COPD 환자에서 고정 용량 3중 조합 CHF 5993과 고정 용량 이중 조합 CHF 1535의 효능, 안전성 및 내약성을 비교하는 연구 (TRITON)
2026년 9월 17일 업데이트: Chiesi Farmaceutici S.p.A.
Beclomethasone Dipropionate + Formoterol Fumarate + Glycopyrronium Bromide(CHF 5993)의 고정 용량 3중 조합의 효능, 안전성 및 내약성을 비교하는 III상, 52주, 다국적, 다기관, 무작위, 이중 맹검, 2군 병렬 그룹 연구 베클로메타손 디프로피오네이트 + 포르모테롤 푸마레이트(CHF 1535)의 고정 용량 이중 조합, 둘 다 만성 폐쇄성 폐질환(COPD)을 앓는 피험자에서 pMDI를 통해 투여됨
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.
연구 개요
상태
완전한
상세 설명
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.
연구 유형
중재적
등록 (실제)
3406
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Bacau, 루마니아, 600252
- Chiesi Clinical Trial Site 642109
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Bragadiru, 루마니아, 077025
- Chiesi Clinical Trial Site 642106
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Brasov, 루마니아, 500283
- Chiesi Clinical Trial Site 642117
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Bucharest, 루마니아, 020125
- Chiesi Clinical Trial Site 642103
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Bucharest, 루마니아, 11025
- Chiesi Clinical Trial Site 642113
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Bucharest, 루마니아, 012071
- Chiesi Clinical Trial Site 642108
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Caracal, 루마니아, 235200
- Chiesi Clinical Trial Site 642115
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Cluj-Napoca, 루마니아, 400275
- Chiesi Clinical Trial Site 642111
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Constanța, 루마니아, 900433
- Chiesi Clinical Trial Site 642105
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Craiova, 루마니아, 200515
- Chiesi Clinical Trial Site 642110
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Craiova, 루마니아, 200515
- Chiesi Clinical Trial Site 642118
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Iași, 루마니아, 700141
- Chiesi Clinical Trial Site 642101
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Reșca, 루마니아, 237143
- Chiesi Clinical Trial Site 642114
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Satu Mare, 루마니아, 44055
- Chiesi Clinical Trial Site 642112
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Timișoara, 루마니아, 300134
- Chiesi Clinical Trial Site 642116
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Bihor County
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Oradea, Bihor County, 루마니아, 410169
- Chiesi Clinical Trial Site 642102
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Cluj
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Cluj-Napoca, Cluj, 루마니아, 400371
- Chiesi Clinical Trial Site 642104
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Hunedoara County
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Deva, Hunedoara County, 루마니아, 330162
- Chiesi Clinical Trial Site 642120
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Ilfov
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Bragadiru, Ilfov, 루마니아, 077025
- Chiesi Clinical Trial Site 642107
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Timiș County
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Timișoara, Timiș County, 루마니아, 300336
- Chiesi Clinical Trial Site 642119
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Chihuahua City, 멕시코, 31217
- Chiesi Clinical Trial Site 484116
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Chihuahua City, 멕시코
- Chiesi Clinical Trial Site 484105
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Chihuahua City, 멕시코
- Chiesi Clinical Trial Site 484109
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Tlalpan, 멕시코
- Chiesi Clinical Trial Site 484108
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Estado de Baja California
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Tijuana, Estado de Baja California, 멕시코
- Chiesi Clinical Trial Site 484110
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Jalisco
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Guadalajara, Jalisco, 멕시코, 44610
- Chiesi Clinical Trial Site 484113
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Guadalajara, Jalisco, 멕시코
- Chiesi Clinical Trial Site 484100
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Guadalajara, Jalisco, 멕시코
- Chiesi Clinical Trial Site 484102
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Guadalajara, Jalisco, 멕시코
- Chiesi Clinical Trial Site 484104
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Guadalajara, Jalisco, 멕시코
- Chiesi Clinical Trial Site 484106
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Guadalajara, Jalisco, 멕시코
- Chiesi Clinical Trial Site 484112
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Guadalupe, Jalisco, 멕시코, 44200
- Chiesi Clinical Trial Site 484115
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Mexico City
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Cuauhtémoc, Mexico City, 멕시코
- Chiesi Clinical Trial Site 484103
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Michoacán
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Morelia, Michoacán, 멕시코
- Chiesi Clinical Trial Site 484107
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Nuevo León
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Monterrey, Nuevo León, 멕시코
- Chiesi Clinical Trial Site 484101
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Monterrey, Nuevo León, 멕시코
- Chiesi Clinical Trial Site 484111
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Alabama
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Birmingham, Alabama, 미국, 35215-7502
- Chiesi Clinical Trial Site 840350
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Dothan, Alabama, 미국, 36303
- Chiesi Clinical Trial Site 840186
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Foley, Alabama, 미국, 36535
- Chiesi Clinical Trial Site 840258
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Jasper, Alabama, 미국, 35501
- Chiesi Clinical Trial Site 840279
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Mobile, Alabama, 미국, 36608
- Chiesi Clinical Trial Site 840433
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Montgomery, Alabama, 미국, 36106
- Chiesi Clinical Trial Site 840206
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Muscle Shoals, Alabama, 미국, 35661
- Chiesi Clinical Trial Site 840249
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Arizona
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Chandler, Arizona, 미국, 85224
- Chiesi Clinical Trial Site 840406
