • Orlando、Florida、美国、32825
        • Chiesi Clinical Trial Site 840125
      • Palmetto Bay、Florida、美国、33157
        • Chiesi Clinical Trial Site 840121
      • Pembroke Pines、Florida、美国、33024
        • Chiesi Clinical Trial Site 840196
      • Pembroke Pines、Florida、美国、33024
        • Chiesi Clinical Trial Site 840198
      • Plantation、Florida、美国、33317
        • Chiesi Clinical Trial Site 840363
      • Plantation、Florida、美国、33317
        • Chiesi Clinical Trial Site 840371
      • Pompano Beach、Florida、美国、33064
        • Chiesi Clinical Trial Site 840252
      • Port Charlotte、Florida、美国、33952
        • Chiesi Clinical Trial Site 840105
      • Sarasota、Florida、美国、34239
        • Chiesi Clinical Trial Site 840294
      • St. Petersburg、Florida、美国、33704
        • Chiesi Clinical Trial Site 840291
      • Tampa、Florida、美国、33607
        • Chiesi Clinical Trial Site 840313
      • Tampa、Florida、美国、33607
        • Chiesi Clinical Trial Site 840356
      • Tampa、Florida、美国、33607
        • Chiesi Clinical Trial Site 840379
      • Tampa、Florida、美国、33613
        • Chiesi Clinical Trial Site 840131
      • Tampa、Florida、美国、33614
        • Chiesi Clinical Trial Site 840324
      • Tampa、Florida、美国、33634
        • Chiesi Clinical Trial Site 840309
      • The Villages、Florida、美国、32162
        • Chiesi Clinical Trial Site 840210
      • Winter Park、Florida、美国、32789
        • Chiesi Clinical Trial Site 840129
    • Georgia
      • Adairsville、Georgia、美国、30103
        • Chiesi Clinical Trial Site 840223
      • Columbus、Georgia、美国、31904
        • Chiesi Clinical Trial Site 840218
      • Columbus、Georgia、美国、31904
        • Chiesi Clinical Trial Site 840414
      • Cordele、Georgia、美国、31015
        • Chiesi Clinical Trial Site 840437
      • Lawrenceville、Georgia、美国、30044
        • Chiesi Clinical Trial Site 840390
      • Lawrenceville、Georgia、美国、30046
        • Chiesi Clinical Trial Site 840227
      • Rincon、Georgia、美国、31326
        • Chiesi Clinical Trial Site 840138
      • Stonecrest、Georgia、美国、30038
        • Chiesi Clinical Trial Site 840417
      • Union City、Georgia、美国、30291
        • Chiesi Clinical Trial Site 840383
    • Illinois
      • Chicago、Illinois、美国、60602
        • Chiesi Clinical Trial Site 840321
      • Chicago Ridge、Illinois、美国、60415
        • Chiesi Clinical Trial Site 840365
    • Indiana
      • Hammond、Indiana、美国、46324
        • Chiesi Clinical Trial Site 840407
      • Valparaiso、Indiana、美国、76383
        • Chiesi Clinical Trial Site 840108
    • Iowa
      • Council Bluffs、Iowa、美国、51503
        • Chiesi Clinical Trial Site 840318
    • Louisiana
      • Crowley、Louisiana、美国、70526
        • Chiesi Clinical Trial Site 840207
      • Zachary、Louisiana、美国、70791
        • Chiesi Clinical Trial Site 840436
    • Maine
      • Bangor、Maine、美国、04401
        • Chiesi Clinical Trial Site 840451
    • Maryland
      • Baltimore、Maryland、美国、21237
        • Chiesi Clinical Trial Site 840447
      • Baltimore、Maryland、美国、21287
        • Chiesi Clinical Trial Site 840376
      • Westminster、Maryland、美国、21157
        • Chiesi Clinical Trial Site 840199
    • Massachusetts
      • Fall River、Massachusetts、美国、02723
        • Chiesi Clinical Trial Site 840214
      • New Bedford、Massachusetts、美国、02740
        • Chiesi Clinical Trial Site 840322
      • North Dartmouth、Massachusetts、美国、02747
        • Chiesi Clinical Trial site 840250
    • Michigan