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Peoria, Arizona, 미국, 85381
- Chiesi Clinical Trial Site 840402
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Tucson, Arizona, 미국, 85741
- Chiesi Clinical Trial Site 840349
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California
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Covina, California, 미국, 91723
- Chiesi Clinical Trial Site 840404
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Escondido, California, 미국, 92025
- Chiesi Clinical Trial Site 840209
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La Palma, California, 미국, 90623
- Chiesi Clinical Trial Site 840427
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Lomita, California, 미국, 90717
- Chiesi Clinical Trial Site 840358
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Newport Beach, California, 미국, 92663
- Chiesi Clinical Trial Site 840173
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Northridge, California, 미국, 91324
- Chiesi Clinical Trial Site 840208
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Northridge, California, 미국, 91324
- Chiesi Clinical Trial Site 840277
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Redding, California, 미국, 96001
- Chiesi Clinical Trial Site 840364
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Sacramento, California, 미국, 95821
- Chiesi Clinical Trial Site 840226
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Sacramento, California, 미국, 95823
- Chiesi Clinical Trial Site 840405
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San Diego, California, 미국, 92120
- Chiesi Clinical Trial Site 840107
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Santa Ana, California, 미국, 92705
- Chiesi Clinical Trial Site 840373
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Upland, California, 미국, 91786
- Chiesi Clinical Trial Site 840164
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West Covina, California, 미국, 91790
- Chiesi Clinical Trial Site 840174
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Westminster, California, 미국, 92683
- Chiesi Clinical Trial Site 840144
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Colorado
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Aurora, Colorado, 미국, 80014
- Chiesi Clinical Trial Site 840441
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Boulder, Colorado, 미국, 80302
- Chiesi Clinical Trial Site 840229
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Connecticut
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Norwalk, Connecticut, 미국, 06586
- Chiesi Clinical Trial Site 840399
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Florida
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Altamonte Springs, Florida, 미국, 32701
- Chiesi Clinical Trial Site 840116
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Aventura, Florida, 미국, 33180
- Chiesi Clinical Trial Site 840268
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Brandon, Florida, 미국, 33511
- Chiesi Clinical Trial Site 840192
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Brooksville, Florida, 미국, 34613
- Chiesi Clinical Trial Site 840310
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Chiefland, Florida, 미국, 32626
- Chiesi Clinical Trial Site 840240
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Clearwater, Florida, 미국, 33756
- Chiesi Clinical Trial Site 840153
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Coral Gables, Florida, 미국, 33134
- Chiesi Clinical Trial Site 840272
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Coral Gables, Florida, 미국, 33134
- Chiesi Clinical Trial Site 840304
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Cutler Bay, Florida, 미국, 33157
- Chiesi Clinical Trial Site 840193
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Cutler Bay, Florida, 미국, 33189
- Chiesi Clinical Trial Site 840311
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Cutler Bay, Florida, 미국, 33189
- Chiesi Clinical Trial Site 840335
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Daytona Beach, Florida, 미국, 32117
- Chiesi Clinical Trial Site 840141
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DeLand, Florida, 미국, 32720
- Chiesi Clinical Trial Site 840133
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Doral, Florida, 미국, 33122
- Chiesi Clinical Trial Site 840269
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Hialeah, Florida, 미국, 33010
- Chiesi Clinical Trial Site 840303
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Hialeah, Florida, 미국, 33012
- Chiesi Clinical Trial Site 840163
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Hialeah, Florida, 미국, 33012
- Chiesi Clinical Trial Site 840165
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Hialeah, Florida, 미국, 33012
- Chiesi Clinical Trial Site 840238
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Hialeah, Florida, 미국, 33012
- Chiesi Clinical Trial Site 840265
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Hialeah, Florida, 미국, 33015
- Chiesi Clinical Trial Site 840241
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Hialeah, Florida, 미국, 33015
- Chiesi Clinical Trial Site 840253
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Hialeah, Florida, 미국, 33016
- Chiesi Clinical Trial Site 840184
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Hialeah, Florida, 미국, 33016
- Chiesi Clinical Trial Site 840267
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Hialeah Gardens, Florida, 미국, 33016
- Chiesi Clinical Trial Site 840354
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Hialeah Gardens, Florida, 미국, 33066
- Chiesi Clinical Trial Site 840256
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Kissimmee, Florida, 미국, 34741
- Chiesi Clinical Trial Site 840200
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Lakeland, Florida, 미국, 33803
- Chiesi Clinical Trial Site 840232
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Leesburg, Florida, 미국, 34748
- Chiesi Clinical Trial Site 840113
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Miami, Florida, 미국, 33122
- Chiesi Clinical Trial Site 840372
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Miami, Florida, 미국, 33125
- Chiesi Clinical Trial Site 840137
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Miami, Florida, 미국, 33125
- Chiesi Clinical Trial Site 840289
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Miami, Florida, 미국, 33125
- Chiesi Clinical Trial Site 840377
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Miami, Florida, 미국, 33125
- Chiesi Clinical Trial Site 840387
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Miami, Florida, 미국, 33126
- Chiesi Clinical Trial Site 840326
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Miami, Florida, 미국, 33133
- Chiesi Clinical Trial Site 840175
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Miami, Florida, 미국, 33133
- Chiesi Clinical Trial Site 840346
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Miami, Florida, 미국, 33134
- Chiesi Clinical Trial Site 840347
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Miami, Florida, 미국, 33135
- Chiesi Clinical Trial Site 840205
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Miami, Florida, 미국, 33135
- Chiesi Clinical Trial Site 840247
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Miami, Florida, 미국, 33135
- Chiesi Clinical Trial Site 840341
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Miami, Florida, 미국, 33144
- Chiesi Clinical Trial Site 840148
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Miami, Florida, 미국, 33144
- Chiesi Clinical Trial Site 840239
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Miami, Florida, 미국, 33144
- Chiesi Clinical Trial Site 840312
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Miami, Florida, 미국, 33144
- Chiesi Clinical Trial Site 840355
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Miami, Florida, 미국, 33144
- Chiesi Clinical Trial Site 840388
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Miami, Florida, 미국, 33155
- Chiesi Clinical Trial Site 840237
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Miami, Florida, 미국, 33155
- Chiesi Clinical Trial Site 840261
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Miami, Florida, 미국, 33155
- Chiesi Clinical Trial Site 840262
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Miami, Florida, 미국, 33155
- Chiesi Clinical Trial Site 840280
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Miami, Florida, 미국, 33165
- Chiesi Clinical Trial Site 840178
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Miami, Florida, 미국, 33165
- Chiesi Clinical Trial Site 840292
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Miami, Florida, 미국, 33166
- Chiesi Clinical Trial Site 840202
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Miami, Florida, 미국, 33169
- Chiesi Clinical Trial Site 840275
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Miami, Florida, 미국, 33173
- Chiesi Clinical Trial Site 840122
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Miami, Florida, 미국, 33173
- Chiesi Clinical Trial Site 840352
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Miami, Florida, 미국, 33174
- Chiesi Clinical Trial Site 840235
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Miami, Florida, 미국, 33174
- Chiesi Clinical Trial Site 840360
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Miami, Florida, 미국, 33174
- Chiesi Clinical Trial Site 840381
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Miami, Florida, 미국, 33175
- Chiesi Clinical Trial Site 840243
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Miami, Florida, 미국, 33175
- Chiesi Clinical Trial Site 840244
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Miami, Florida, 미국, 33175
- Chiesi Clinical Trial Site 840257
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Miami, Florida, 미국, 33175
- Chiesi Clinical Trial Site 840380
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Miami, Florida, 미국, 33175
- Chiesi Clinical Trial Site 840382
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Miami, Florida, 미국, 33176
- Chiesi Clinical Trial Site 840367
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Miami, Florida, 미국, 33186
- Chiesi Clinical Trial Site 840162
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Miami, Florida, 미국, 33186
- Chiesi Clinical Trial Site 840166
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Miami, Florida, 미국, 33186
- Chiesi Clinical Trial Site 840370
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Miami, Florida, 미국, 33186
- Chiesi Clinical Trial Site 840392
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Miami Beach, Florida, 미국, 33141
- Chiesi Clinical Trial Site 840319
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Miami Lakes, Florida, 미국, 33014
- Chiesi Clinical Trial Site 840328
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Miami Lakes, Florida, 미국, 33014
- Chiesi Clinical Trial Site 840378
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Miami Lakes, Florida, 미국, 33016
- Chiesi Clinical Trial Site 840288
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Miami Lakes, Florida, 미국, 33016
- Chiesi Clinical Trial Site 840385
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Miami Lakes, Florida, 미국, 33144
- Chiesi Clinical Trial Site 840353
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Mt. Dora, Florida, 미국, 32757
- Chiesi Clinical Trial Site 840140
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New Port Richey, Florida, 미국, 34652
- Chiesi Clinical Trial Site 840263
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North Miami, Florida, 미국, 33161
- Chiesi Clinical Trial Site 840132
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North Miami Beach, Florida, 미국, 33160
- Chiesi Clinical Trial Site 840161
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Orlando, Florida, 미국, 32807
- Chiesi Clinical Trial Site 840255
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Orlando, Florida, 미국, 32822
- Chiesi Clinical Trial Site 840110
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Orlando, Florida, 미국, 32825
- Chiesi Clinical Trial Site 840125
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Palmetto Bay, Florida, 미국, 33157
- Chiesi Clinical Trial Site 840121
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Pembroke Pines, Florida, 미국, 33024
- Chiesi Clinical Trial Site 840196
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Pembroke Pines, Florida, 미국, 33024
- Chiesi Clinical Trial Site 840198
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Plantation, Florida, 미국, 33317
- Chiesi Clinical Trial Site 840363
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Plantation, Florida, 미국, 33317
- Chiesi Clinical Trial Site 840371