      • Dearborn、Michigan、美国、48124
        • Chiesi Clinical Trial Site 840325
      • Dearborn、Michigan、美国、48126
        • Chiesi Clinical Trial Site 840400
      • Farmington Hills、Michigan、美国、48336
        • Chiesi Clinical Trial Site 840183
      • Flint、Michigan、美国、48504
        • Chiesi Clinical Trial Site 840340
      • Flint、Michigan、美国、48532
        • Chiesi Clinical Trial Site 840401
      • Novi、Michigan、美国、48375
        • Chiesi Clinical Trial Site 840345
      • Southfield、Michigan、美国、48034
        • Chiesi Clinical Trial Site 840287
      • Southfield、Michigan、美国、48075
        • Chiesi Clinical Trial Site 840415
    • Mississippi
      • Fayette、Mississippi、美国、39069
        • Chiesi Clinical Trial Site 840444
      • Ridgeland、Mississippi、美国、39157
        • Chiesi Clinical Trial Site 840448
    • Missouri
      • Chesterfield、Missouri、美国、63017
        • Chiesi Clinical Trial Site 840278
      • Columbia、Missouri、美国、65203
        • Chiesi Clinical Trial Site 840155
      • Richmond Heights、Missouri、美国、63117
        • Chiesi Clinical Trial Site 840316
      • Saint Charles、Missouri、美国、63301
        • Chiesi Clinical Trial Site 840150
      • St Louis、Missouri、美国、63123
        • Chiesi Clinical Trial Site 840282
      • St Louis、Missouri、美国、63141
        • Chiesi Clinical Trial Site 840123
      • St Louis、Missouri、美国、63141
        • Chiesi Clinical Trial Site 840142
    • Montana
      • Missoula、Montana、美国、59808
        • Chiesi Clinical Trial Site 840273
    • Nebraska
      • Lincoln、Nebraska、美国、68506
        • Chiesi Clinical Trial Site 840281
      • Omaha、Nebraska、美国、68114
        • Chiesi Clinical Trial Site 840329
    • Nevada
      • Las Vegas、Nevada、美国、840213
        • Chiesi Clinical Trial Site 840213
      • Las Vegas、Nevada、美国、89106
        • Chiesi Clinical Trial Site 840285
      • Las Vegas、Nevada、美国、89123
        • Chiesi Clinical Trial Site 840299
    • New Hampshire
      • Portsmouth、New Hampshire、美国、03810
        • Chiesi Clinical Trial Site 840338
    • New Jersey
      • Berlin、New Jersey、美国、08009
        • Chiesi Clinical Trial Site 840297
      • Toms River、New Jersey、美国、08755
        • Chiesi Clinical Trial Site 840333
    • New York
      • Binghamton、New York、美国、13905
        • Chiesi Clinical Trial Site 840330
      • Brooklyn、New York、美国、11235
        • Chiesi Clinical Trial Site 840397
      • Buffalo、New York、美国、14201
        • Chiesi Clinical Trial Site 840254
      • Buffalo、New York、美国、14203
        • Chiesi Clinical Trial Site 840307
      • Flushing、New York、美国、11355
        • Chiesi Clinical Trial Site 840368
      • New Windsor、New York、美国、12553
        • Chiesi Clinical Trial Site 840362
      • The Bronx、New York、美国、10455
        • Chiesi Clinical Trial Site 840128
    • North Carolina
      • Charlotte、North Carolina、美国、28207
        • Chiesi Clinical Trial Site 840215
      • Charlotte、North Carolina、美国、28210
        • Chiesi Clinical Trial Site 840366
      • Charlotte、North Carolina、美国、28277
        • Chiesi Clinical Trial Site 840158
      • Denver、North Carolina、美国、28037
        • Chiesi Clinical Trial Site 840409
      • Durham、North Carolina、美国、27705
        • Chiesi Clinical Trial Site 840403
      • Gastonia、North Carolina、美国、28054
        • Chiesi Clinical Trial Site 840428
      • Huntersville、North Carolina、美国、28078
        • Chiesi Clinical Trial Site 840236
      • Monroe、North Carolina、美国、28112