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Pompano Beach, Florida, 미국, 33064
- Chiesi Clinical Trial Site 840252
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Port Charlotte, Florida, 미국, 33952
- Chiesi Clinical Trial Site 840105
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Sarasota, Florida, 미국, 34239
- Chiesi Clinical Trial Site 840294
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St. Petersburg, Florida, 미국, 33704
- Chiesi Clinical Trial Site 840291
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Tampa, Florida, 미국, 33607
- Chiesi Clinical Trial Site 840313
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Tampa, Florida, 미국, 33607
- Chiesi Clinical Trial Site 840356
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Tampa, Florida, 미국, 33607
- Chiesi Clinical Trial Site 840379
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Tampa, Florida, 미국, 33613
- Chiesi Clinical Trial Site 840131
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Tampa, Florida, 미국, 33614
- Chiesi Clinical Trial Site 840324
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Tampa, Florida, 미국, 33634
- Chiesi Clinical Trial Site 840309
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The Villages, Florida, 미국, 32162
- Chiesi Clinical Trial Site 840210
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Winter Park, Florida, 미국, 32789
- Chiesi Clinical Trial Site 840129
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Georgia
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Adairsville, Georgia, 미국, 30103
- Chiesi Clinical Trial Site 840223
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Columbus, Georgia, 미국, 31904
- Chiesi Clinical Trial Site 840218
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Columbus, Georgia, 미국, 31904
- Chiesi Clinical Trial Site 840414
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Cordele, Georgia, 미국, 31015
- Chiesi Clinical Trial Site 840437
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Lawrenceville, Georgia, 미국, 30044
- Chiesi Clinical Trial Site 840390
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Lawrenceville, Georgia, 미국, 30046
- Chiesi Clinical Trial Site 840227
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Rincon, Georgia, 미국, 31326
- Chiesi Clinical Trial Site 840138
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Stonecrest, Georgia, 미국, 30038
- Chiesi Clinical Trial Site 840417
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Union City, Georgia, 미국, 30291
- Chiesi Clinical Trial Site 840383
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Illinois
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Chicago, Illinois, 미국, 60602
- Chiesi Clinical Trial Site 840321
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Chicago Ridge, Illinois, 미국, 60415
- Chiesi Clinical Trial Site 840365
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Indiana
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Hammond, Indiana, 미국, 46324
- Chiesi Clinical Trial Site 840407
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Valparaiso, Indiana, 미국, 76383
- Chiesi Clinical Trial Site 840108
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Iowa
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Council Bluffs, Iowa, 미국, 51503
- Chiesi Clinical Trial Site 840318
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Louisiana
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Crowley, Louisiana, 미국, 70526
- Chiesi Clinical Trial Site 840207
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Zachary, Louisiana, 미국, 70791
- Chiesi Clinical Trial Site 840436
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Maine
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Bangor, Maine, 미국, 04401
- Chiesi Clinical Trial Site 840451
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Maryland
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Baltimore, Maryland, 미국, 21237
- Chiesi Clinical Trial Site 840447
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Baltimore, Maryland, 미국, 21287
- Chiesi Clinical Trial Site 840376
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Westminster, Maryland, 미국, 21157
- Chiesi Clinical Trial Site 840199
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Massachusetts
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Fall River, Massachusetts, 미국, 02723
- Chiesi Clinical Trial Site 840214
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New Bedford, Massachusetts, 미국, 02740
- Chiesi Clinical Trial Site 840322
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North Dartmouth, Massachusetts, 미국, 02747
- Chiesi Clinical Trial site 840250
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Michigan
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Dearborn, Michigan, 미국, 48124
- Chiesi Clinical Trial Site 840325
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Dearborn, Michigan, 미국, 48126
- Chiesi Clinical Trial Site 840400
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Farmington Hills, Michigan, 미국, 48336
- Chiesi Clinical Trial Site 840183
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Flint, Michigan, 미국, 48504
- Chiesi Clinical Trial Site 840340
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Flint, Michigan, 미국, 48532
- Chiesi Clinical Trial Site 840401
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Novi, Michigan, 미국, 48375
- Chiesi Clinical Trial Site 840345
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Southfield, Michigan, 미국, 48034
- Chiesi Clinical Trial Site 840287
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Southfield, Michigan, 미국, 48075
- Chiesi Clinical Trial Site 840415
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Mississippi
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Fayette, Mississippi, 미국, 39069
- Chiesi Clinical Trial Site 840444
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Ridgeland, Mississippi, 미국, 39157
- Chiesi Clinical Trial Site 840448
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Missouri
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Chesterfield, Missouri, 미국, 63017
- Chiesi Clinical Trial Site 840278
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Columbia, Missouri, 미국, 65203
- Chiesi Clinical Trial Site 840155
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Richmond Heights, Missouri, 미국, 63117
- Chiesi Clinical Trial Site 840316