        • Chiesi Clinical Trial Site 840259
      • Morgantown、North Carolina、美国、28655
        • Chiesi Clinical Trial Site 840440
      • New Bern、North Carolina、美国、28562
        • Chiesi Clinical Trial Site 840194
      • Raleigh、North Carolina、美国、27607
        • Chiesi Clinical Trial Site 840120
      • Raleigh、North Carolina、美国、27607
        • Chiesi Clinical Trial Site 840438
      • Raleigh、North Carolina、美国、27617
        • Chiesi Clinical Trial Site 840429
      • Rocky Mount、North Carolina、美国、27804
        • Chiesi Clinical Trial Site 840112
      • Shelby、North Carolina、美国、28150
        • Chiesi Clinical Trial Site 840135
      • Wilmington、North Carolina、美国、28403
        • Chiesi Clinical Trial Site 840189
      • Winston-Salem、North Carolina、美国、27103
        • Chiesi Clinical Trial Site 840412
    • Ohio
      • Akron、Ohio、美国、44313
        • Chiesi Clinical Trial Site 840445
      • Cincinnati、Ohio、美国、45231
        • Chiesi Clinical Trial Site 840104
      • Cincinnati、Ohio、美国、45242
        • Chiesi Clinical Trial Site 840357
      • Columbus、Ohio、美国、43215
        • Chiesi Clinical Trial Site 840124
      • Dayton、Ohio、美国、45424
        • Chiesi Clinical Trial Site 840426
      • Kettering、Ohio、美国、45439
        • Chiesi Clinical Trial Site 840302
      • Maumee、Ohio、美国、43537
        • Chiesi Clinical Trial Site 840233
      • Middleburg Heights、Ohio、美国、44130
        • Chiesi Clinical Trial Site 840167
      • Toledo、Ohio、美国、43617
        • Chiesi Clinical Trial Site 840157
    • Oregon
      • Medford、Oregon、美国、97504
        • Chiesi Clinical Trial Site 840203
    • Pennsylvania
      • Beaver、Pennsylvania、美国、15009
        • Chiesi Clinical Trial Site 840300
      • DuBois、Pennsylvania、美国、15801
        • Chiesi Clinical Trial Site 840308
      • Jenkintown、Pennsylvania、美国、19046
        • Chiesi Clinical Trial Site 840156
      • Pittsburgh、Pennsylvania、美国、15236
        • Chiesi Clinical Trial Site 840327
      • Scotland、Pennsylvania、美国、15683
        • Chiesi Clinical Trial Site 840418
      • Smithfield、Pennsylvania、美国、15478
        • Chiesi Clinical Trial Site 840419
    • Rhode Island
      • Cranston、Rhode Island、美国、02920
        • Chiesi Clinical Trial Site 840450
      • Cumberland、Rhode Island、美国、02864
        • Chiesi Clinical Trial Site 840332
    • South Carolina
      • Anderson、South Carolina、美国、29621
        • Chiesi Clinical Trial Site 840222
      • Anderson、South Carolina、美国、29621
        • Chiesi Clinical Trial Site 840435
      • Charleston、South Carolina、美国、29406
        • Chiesi Clinical Trial Site 840431
      • Columbia、South Carolina、美国、29201
        • Chiesi Clinical Trial Site 840334
      • Columbia、South Carolina、美国、29204
        • Chiesi Clinical Trial Site 840130
      • Columbia、South Carolina、美国、29223
        • Chiesi Clinical Trial Site 840430
      • Fort Mill、South Carolina、美国、29707
        • Chiesi Clinical Trial Site 840211
      • Gaffney、South Carolina、美国、29340
        • Chiesi Clinical Trial Site 840182
      • Greenville、South Carolina、美国、29615
        • Chiesi Clinical Trial Site 840111
      • Lancaster、South Carolina、美国、29720
        • Chiesi Clinical Trial Site 840420
      • Mauldin、South Carolina、美国、29662
        • Chiesi Clinical Trial Site 840386
      • Rock Hill、South Carolina、美国、29732
        • Chiesi Clinical Trial Site 840100
      • Spartanburg、South Carolina、美国、29303
        • Chiesi Clinical Trial Site 840375