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Saint Charles, Missouri, 미국, 63301
- Chiesi Clinical Trial Site 840150
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St Louis, Missouri, 미국, 63123
- Chiesi Clinical Trial Site 840282
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St Louis, Missouri, 미국, 63141
- Chiesi Clinical Trial Site 840123
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St Louis, Missouri, 미국, 63141
- Chiesi Clinical Trial Site 840142
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Montana
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Missoula, Montana, 미국, 59808
- Chiesi Clinical Trial Site 840273
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Nebraska
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Lincoln, Nebraska, 미국, 68506
- Chiesi Clinical Trial Site 840281
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Omaha, Nebraska, 미국, 68114
- Chiesi Clinical Trial Site 840329
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Nevada
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Las Vegas, Nevada, 미국, 840213
- Chiesi Clinical Trial Site 840213
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Las Vegas, Nevada, 미국, 89106
- Chiesi Clinical Trial Site 840285
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Las Vegas, Nevada, 미국, 89123
- Chiesi Clinical Trial Site 840299
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New Hampshire
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Portsmouth, New Hampshire, 미국, 03810
- Chiesi Clinical Trial Site 840338
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New Jersey
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Berlin, New Jersey, 미국, 08009
- Chiesi Clinical Trial Site 840297
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Toms River, New Jersey, 미국, 08755
- Chiesi Clinical Trial Site 840333
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New York
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Binghamton, New York, 미국, 13905
- Chiesi Clinical Trial Site 840330
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Brooklyn, New York, 미국, 11235
- Chiesi Clinical Trial Site 840397
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Buffalo, New York, 미국, 14201
- Chiesi Clinical Trial Site 840254
-
Buffalo, New York, 미국, 14203
- Chiesi Clinical Trial Site 840307
-
Flushing, New York, 미국, 11355
- Chiesi Clinical Trial Site 840368
-
New Windsor, New York, 미국, 12553
- Chiesi Clinical Trial Site 840362
-
The Bronx, New York, 미국, 10455
- Chiesi Clinical Trial Site 840128
-
-
North Carolina
-
Charlotte, North Carolina, 미국, 28207
- Chiesi Clinical Trial Site 840215
-
Charlotte, North Carolina, 미국, 28210
- Chiesi Clinical Trial Site 840366
-
Charlotte, North Carolina, 미국, 28277
- Chiesi Clinical Trial Site 840158
-
Denver, North Carolina, 미국, 28037
- Chiesi Clinical Trial Site 840409
-
Durham, North Carolina, 미국, 27705
- Chiesi Clinical Trial Site 840403
-
Gastonia, North Carolina, 미국, 28054
- Chiesi Clinical Trial Site 840428
-
Huntersville, North Carolina, 미국, 28078
- Chiesi Clinical Trial Site 840236
-
Monroe, North Carolina, 미국, 28112
- Chiesi Clinical Trial Site 840259
-
Morgantown, North Carolina, 미국, 28655
- Chiesi Clinical Trial Site 840440
-
New Bern, North Carolina, 미국, 28562
- Chiesi Clinical Trial Site 840194
-
Raleigh, North Carolina, 미국, 27607
- Chiesi Clinical Trial Site 840120
-
Raleigh, North Carolina, 미국, 27607
- Chiesi Clinical Trial Site 840438
-
Raleigh, North Carolina, 미국, 27617
- Chiesi Clinical Trial Site 840429
-
Rocky Mount, North Carolina, 미국, 27804
- Chiesi Clinical Trial Site 840112
-
Shelby, North Carolina, 미국, 28150
- Chiesi Clinical Trial Site 840135
-
Wilmington, North Carolina, 미국, 28403
- Chiesi Clinical Trial Site 840189
-
Winston-Salem, North Carolina, 미국, 27103
- Chiesi Clinical Trial Site 840412
-
-
Ohio
-
Akron, Ohio, 미국, 44313
- Chiesi Clinical Trial Site 840445
-
Cincinnati, Ohio, 미국, 45231
- Chiesi Clinical Trial Site 840104
-
Cincinnati, Ohio, 미국, 45242
- Chiesi Clinical Trial Site 840357
-
Columbus, Ohio, 미국, 43215
- Chiesi Clinical Trial Site 840124
-
Dayton, Ohio, 미국, 45424
- Chiesi Clinical Trial Site 840426
-
Kettering, Ohio, 미국, 45439
- Chiesi Clinical Trial Site 840302
-
Maumee, Ohio, 미국, 43537
- Chiesi Clinical Trial Site 840233
-
Middleburg Heights, Ohio, 미국, 44130
- Chiesi Clinical Trial Site 840167
-
Toledo, Ohio, 미국, 43617
- Chiesi Clinical Trial Site 840157
-
-
Oregon
-
Medford, Oregon, 미국, 97504
- Chiesi Clinical Trial Site 840203
-
-
Pennsylvania
-
Beaver, Pennsylvania, 미국, 15009
- Chiesi Clinical Trial Site 840300
-
DuBois, Pennsylvania, 미국, 15801
- Chiesi Clinical Trial Site 840308
-
Jenkintown, Pennsylvania, 미국, 19046
- Chiesi Clinical Trial Site 840156
-
Pittsburgh, Pennsylvania, 미국, 15236
- Chiesi Clinical Trial Site 840327
-
Scotland, Pennsylvania, 미국, 15683
- Chiesi Clinical Trial Site 840418
-
Smithfield, Pennsylvania, 미국, 15478
- Chiesi Clinical Trial Site 840419
-
-
Rhode Island
-
Cranston, Rhode Island, 미국, 02920
- Chiesi Clinical Trial Site 840450
-
Cumberland, Rhode Island, 미국, 02864
- Chiesi Clinical Trial Site 840332
-
-
South Carolina
-
Anderson, South Carolina, 미국, 29621
- Chiesi Clinical Trial Site 840222
-
Anderson, South Carolina, 미국, 29621
- Chiesi Clinical Trial Site 840435
-
Charleston, South Carolina, 미국, 29406
- Chiesi Clinical Trial Site 840431
-
Columbia, South Carolina, 미국, 29201
- Chiesi Clinical Trial Site 840334
-
Columbia, South Carolina, 미국, 29204
- Chiesi Clinical Trial Site 840130
-
Columbia, South Carolina, 미국, 29223
- Chiesi Clinical Trial Site 840430
-
Fort Mill, South Carolina, 미국, 29707
- Chiesi Clinical Trial Site 840211
-
Gaffney, South Carolina, 미국, 29340
- Chiesi Clinical Trial Site 840182
-
Greenville, South Carolina, 미국, 29615
- Chiesi Clinical Trial Site 840111
-
Lancaster, South Carolina, 미국, 29720
- Chiesi Clinical Trial Site 840420
-
Mauldin, South Carolina, 미국, 29662
- Chiesi Clinical Trial Site 840386
-
Rock Hill, South Carolina, 미국, 29732
- Chiesi Clinical Trial Site 840100
-
Spartanburg, South Carolina, 미국, 29303
- Chiesi Clinical Trial Site 840375
-
Union, South Carolina, 미국, 29379
- Chiesi Clinical Trial Site 840106
-
West Columbia, South Carolina, 미국, 29169
- Chiesi Clinical Trial Site 840295
-
-
South Dakota
-
Rapid City, South Dakota, 미국, 57702
- Chiesi Clinical Trial Site 840398
-
-
Tennessee
-
Chattanooga, Tennessee, 미국, 37404
- Chiesi Clinical Trial Site 840305
-
Franklin, Tennessee, 미국, 37067
- Chiesi Clinical Trial Site 840351
-
Johnson City, Tennessee, 미국, 37601
- Chiesi Clinical Trial Site 840306
-
Knoxville, Tennessee, 미국, 37909
- Chiesi Clinical Trial Site 840171
-
Nashville, Tennessee, 미국, 37203
- Chiesi Clinical Trial Site 840361
-
Tullahoma, Tennessee, 미국, 37388
- Chiesi Clinical Trial Site 840271
-
-
Texas
-
Baytown, Texas, 미국, 77521
- Chiesi Clinical Trial Site 840101
-
Boerne, Texas, 미국, 78006
- Chiesi Clinical Trial Site 840114
-
Cypress, Texas, 미국, 77429
- Chiesi Clinical Trial Site 840146
-
Dallas, Texas, 미국, 75230
- Chiesi Clinical Trial Site 840413
-
Houston, Texas, 미국, 77008
- Chiesi Clinical Trial Site 840284
-
Houston, Texas, 미국, 77008
- Chiesi Clinical Trial Site 840411
-
Houston, Texas, 미국, 77030
- Chiesi Clinical Trial Site 840389
-
Houston, Texas, 미국, 77084
- Chiesi Clinical Trial Site 840185
-
Houston, Texas, 미국, 77098
- Chiesi Clinical Trial Site 840224
-
Humble, Texas, 미국, 77396
- Chiesi Clinical Trial Site 840408
-
Katy, Texas, 미국, 77494
- Chiesi Clinical Trial Site 840102
-
Katy, Texas, 미국, 77494
- Chiesi Clinical Trial Site 840274
-
Kerrville, Texas, 미국, 78028
- Chiesi Clinical Trial Site 840432
-
Lampasas, Texas, 미국, 76550
- Chiesi Clinical Trial Site 840160
-
McAllen, Texas, 미국, 78503
- Chiesi Clinical Trial Site 840424
-
McKinney, Texas, 미국, 75069
- Chiesi Clinical Trial Site 840119
-
Nederland, Texas, 미국, 77627
- Chiesi Clinical Trial Site 840442
-
North Richland Hills, Texas, 미국, 76180
- Chiesi Clinical Trial Site 840176
-
Pearland, Texas, 미국, 77584
- Chiesi Clinical Trial Site 840283
-
San Antonio, Texas, 미국, 78063
- Chiesi Clinical Trial Site 840191
-
San Antonio, Texas, 미국, 78215
- Chiesi Clinical Trial Site 840320
-
San Antonio, Texas, 미국, 78229
- Chiesi Clinical Trial Site 840410
-
Sherman, Texas, 미국, 75092
- Chiesi Clinical Trial Site 840231
-
Sherman, Texas, 미국, 75092
- Chiesi Clinical Trial Site 840396
-
Splendora, Texas, 미국, 77372
- Chiesi Clinical Trial Site 840394
-
Sugar Land, Texas, 미국, 77479
- Chiesi Clinical Trial Site 840221
-
Tomball, Texas, 미국, 77375
- Chiesi Clinical Trial Site 840139
-
Tomball, Texas, 미국, 77375
- Chiesi Clinical Trial Site 840314
-
-
Vermont
-
Colchester, Vermont, 미국, 05446
- Chiesi Clinical Trial Site 840337
-
-
Virginia
-
Manassas, Virginia, 미국, 20110
- Chiesi Clinical Trial Site 840264
-
Richmond, Virginia, 미국, 23219
- Chiesi Clinical Trial Site 840159
-
Richmond, Virginia, 미국, 23226
- Chiesi Clinical Trial Site 840425
-
-
Washington
-
Everett, Washington, 미국, 98208
- Chiesi Clinical Trial Site 840423
-
Renton, Washington, 미국, 98055
- Chiesi Clinical Trial Site 840342
-
Vancouver, Washington, 미국, 98664
- Chiesi Clinical Trial Site 840154
-
-
West Virginia
-
Kingwood, West Virginia, 미국, 26537
- Chiesi Clinical Trial Site 840421
-
Morgantown, West Virginia, 미국, 26505
- Chiesi Clinical Trial Site 840201
-
-
-
-
-
Gabrovo, 불가리아
- Chiesi Clinical Trial Site 100125
-
Haskovo, 불가리아
- Chiesi Clinical Trial Site 100109
-
Kozloduy, 불가리아, 3320
- Chiesi Clinical Trial Site 100129
-
Lovech, 불가리아
- Chiesi Clinical Trial Site 100111
-
Montana, 불가리아
- Chiesi Clinical Trial Site 100115
-
Pleven, 불가리아, 5808
- Chiesi Clinical Trial Site 100132
-
Pleven, 불가리아
- Chiesi Clinical Trial Site 100101
-
Plovdiv, 불가리아, 4003
- Chiesi Clinical Trial Site 100131
-
Plovdiv, 불가리아
- Chiesi Clinical Trial Site 100102
-
Plovdiv, 불가리아
- Chiesi Clinical Trial Site 100126
-
Razgrad, 불가리아, 7200
- Chiesi Clinical Trial Site 100128
-
Rousse, 불가리아
- Chiesi Clinical Trial Site 100104
-
Rousse, 불가리아
- Chiesi Clinical Trial Site 100113
-
Sofia, 불가리아
- Chiesi Clinical Trial Site 100100
-
Sofia, 불가리아
- Chiesi Clinical Trial Site 100110
-
Sofia, 불가리아
- Chiesi Clinical Trial Site 100112
-
Sofia, 불가리아
- Chiesi Clinical Trial Site 100116
-
Sofia, 불가리아
- Chiesi Clinical Trial Site 100117
-
Sofia, 불가리아
- Chiesi Clinical Trial Site 100118
-
Sofia, 불가리아
- Chiesi Clinical Trial Site 100119
-
Sofia, 불가리아
- Chiesi Clinical Trial Site 100121
-
Sofia, 불가리아
- Chiesi Clinical Trial Site 100123
-
Sofia, 불가리아
- Chiesi Clinical Trial Site 100124
-
Sofia, 불가리아
- Chiesi Clinical Trial Site 100127
-
Stara Zagora, 불가리아
- Chiesi Clinical Trial Site 100103
-
Stara Zagora, 불가리아
- Chiesi Clinical Trial Site 100107
-
Varna, 불가리아, 9020
- Chiesi Clinical Trial Site 100130
-
Veliko Tarnovo, 불가리아
- Chiesi Clinical Trial Site 100122
-
Vidin, 불가리아
- Chiesi Clinical Trial Site 100106
-
Vidin, 불가리아
- Chiesi Clinical Trial Site 100114
-
-
-
-
-
Buenos Aires, 아르헨티나, 1407
- Chiesi Clinical Trial Site 032125
-
Buenos Aires, 아르헨티나, C1425FVH
- Chiesi Clinical Trial Site 032130
-
Buenos Aires, 아르헨티나
- Chiesi Clinical Trial Site 032133
-
Ciudad Autonoma de Buenos Aire, 아르헨티나, 1430
- Chiesi Clinical Trial Site 032103
-
Ciudad Autonoma de Buenos Aire, 아르헨티나, B1602DOH
- Chiesi Clinical Trial Site 032109
-
Córdoba, 아르헨티나, 5000
- Chiesi Clinical Trial Site 032122
-
Lobos, 아르헨티나, 7240
- Chiesi Clinical Trial Site 032131
-
Mar del Plata, 아르헨티나, 7600
- Chiesi Clinical Trial Site 032119
-
Mendoza, 아르헨티나, 5500
- Chiesi Clinical Trial Site 032105
-
Mendoza, 아르헨티나, 5500
- Chiesi Clinical Trial Site 032129
-
Mendoza, 아르헨티나, M5502IDE
- Chiesi Clinical Trial Site 032126
-
Paraná, 아르헨티나, 3100
- Chiesi Clinical Trial Site 032123
-
Rosario, 아르헨티나, S2002OJN
- Chiesi Clinical Trial Site 032128
-
San Miguel de Tucumán, 아르헨티나, 4000
- Chiesi Clinical Trial Site 032134
-
San Miguel de Tucumán, 아르헨티나, 4000
- Chiesi Clinical Trial Site 032136
-
San Rafael, 아르헨티나, 5600
- Chiesi Clinical Trial Site 032127
-
Santa Fe, 아르헨티나, 3000
- Chiesi Clinical Trial Site 032124
-
-
Buenos Aires
-
Ciudad Autonoma de Buenos Aire, Buenos Aires, 아르헨티나, 1056ABJ
- Chiesi Clinical Trial Site 032115
-
Ciudad Autonoma de Buenos Aire, Buenos Aires, 아르헨티나, 1426
- Chiesi Clinical Trial Site 032113
-
Ciudad Autonoma de Buenos Aire, Buenos Aires, 아르헨티나, B1837
- Chiesi Clinical Trial Site 032107
-
Ciudad Autonoma de Buenos Aire, Buenos Aires, 아르헨티나, C1426ABO
- Chiesi Clinical Trial Site 032112
-
Ciudad Autonoma de Buenos Aire, Buenos Aires, 아르헨티나, Cl425DTG
- Chiesi Clinical Trial Site 032121
-
La Plata, Buenos Aires, 아르헨티나, 1900
- Chiesi Clinical Trial Site 032108
-
Mar del Plata, Buenos Aires, 아르헨티나, 3168
- Chiesi Clinical Trial Site 032118
-
Mar del Plata, Buenos Aires, 아르헨티나, B7600FZO
- Chiesi Clinical Trial Site 032114
-
Monte Grande, Buenos Aires, 아르헨티나, 1842
- Chiesi Clinical Trial Site 032102