      • Union、South Carolina、美国、29379
        • Chiesi Clinical Trial Site 840106
      • West Columbia、South Carolina、美国、29169
        • Chiesi Clinical Trial Site 840295
    • South Dakota
      • Rapid City、South Dakota、美国、57702
        • Chiesi Clinical Trial Site 840398
    • Tennessee
      • Chattanooga、Tennessee、美国、37404
        • Chiesi Clinical Trial Site 840305
      • Franklin、Tennessee、美国、37067
        • Chiesi Clinical Trial Site 840351
      • Johnson City、Tennessee、美国、37601
        • Chiesi Clinical Trial Site 840306
      • Knoxville、Tennessee、美国、37909
        • Chiesi Clinical Trial Site 840171
      • Nashville、Tennessee、美国、37203
        • Chiesi Clinical Trial Site 840361
      • Tullahoma、Tennessee、美国、37388
        • Chiesi Clinical Trial Site 840271
    • Texas
      • Baytown、Texas、美国、77521
        • Chiesi Clinical Trial Site 840101
      • Boerne、Texas、美国、78006
        • Chiesi Clinical Trial Site 840114
      • Cypress、Texas、美国、77429
        • Chiesi Clinical Trial Site 840146
      • Dallas、Texas、美国、75230
        • Chiesi Clinical Trial Site 840413
      • Houston、Texas、美国、77008
        • Chiesi Clinical Trial Site 840284
      • Houston、Texas、美国、77008
        • Chiesi Clinical Trial Site 840411
      • Houston、Texas、美国、77030
        • Chiesi Clinical Trial Site 840389
      • Houston、Texas、美国、77084
        • Chiesi Clinical Trial Site 840185
      • Houston、Texas、美国、77098
        • Chiesi Clinical Trial Site 840224
      • Humble、Texas、美国、77396
        • Chiesi Clinical Trial Site 840408
      • Katy、Texas、美国、77494
        • Chiesi Clinical Trial Site 840102
      • Katy、Texas、美国、77494
        • Chiesi Clinical Trial Site 840274
      • Kerrville、Texas、美国、78028
        • Chiesi Clinical Trial Site 840432
      • Lampasas、Texas、美国、76550
        • Chiesi Clinical Trial Site 840160
      • McAllen、Texas、美国、78503
        • Chiesi Clinical Trial Site 840424
      • McKinney、Texas、美国、75069
        • Chiesi Clinical Trial Site 840119
      • Nederland、Texas、美国、77627
        • Chiesi Clinical Trial Site 840442
      • North Richland Hills、Texas、美国、76180
        • Chiesi Clinical Trial Site 840176
      • Pearland、Texas、美国、77584
        • Chiesi Clinical Trial Site 840283
      • San Antonio、Texas、美国、78063
        • Chiesi Clinical Trial Site 840191
      • San Antonio、Texas、美国、78215
        • Chiesi Clinical Trial Site 840320
      • San Antonio、Texas、美国、78229
        • Chiesi Clinical Trial Site 840410
      • Sherman、Texas、美国、75092
        • Chiesi Clinical Trial Site 840231
      • Sherman、Texas、美国、75092
        • Chiesi Clinical Trial Site 840396
      • Splendora、Texas、美国、77372
        • Chiesi Clinical Trial Site 840394
      • Sugar Land、Texas、美国、77479
        • Chiesi Clinical Trial Site 840221
      • Tomball、Texas、美国、77375
        • Chiesi Clinical Trial Site 840139
      • Tomball、Texas、美国、77375
        • Chiesi Clinical Trial Site 840314
    • Vermont
      • Colchester、Vermont、美国、05446
        • Chiesi Clinical Trial Site 840337
    • Virginia
      • Manassas、Virginia、美国、20110
        • Chiesi Clinical Trial Site 840264
      • Richmond、Virginia、美国、23219
        • Chiesi Clinical Trial Site 840159
      • Richmond、Virginia、美国、23226
        • Chiesi Clinical Trial Site 840425
    • Washington
      • Everett、Washington、美国、98208
        • Chiesi Clinical Trial Site 840423
      • Renton、Washington、美国、98055
        • Chiesi Clinical Trial Site 840342
      • Vancouver、Washington、美国、98664
        • Chiesi Clinical Trial Site 840154
    • West Virginia
      • Kingwood、West Virginia、美国、26537
        • Chiesi Clinical Trial Site 840421
      • Morgantown、West Virginia、美国、26505
        • Chiesi Clinical Trial Site 840201
  • 阿根廷
      • Buenos Aires、阿根廷、1407
        • Chiesi Clinical Trial Site 032125
      • Buenos Aires、阿根廷、C1425FVH
        • Chiesi Clinical Trial Site 032130
      • Buenos Aires、阿根廷
        • Chiesi Clinical Trial Site 032133
      • Ciudad Autonoma de Buenos Aire、阿根廷、1430
        • Chiesi Clinical Trial Site 032103
      • Ciudad Autonoma de Buenos Aire、阿根廷、B1602DOH
        • Chiesi Clinical Trial Site 032109
      • Córdoba、阿根廷、5000
        • Chiesi Clinical Trial Site 032122
      • Lobos、阿根廷、7240
        • Chiesi Clinical Trial Site 032131
      • Mar del Plata、阿根廷、7600
        • Chiesi Clinical Trial Site 032119
      • Mendoza、阿根廷、5500
        • Chiesi Clinical Trial Site 032105
      • Mendoza、阿根廷、5500
        • Chiesi Clinical Trial Site 032129
      • Mendoza、阿根廷、M5502IDE
        • Chiesi Clinical Trial Site 032126
      • Paraná、阿根廷、3100
        • Chiesi Clinical Trial Site 032123
      • Rosario、阿根廷、S2002OJN
        • Chiesi Clinical Trial Site 032128
      • San Miguel de Tucumán、阿根廷、4000
        • Chiesi Clinical Trial Site 032134
      • San Miguel de Tucumán、阿根廷、4000
        • Chiesi Clinical Trial Site 032136
      • San Rafael、阿根廷、5600
        • Chiesi Clinical Trial Site 032127
      • Santa Fe、阿根廷、3000
        • Chiesi Clinical Trial Site 032124
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aire、Buenos Aires、阿根廷、1056ABJ
        • Chiesi Clinical Trial Site 032115
      • Ciudad Autonoma de Buenos Aire、Buenos Aires、阿根廷、1426
        • Chiesi Clinical Trial Site 032113
      • Ciudad Autonoma de Buenos Aire、Buenos Aires、阿根廷、B1837
        • Chiesi Clinical Trial Site 032107
      • Ciudad Autonoma de Buenos Aire、Buenos Aires、阿根廷、C1426ABO
        • Chiesi Clinical Trial Site 032112
      • Ciudad Autonoma de Buenos Aire、Buenos Aires、阿根廷、Cl425DTG
        • Chiesi Clinical Trial Site 032121
      • La Plata、Buenos Aires、阿根廷、1900
        • Chiesi Clinical Trial Site 032108
      • Mar del Plata、Buenos Aires、阿根廷、3168
        • Chiesi Clinical Trial Site 032118
      • Mar del Plata、Buenos Aires、阿根廷、B7600FZO
        • Chiesi Clinical Trial Site 032114
      • Monte Grande、Buenos Aires、阿根廷、1842
        • Chiesi Clinical Trial Site 032102
      • Quilmes、Buenos Aires、阿根廷、B1878FNR
        • Chiesi Clinical Trial Site 032106
      • San Fernando、Buenos Aires、阿根廷、1646
        • Chiesi Clinical Trial Site 032116
      • San Juan Bautista、Buenos Aires、阿根廷、B1853AIK
        • Chiesi Clinical Trial Site 032110
      • Vicente López、Buenos Aires、阿根廷、1602
        • Chiesi Clinical Trial Site 032100
    • Córdoba Province
      • Córdoba、Córdoba Province、阿根廷、X5008HHW
        • Chiesi Clinical Trial Site 032111
    • Entre Ríos Province
      • Concepción del Uruguay、Entre Ríos Province、阿根廷、E3260EPD
        • Chiesi Clinical Trial Site 032120
    • Santa Fe Province
      • Rosario、Santa Fe Province、阿根廷、2000
        • Chiesi Clinical Trial Site 032101
      • Rosario、Santa Fe Province、阿根廷、S2121
        • Chiesi Clinical Trial Site 032132
    • Tucumán Province
      • San Miguel de Tucumán、Tucumán Province、阿根廷、T4000
        • Chiesi Clinical Trial Site 032117

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

40年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Signed and dated written informed consent must be obtained prior to initiating any study-related procedures

  • Outpatient

  • Male or female subjects aged ≥40 years

  • Female subjects:

    1. WOCBP fulfilling one of the following criteria: i. WOCBP with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method from the signing of the informed consent form and until the follow-up contact or ii. WOCBP with non-fertile male partners (contraception is not required in this case).
    2. Female subjects of non-childbearing potential defined as physiologically incapable of becoming pregnant (i.e. post-menopausal or permanently sterile as per definitions given in Appendix 5). Tubal ligation or partial surgical interventions are not acceptable. If indicated, as per investigator's request, post-menopausal status may be confirmed by follicle-stimulating hormone levels (according to local laboratory ranges)

  • COPD diagnosis for at least 12 months before the screening visit in accordance with the definition by the GOLD 2020 Report

  • Current or ex-smokers who quit smoking at least 6 months prior to screening with a smoking history of at least 10 pack-years [pack-years = (number of cigarettes per day x number of years)/20]

  • COPD Assessment Test (CAT) score ≥10

  • A pre- and post-bronchodilator FEV1/FVC ratio <0.70 at screening

  • A post-bronchodilator FEV1 <50% predicted normal at screening and a documented history of ≥1 moderate or severe COPD exacerbation in the previous 12 months OR a post-bronchodilator FEV1 ≥50% and <80% of predicted normal at screening and a documented history of ≥2 moderate COPD exacerbations or ≥1 severe COPD exacerbation in the previous 12 months

  • Subjects receiving daily inhaled maintenance therapy for their COPD, at a stable dose for at least 3 months prior to the screening and randomization visits

  • Documentation (including imagery and report) of chest x-ray (CXR) or CT scan performed within 6 months prior to the screening visit, without evidence of significant abnormalities (other than those related to the presence of COPD).

  • A cooperative attitude and ability to demonstrate correct use of the pMDI inhalers and eDiary.

Exclusion Criteria:

  • Female subjects who are pregnant (as evident by a positive urine hCG or serum β-hCG test) or lactating

  • Subjects using the following medications prior to the screening visit and during the run-in period:

    1. Systemic/oral/parenteral corticosteroids in the prior 4 weeks
    2. Use of antibiotics for a lower respiratory tract infection (e.g. pneumonia) or COPD exacerbation in the prior 4 weeks
    3. Any long-term chronic maintenance use of antibiotic treatment in the prior 4 weeks
    4. Oral xanthine derivatives (e.g. theophylline) in the prior 7 days

  • A moderate or severe COPD exacerbation or a respiratory tract infection (e.g., pneumonia) that has not resolved ≤14 days prior to the screening visit or during the run-in period

  • Current treatment with non-cardioselective β-blockers

  • Requirement of long term (> 15 hours daily) oxygen therapy

  • Known respiratory disorders other than COPD which may impact the efficacy of the study drug according to investigator's judgement.

  • Lung transplant surgery or lung volume reduction surgery (subjects with lung volume reduction surgery are excluded if the procedure was performed within 1 year before the Screening visit)

  • Medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the investigator, would prevent use of anticholinergic agents

  • History of hypersensitivity to M3 receptor antagonists, β2 agonists, corticosteroids or any of the excipients contained in any of the study drugs used in the trial which may raise contra-indications or impact the efficacy of the study drug according to the investigator's judgement

  • Subject has severe, acute or uncontrolled cardiovascular condition (such as but not limited to unstable ischemic heart disease, NYHA Class IV, left ventricular failure, acute myocardial infarction or unstable angina) in the last 6 months

  • An abnormal and clinically significant 12-lead ECG at either the screening or randomization visit. This is characterized as but not limited to any of the following findings:

    1. Atrial fibrillation (AF) with rapid ventricular response > 120 bpm
    2. Ventricular tachycardias (sustained, non-sustained [>3 up to 30 sec])
    3. Evidence of Mobitz Type II second degree or third-degree atrioventricular block
    4. Prolonged QTcF (>450ms for males, or >470ms for females). This criterion is not applicable for subjects with a pacemaker or permanent AF.

  • Clinically significant laboratory abnormalities indicating a significant or unstable concomitant disease which may impact the efficacy or the safety of the study drug according to investigator's judgement

  • Unstable or uncontrolled concurrent disease which may impact the efficacy or safety of the study drug or the subject's participation in the study according to investigator's judgment

  • Malignancy that has not been in complete remission for at least 1 year or any untreated localized carcinomas

  • History of alcohol abuse and/or substance/drug abuse within 12 months prior to the screening visit

  • Receipt of any other investigational drug within 1 month or 5 half-lives (whichever is greater) prior to the screening visit or have been previously randomized in this trial, or are currently participating in another clinical trial

  • Currently in the acute phase of a pulmonary rehabilitation program within 4 weeks before the screening visit or planning to enroll in the acute phase of such a program during the study. Subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded

  • Mentally or legally incapacitated, or subjects incarcerated as a result of an official or judicial order

  • Major surgery in the 3 months prior to the screening visit or have a planned surgery during the trial

  • Non-satisfactory compliance with the eDiary (<65% or >135%) during the run-in period

  • Subjects requiring the use of spacer device or nebulizer for administration of maintenance COPD therapies.