-
Quilmes, Buenos Aires, 아르헨티나, B1878FNR
- Chiesi Clinical Trial Site 032106
-
San Fernando, Buenos Aires, 아르헨티나, 1646
- Chiesi Clinical Trial Site 032116
-
San Juan Bautista, Buenos Aires, 아르헨티나, B1853AIK
- Chiesi Clinical Trial Site 032110
-
Vicente López, Buenos Aires, 아르헨티나, 1602
- Chiesi Clinical Trial Site 032100
-
-
Córdoba Province
-
Córdoba, Córdoba Province, 아르헨티나, X5008HHW
- Chiesi Clinical Trial Site 032111
-
-
Entre Ríos Province
-
Concepción del Uruguay, Entre Ríos Province, 아르헨티나, E3260EPD
- Chiesi Clinical Trial Site 032120
-
-
Santa Fe Province
-
Rosario, Santa Fe Province, 아르헨티나, 2000
- Chiesi Clinical Trial Site 032101
-
Rosario, Santa Fe Province, 아르헨티나, S2121
- Chiesi Clinical Trial Site 032132
-
-
Tucumán Province
-
San Miguel de Tucumán, Tucumán Province, 아르헨티나, T4000
- Chiesi Clinical Trial Site 032117
-
-
-
-
-
Brandýs nad Labem, 체코
- Chiesi Clinical Trial Site 203101
-
Jindřichův Hradec, 체코
- Chiesi Clinical Trial Site 203107
-
Miroslav, 체코
- Chiesi Clinical Trial Site 203109
-
Prague, 체코, 11000
- Chiesi Clinical Trial Site 203116
-
Prague, 체코, 140 00
- Chiesi Clinical Trial Site 203115
-
Prague, 체코
- Chiesi Clinical Trial Site 203114
-
Rokycany, 체코
- Chiesi Clinical Trial Site 203112
-
Strakonice, 체코
- Chiesi Clinical Trial Site 203108
-
Teplice, 체코
- Chiesi Clinical Trial Site 203104
-
Tábor, 체코
- Chiesi Clinical Trial Site 203105
-
Varnsdorf, 체코
- Chiesi Clinical Trial Site 203110
-
-
-
-
Alberta
-
Edmonton, Alberta, 캐나다, T5A 4L8
- Chiesi Clinical Trial Site 124103
-
Sherwood Park, Alberta, 캐나다, T8H 0N2
- Chiesi Clinical Trial Site 124105
-
-
Ontario
-
Burlington, Ontario, 캐나다, L7N 3V2
- Chiesi Clinical Trial Site 124102
-
Greater Sudbury, Ontario, 캐나다, P3C 1X3
- Chiesi Clinical Trial Site 124104
-
Windsor, Ontario, 캐나다, N8X 1T3
- Chiesi Clinical Trial Site 124100
-
-
Quebec
-
Trois-Rivières, Quebec, 캐나다, G8T 7A1
- Chiesi Clinical Trial Site 124106
-
-
-
-
-
Bialystok, 폴란드, 15-003
- Chiesi Clinical Trial Site 616125
-
Bialystok, 폴란드
- Chiesi Clinical Trial Site 616119
-
Giżycko, 폴란드
- Chiesi Clinical Trial Site 616100
-
Grudziądz, 폴란드
- Chiesi Clinical Trial Site 616113
-
Katowice, 폴란드
- Chiesi Clinical Trial Site 616116
-
Krakow, 폴란드, 30-149
- Chiesi Clinical Trial Site 616122
-
Krakow, 폴란드
- Chiesi Clinical Trial Site 616106
-
Krakow, 폴란드
- Chiesi Clinical Trial Site 616109
-
Krakow, 폴란드
- Chiesi Clinical Trial Site 616118
-
Lodz, 폴란드
- Chiesi Clinical Trial Site 616103
-
Olsztyn, 폴란드
- Chiesi Clinical Trial Site 616128
-
Ostrowiec, 폴란드
- Chiesi Clinical Trial Site 616117
-
Ostróda, 폴란드
- Chiesi Clinical Trial Site 616105
-
Poznan, 폴란드, 60-214
- Chiesi Clinical Trial Site 616123
-
Poznan, 폴란드
- Chiesi Clinical Trial Site 616107
-
Poznan, 폴란드
- Chiesi Clinical Trial Site 616110
-
Rzeszów, 폴란드
- Chiesi Clinical Trial Site 616108
-
Skierniewice, 폴란드
- Chiesi Clinical Trial Site 616114
-
Skorzewo, 폴란드, 60-185
- Chiesi Clinical Trial Site 616120
-
Sosnowiec, 폴란드
- Chiesi Clinical Trial Site 616102
-
Tarnów, 폴란드
- Chiesi Clinical Trial Site 616111
-
Torun, 폴란드
- Chiesi Clinical Trial Site 616115
-
Warsaw, 폴란드, 00-215
- Chiesi Clinical Trial Site 616127
-
Wroclaw, 폴란드, 54-239
- Chiesi Clinical Trial Site 616126
-
Wroclaw, 폴란드
- Chiesi Clinical Trial Site 616104
-
Wroclaw, 폴란드
- Chiesi Clinical Trial Site 616112
-
Zawadzkie, 폴란드
- Chiesi Clinical Trial Site 616101
-
-
-
-
-
Guaynabo, 푸에르토 리코, 00968
- Chiesi Clinical Trial Site 840393
-
-
-
-
-
Debrecen, 헝가리
- Chiesi Clinical Trial Site 348118
-
Hajdúnánás, 헝가리
- Chiesi Clinical Trial Site 348112
-
Hatvan, 헝가리
- Chiesi Clinical Trial Site 348116
-
Monor, 헝가리
- Chiesi Clinical Trial Site 348103
-
Sellye, 헝가리, 7960
- Chiesi Clinical Trial Site 348125
-
-
BA
-
Komló, BA, 헝가리, 7300
- Chiesi Clinical Trial Site 348121
-
Pécs, BA, 헝가리, 7626
- Chiesi Clinical Trial Site 348122
-
-
GS
-
Csorna, GS, 헝가리, 9300
- Chiesi Clinical Trial Site 348124
-
-
JN
-
Szolnok, JN, 헝가리, 5000
- Chiesi Clinical Trial Site 348126
-
-
Nógrád megye
-
Balassagyarmat, Nógrád megye, 헝가리
- Chiesi Clinical Trial Site 348107
-
-
Pest County
-
Gödöllő, Pest County, 헝가리
- Chiesi Clinical Trial Site 348120
-
-
Szabolcs-Szatmár-Bereg
-
Nyíregyháza, Szabolcs-Szatmár-Bereg, 헝가리
- Chiesi Clinical Trial Site 348104
-
Nyíregyháza, Szabolcs-Szatmár-Bereg, 헝가리
- Chiesi Clinical Trial Site 348109
-
-
Vas County
-
Szombathely, Vas County, 헝가리
- Chiesi Clinical Trial Site 348105
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
40년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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:
- 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).
- 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
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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
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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:
- Systemic/oral/parenteral corticosteroids in the prior 4 weeks
- Use of antibiotics for a lower respiratory tract infection (e.g. pneumonia) or COPD exacerbation in the prior 4 weeks
- Any long-term chronic maintenance use of antibiotic treatment in the prior 4 weeks
- 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
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Current treatment with non-cardioselective β-blockers
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Requirement of long term (> 15 hours daily) oxygen therapy
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Known respiratory disorders other than COPD which may impact the efficacy of the study drug according to investigator's judgement.
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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)
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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
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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
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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:
- Atrial fibrillation (AF) with rapid ventricular response > 120 bpm
- Ventricular tachycardias (sustained, non-sustained [>3 up to 30 sec])
- Evidence of Mobitz Type II second degree or third-degree atrioventricular block
- Prolonged QTcF (>450ms for males, or >470ms for females). This criterion is not applicable for subjects with a pacemaker or permanent AF.