  • Veins unsuitable for repeat venipuncture

  • Blood donation or blood loss (≥450mL) in the 4 weeks before randomization

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：BDP/FF/GB - CHF 5993

Two inhalations twice daily of BDP/FF/GB (100/6/12.5μg) for a period of 52 weeks via pressurized metered dose inhaler
药品：Beclomethasone Dipropionate

Available in pressurized inhalation solution BDP/FF/GB 100/6/12.5μg and BDP/FF 100/6μg

其他名称：
  • 开发计划署
药品：Glycopyrronium Bromide

Available in pressurized inhalation solution BDP/FF/GB 100/6/12.5μg

其他名称：
  • 格隆溴铵
  • 国标
药品：Formoterol Fumarate

Available in pressurized inhalation solution BDP/FF/GB 100/6/12.5μg and BDP/FF 100/6μg

其他名称：
  • FF
有源比较器：BDP/FF - CHF 1535

Two inhalations twice daily of BDP/FF (100/6μg) for a period of 52 weeks via pressurized metered dose inhaler
药品：Beclomethasone Dipropionate

Available in pressurized inhalation solution BDP/FF/GB 100/6/12.5μg and BDP/FF 100/6μg

其他名称：
  • 开发计划署
药品：Formoterol Fumarate

Available in pressurized inhalation solution BDP/FF/GB 100/6/12.5μg and BDP/FF 100/6μg

其他名称：
  • FF

研究衡量的是什么？

主要结果指标

结果测量
大体时间
第 28 周第 1 秒用力呼气量 (FEV1) 给药前早晨相对于基线的变化
大体时间：第 28 周
第 28 周

次要结果测量

结果测量
措施说明
大体时间
第 28 周给药后 2 小时早晨 FEV1 相对于基线的变化
大体时间：第 28 周
第 28 周
指定门诊就诊时服药前早晨 FEV1 相对于基线的变化
大体时间：第 4 周、第 10 周、第 40 周和第 52 周
第 4 周、第 10 周、第 40 周和第 52 周
给药后 2 小时早晨 FEV1 指定门诊就诊相对于基线的变化
大体时间：第 1 天、第 4 周、第 10 周、第 40 周和第 52 周
第 1 天、第 4 周、第 10 周、第 40 周和第 52 周
在指定的门诊就诊时从给药前到给药后 2 小时早晨 FEV1 的变化
大体时间：第 1 天、第 4 周、第 10 周、第 28 周、第 40 周和第 52 周
第 1 天、第 4 周、第 10 周、第 28 周、第 40 周和第 52 周
在指定的门诊就诊时 FEV1 反应（给药前早上 FEV1 与基线相比的变化≥100ml）
大体时间：第 1 天、第 4 周、第 10 周、第 28 周、第 40 周和第 52 周
第 1 天、第 4 周、第 10 周、第 28 周、第 40 周和第 52 周
首次中度或重度 COPD 恶化的时间
大体时间：52周治疗期
52周治疗期
首次严重 COPD 恶化的时间
大体时间：52周治疗期
52周治疗期
指定门诊就诊时圣乔治呼吸问卷 (SGRQ) 反应（总分较基线下降≥4）
大体时间：第 4 周、第 10 周、第 28 周、第 40 周和第 52 周
第 4 周、第 10 周、第 28 周、第 40 周和第 52 周
每次指定门诊就诊时 SGRQ 总分和领域分数相对于基线的变化
大体时间：第 4 周、第 10 周、第 28 周、第 40 周和第 52 周
第 4 周、第 10 周、第 28 周、第 40 周和第 52 周
在指定门诊就诊时给药前早晨用力肺活量 (FVC) 相对于基线的变化
大体时间：第 4 周、第 10 周、第 28 周、第 40 周和第 52 周
第 4 周、第 10 周、第 28 周、第 40 周和第 52 周
在指定的门诊就诊时从给药前到给药后 2 小时早晨 FVC 的变化
大体时间：第 1 天、第 4 周、第 10 周、第 28 周、第 40 周和第 52 周
第 1 天、第 4 周、第 10 周、第 28 周、第 40 周和第 52 周
指定门诊就诊时的 CAT 反应（从基线下降 ≥ 2 分）
大体时间：第 4 周、第 10 周、第 28 周、第 40 周和第 52 周
第 4 周、第 10 周、第 28 周、第 40 周和第 52 周
在 52 周的治疗期间，健康相关生活质量相对于基线的变化（总 SGRQ 评分相对于基线下降≥4）。
大体时间：52周治疗期
52周治疗期
Rate of moderate and severe COPD exacerbations over 52 weeks of treatment
大体时间：52-week treatment period

Annualized rate of moderate and severe COPD exacerbations as observed during the 52-week study treatment period.
52-week treatment period
Rate of severe COPD exacerbations over 52 weeks of treatment
大体时间：52-week treatment period

Annualized rate of severe COPD exacerbations as observed during 52-week treatment period
52-week treatment period
Change from baseline to each inter-visit period in the percentage of days without intake of rescue medication
大体时间：Day 1-Week 4, Week 4-Week 10, Week 10-Week 28, Week 28-Week 40, Week 40-Week 52

Change from baseline (defined as the 2-week run-in period prior to randomization) to each inter-visit period (defined as the period of time between designated clinic visits) in percentage of days without rescue medication
Day 1-Week 4, Week 4-Week 10, Week 10-Week 28, Week 28-Week 40, Week 40-Week 52
Change from baseline to each inter-visit period in the average use of rescue medication (number of puffs/day)
大体时间：Day 1-Week 4, Week 4-Week 10, Week 10-Week 28, Week 28-Week 40, Week 40-Week 52

Change from baseline (defined as the 2-week run-in period prior to randomization) in the average number of puffs per day of rescue medication for each inter-visit period (defined as the period of time between designated clinic visits).
Day 1-Week 4, Week 4-Week 10, Week 10-Week 28, Week 28-Week 40, Week 40-Week 52
Change from baseline in 2-hour post-dose morning FVC at designated clinic visits
大体时间：Day 1, Week 4, Week 10, Week 28, Week 40, & Week 52

Change from baseline (defined as the pre-dose value on Day 1) in 2-hour post-dose morning FVC at designated clinic visits
Day 1, Week 4, Week 10, Week 28, Week 40, & Week 52
Change from baseline to each inter-visit period in the average E-RS total score and domain scores
大体时间：Day 1-Week 4, Week 4-Week 10, Week 10-Week 28, Week 28-Week 40, Week 40-Week 52

Change from baseline (defined as the 2-week run-in period prior to randomization) in the average E-RS total score and E-RS domain scores for the period of time between designated clinic visits.
Day 1-Week 4, Week 4-Week 10, Week 10-Week 28, Week 28-Week 40, Week 40-Week 52
Change from baseline in COPD Assessment Test (CAT) score at designated clinic visit
大体时间：Week 4, Week 10, Week 28, Week 40, & Week 52

The CAT is composed of 8 questions to measure the impact of COPD on daily life, which are scored from 0 to 5 with higher scores reflecting greater impact.
Week 4, Week 10, Week 28, Week 40, & Week 52
Modified Medical Research Council (mMRC) dyspnea scale at designated clinic visits
大体时间：Day 1, Week 4, Week 10, Week 28, Week 40, & Week 52

Descriptive statistics of the mMRC dyspnea scale score at designated clinic visits. The mMRC dyspnea scale is graded from 0 to 4, with higher grades reflecting greater severity.
Day 1, Week 4, Week 10, Week 28, Week 40, & Week 52

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：Thomas Siler, MD、Midwest Chest Consultants

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)

2022年4月27日

初级完成 (实际的)

2026年1月12日

研究完成 (实际的)

2026年1月12日

研究注册日期

首次提交

2020年3月23日

首先提交符合 QC 标准的

2020年3月23日

首次发布 (实际的)

2020年3月25日

研究记录更新

最后更新发布 (实际的)

2026年9月21日

上次提交的符合 QC 标准的更新

2026年9月17日

最后验证

2026年9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

  • CLI-05993AA3-06
  • 2020-002389-16 (EudraCT编号)
  • 2023 (美国 NIH 拨款/合同)
  • 2023-510172-31-00 (克蒂斯)

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 共享访问标准

Chiesi clinical data sharing scope, process and data access criteria is available on the Chiesi Group website.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

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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