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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
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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
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Malignancy that has not been in complete remission for at least 1 year or any untreated localized carcinomas
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History of alcohol abuse and/or substance/drug abuse within 12 months prior to the screening visit
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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
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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
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Mentally or legally incapacitated, or subjects incarcerated as a result of an official or judicial order
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Major surgery in the 3 months prior to the screening visit or have a planned surgery during the trial
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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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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 |
Available in pressurized inhalation solution BDP/FF/GB 100/6/12.5μg and BDP/FF 100/6μg
다른 이름들:
Available in pressurized inhalation solution BDP/FF/GB 100/6/12.5μg
다른 이름들:
Available in pressurized inhalation solution BDP/FF/GB 100/6/12.5μg and BDP/FF 100/6μg
다른 이름들:
|
|
활성 비교기: BDP/FF - CHF 1535
Two inhalations twice daily of BDP/FF (100/6μg) for a period of 52 weeks via pressurized metered dose inhaler |
Available in pressurized inhalation solution BDP/FF/GB 100/6/12.5μg and BDP/FF 100/6μg
다른 이름들:
Available in pressurized inhalation solution BDP/FF/GB 100/6/12.5μg and BDP/FF 100/6μg
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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28주차에 투여 전 아침 1초 강제 호기량(FEV1)의 기준선으로부터의 변화
기간: 28주차
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28주차
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
28주차에 투여 후 2시간 아침 FEV1의 기준선으로부터의 변화
기간: 28주차
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28주차
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지정된 진료소 방문 시 투여 전 아침 FEV1의 기준선으로부터의 변화
기간: 4주차, 10주차, 40주차, 52주차
|
4주차, 10주차, 40주차, 52주차
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투여 후 2시간 아침 FEV1 지정 진료소 방문에서 기준선으로부터의 변화
기간: 1일차, 4주차, 10주차, 40주차, 52주차
|
1일차, 4주차, 10주차, 40주차, 52주차
|
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지정된 진료소 방문 시 FEV1 투여 전에서 투여 후 2시간 아침으로 변경
기간: 1일차, 4주차, 10주차, 28주차, 40주차, 52주차
|
1일차, 4주차, 10주차, 28주차, 40주차, 52주차
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지정 진료소 방문 시 FEV1 반응(투약 전 아침 FEV1 ≥100ml의 기준선에서 변화)
기간: 1일차, 4주차, 10주차, 28주차, 40주차, 52주차
|
1일차, 4주차, 10주차, 28주차, 40주차, 52주차
|
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최초 중등도 또는 중증 COPD 악화까지의 시간
기간: 52주 치료기간
|
52주 치료기간
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첫 중증 COPD 악화까지의 시간
기간: 52주 치료기간
|
52주 치료기간
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지정된 진료소 방문 시 세인트 조지 호흡기 설문지(SGRQ) 반응(총 점수 ≥4의 기준선에서 감소)
기간: 4주차, 10주차, 28주차, 40주차, 52주차
|
4주차, 10주차, 28주차, 40주차, 52주차
|
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각 지정된 클리닉 방문 시 SGRQ 총 점수 및 영역 점수의 기준선으로부터의 변화
기간: 4주차, 10주차, 28주차, 40주차, 52주차
|
4주차, 10주차, 28주차, 40주차, 52주차
|
|
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지정된 진료소 방문 시 투약 전 아침 강제 폐활량(FVC)의 기준선으로부터의 변화
기간: 4주차, 10주차, 28주차, 40주차, 52주차
|
4주차, 10주차, 28주차, 40주차, 52주차
|
|
|
지정된 진료소 방문 시 투약 전에서 투약 후 2시간 아침 FVC로 변경
기간: 1일차, 4주차, 10주차, 28주차, 40주차, 52주차
|
1일차, 4주차, 10주차, 28주차, 40주차, 52주차
|
|
|
지정된 진료소 방문 시 CAT 반응(기준선 ≥2점에서 감소)
기간: 4주차, 10주차, 28주차, 40주차, 52주차
|
4주차, 10주차, 28주차, 40주차, 52주차
|
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52주간의 치료에 걸쳐 건강 관련 삶의 질이 기준선에서 변경되었습니다(총 SGRQ 점수 ≥4에서 기준선에서 감소).
기간: 52주 치료기간
|
52주 치료기간
|
|
|
Rate of moderate and severe COPD exacerbations over 52 weeks of treatment
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Thomas Siler, MD, Midwest Chest Consultants
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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- Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009 Sep;34(3):648-54. doi: 10.1183/09031936.00102509.
- Quanjer PH, Stanojevic S, Cole TJ, Baur X, Hall GL, Culver BH, Enright PL, Hankinson JL, Ip MS, Zheng J, Stocks J; ERS Global Lung Function Initiative. Multi-ethnic reference values for spirometry for the 3-95-yr age range: the global lung function 2012 equations. Eur Respir J. 2012 Dec;40(6):1324-43. doi: 10.1183/09031936.00080312. Epub 2012 Jun 27.
- Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442.
- Ferenci P, Lockwood A, Mullen K, Tarter R, Weissenborn K, Blei AT. Hepatic encephalopathy--definition, nomenclature, diagnosis, and quantification: final report of the working party at the 11th World Congresses of Gastroenterology, Vienna, 1998. Hepatology. 2002 Mar;35(3):716-21. doi: 10.1053/jhep.2002.31250.
- Bestall JC, Paul EA, Garrod R, Garnham R, Jones PW, Wedzicha JA. Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax. 1999 Jul;54(7):581-6. doi: 10.1136/thx.54.7.581.
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- Bajaj JS, Cordoba J, Mullen KD, Amodio P, Shawcross DL, Butterworth RF, Morgan MY; International Society for Hepatic Encephalopathy and Nitrogen Metabolism (ISHEN). Review article: the design of clinical trials in hepatic encephalopathy--an International Society for Hepatic Encephalopathy and Nitrogen Metabolism (ISHEN) consensus statement. Aliment Pharmacol Ther. 2011 Apr;33(7):739-47. doi: 10.1111/j.1365-2036.2011.04590.x. Epub 2011 Feb 9.
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유용한 링크
- <p>Global Initiative for Chronic Obstructive Lung Disease: Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (2020 Report)</p>
- <p>ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials</p>
- <p>COPD Assessment Test (CAT)</p>
- <p>Measuring shortness of breath (dyspnea) in COPD.</p>
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2022년 4월 27일
기본 완료 (실제)
2026년 1월 12일
연구 완료 (실제)
2026년 1월 12일
연구 등록 날짜
최초 제출
2020년 3월 23일
QC 기준을 충족하는 최초 제출
2020년 3월 23일
처음 게시됨 (실제)
2020년 3월 25일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 21일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 17일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CLI-05993AA3-06
- 2020-002389-16 (EudraCT 번호)
- 2023 (미국 NIH 보조금/계약)
- 2023-510172-31-00 (씨티스)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 공유 액세스 기준
Chiesi clinical data sharing scope, process and data access criteria is available on the Chiesi Group website.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .