A 52-week, Placebo-controlled Study to Evaluate the Efficacy and Safety of 2 Doses of CHF6001 DPI (Tanimilast), as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis (PILASTER) (PILASTER)

December 11, 2025 updated by: Chiesi Farmaceutici S.p.A.

A 52-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI add-on to Maintenance Triple Therapy in Subjects With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Bronchitis

The purpose of the study is to evaluate the efficacy and safety of two doses of CHF6001 (Tanimilast), as add-on to maintenance triple therapy in the target patient population.

Study Overview

Status

Terminated

Conditions

Chronic Obstructive Pulmonary Disease

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4710

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Albania
- - Durrës, Albania
    - Chiesi Clinical Trial - Site 8455
  - Durrës, Albania
    - Chiesi Clinical Trial - Site 8459
  - Elbasan, Albania
    - Chiesi Clinical Trial - Site 8457
  - Korçë, Albania
    - Chiesi Clinical Trial - Site 8460
  - Tirana, Albania
    - Chiesi Clinical Trial - Site 8451
  - Tirana, Albania
    - Chiesi Clinical Trial - Site 8452
  - Tirana, Albania
    - Chiesi Clinical Trial - Site 8453
  - Tirana, Albania
    - Chiesi Clinical Trial - Site 8454
  - Tirana, Albania
    - Chiesi Clinical Trial - Site 8456
  - Tirana, Albania
    - Chiesi Clinical Trial - Site 8458
Argentina
- - Buenos Aires, Argentina, 7540
    - Chiesi Clinical Trial - Site 32415
  - Buenos Aires, Argentina
    - Chiesi Clinical Trial - Site 32407
  - Buenos Aires, Argentina
    - Chiesi Clinical Trial - Site 32410
  - Buenos Aires, Argentina
    - Chiesi Clinical Trial - Site 32454
  - CABA, Argentina
    - Chiesi Clinical Trial - Site 32459
  - Caba, Argentina
    - Chiesi Clinical Trial - Site 32457
  - Ciudad Autonoma de Buenos Aire, Argentina
    - Chiesi Clinical Trial - Site 32414
  - Córdoba, Argentina
    - Chiesi Clinical Trial - Site 32403
  - Córdoba, Argentina
    - Chiesi Clinical Trial - Site 32409
  - Florida, Argentina
    - Chiesi Clinical Trial - Site 32401
  - Forestal Entre Ríos, Argentina, 89862-000
    - Centro de Medicina Respiratoria - Concepcion del Uruguay - site 32463
  - La Plata, Argentina
    - Chiesi Clinical Trial - Site 32455
  - Mar del Plata, Argentina
    - Chiesi Clinical Trial - Site 32458
  - Mar del Plata, Argentina
    - Chiesi Clinical Trial - Site 32462
  - Mendoza, Argentina
    - Chiesi Clinical Trial - Site 32405
  - Mendoza, Argentina
    - Chiesi Clinical Trial - Site 32411
  - Mendoza, Argentina
    - Chiesi Clinical Trial - Site 32413
  - Monte Grande, Argentina
    - Chiesi Clinical Trial - Site 32402
  - Quilmes, Argentina
    - Chiesi Clinical Trial - Site 32406
  - Rosario, Argentina
    - Chiesi Clinical Trial - Site 32453
  - San Fernando, Argentina
    - Chiesi Clinical Trial - Site 32460
  - San Juan Bautista, Argentina
    - Chiesi Clinical Trial - Site 32408
  - San Miguel de Tucumán, Argentina
    - Chiesi Clinical Trial - Site 32452
  - San Miguel de Tucumán, Argentina
    - Chiesi Clinical Trial - Site 32461
  - San Miguel de Tucumán, Argentina
    - Chiesi Clinical Trial - Site 32412
  - San Miguel de Tucumán, Argentina
    - Chiesi Clinical Trial - Site 32451
  - San Miguel de Tucumán, Argentina
    - Chiesi Clinical Trial - Site 32464
  - Santa Fe, Argentina
    - Chiesi Clinical Trial - Site 32456
Australia
- - Adelaide, Australia
    - Chiesi Clinical Trial - Site 36453
  - Box Hill, Australia
    - Chiesi Clinical Trial - Site 36454
  - Campbelltown, Australia
    - Chiesi Clinical Trial - Site 36455
  - Clayton, Australia
    - Chiesi Clinical Trial - Site 36456
  - South Brisbane, Australia
    - Chiesi Clinical Trial - Site 36451
  - Westmead, Australia
    - Chiesi Clinical Trial - Site 36452
Austria
- - Feldbach, Austria
    - Chiesi Clinical Trial - Site 40402
  - Grieskirchen, Austria
    - Chiesi Clinical Trial - Site 40404
  - Linz, Austria, 4020
    - Chiesi Clinical Trial - Site 40406
  - Linz, Austria
    - Chiesi Clinical Trial - Site 40401
  - Linz, Austria
    - Chiesi Clinical Trial - Site 40403
  - Wels, Austria, 4600
    - Chiesi Clinical Trial - Site 40405
Bosnia and Herzegovina
- - Banja Luka, Bosnia and Herzegovina
    - Chiesi Clinical Trial - Site 070401
  - Doboj, Bosnia and Herzegovina
    - Chiesi Clinical Trial - Site 070407
  - Mostar, Bosnia and Herzegovina
    - Chiesi Clinical Trial - Site 070460
  - Pale, Bosnia and Herzegovina
    - Chiesi Clinical Trial - Site 070404
  - Sarajevo, Bosnia and Herzegovina, 71000
    - OJ Dom zdravlja Novo Sarajevo "Omer Maslić" - Site 70408
  - Sarajevo, Bosnia and Herzegovina
    - Chiesi Clinical Trial - Site 070405
  - Sarajevo, Bosnia and Herzegovina
    - Chiesi Clinical Trial - Site 070406
  - Tešanj, Bosnia and Herzegovina
    - Chiesi Clinical Trial - Site 070403
  - Tuzla, Bosnia and Herzegovina
    - Chiesi Clinical Trial - Site 070402
  - Tuzla, Bosnia and Herzegovina
    - Chiesi Clinical Trial - Site 070463
Bulgaria
- - Blagoevgrad, Bulgaria
    - Chiesi Clinical Trial - Site 100435
  - Dimitrovgrad, Bulgaria
    - Chiesi Clinical Trial - Site 100434
  - Gabrovo, Bulgaria
    - Chiesi Clinical Trial - Site 100453
  - Haskovo, Bulgaria
    - Chiesi Clinical Trial - Site 100423
  - Kozloduy, Bulgaria
    - Chiesi Clinical Trial - Site 100433
  - Lovech, Bulgaria
    - Chiesi Clinical Trial - Site 100455
  - Montana, Bulgaria
    - Chiesi Clinical Trial - Site 100415
  - Pernik, Bulgaria
    - Chiesi Clinical Trial - Site 100432
  - Pleven, Bulgaria
    - Chiesi Clinical Trial - Site 100422
  - Plovdiv, Bulgaria
    - Chiesi Clinical Trial - Site 100452
  - Plovdiv, Bulgaria
    - Chiesi Clinical Trial - Site 100456
  - Razgrad, Bulgaria
    - Chiesi Clinical Trial - Site 100437
  - Rousse, Bulgaria
    - Chiesi Clinical Trial - Site 100412
  - Rousse, Bulgaria
    - Chiesi Clinical Trial - Site 100416
  - Sevlievo, Bulgaria
    - Chiesi Clinical Trial - Site 100436
  - Sliven, Bulgaria
    - Chiesi Clinical Trial - Site 100460
  - Sofia, Bulgaria
    - Chiesi Clinical Trial - Site 100409
  - Sofia, Bulgaria
    - Chiesi Clinical Trial - Site 100414
  - Sofia, Bulgaria
    - Chiesi Clinical Trial - Site 100417
  - Sofia, Bulgaria
    - Chiesi Clinical Trial - Site 100418
  - Sofia, Bulgaria
    - Chiesi Clinical Trial - Site 100420
  - Sofia, Bulgaria
    - Chiesi Clinical Trial - Site 100430
  - Sofia, Bulgaria
    - Chiesi Clinical Trial - Site 100431
  - Sofia, Bulgaria
    - Chiesi Clinical Trial - Site 100438
  - Stara Zagora, Bulgaria
    - Chiesi Clinical Trial - Site 100424
  - Stara Zagora, Bulgaria
    - Chiesi Clinical Trial - Site 100454
  - Veliko Tarnovo, Bulgaria
    - Chiesi Clinical Trial - Site 100462
  - Vidin, Bulgaria
    - Chiesi Clinical Trial - Site 100419
  - Vidin, Bulgaria
    - Chiesi Clinical Trial - Site 100457
Chile
- - Concepción, Chile
    - Chiesi Clinical Trial - Site 152406
  - Quillota, Chile
    - Chiesi Clinical Trial - Site 152407
  - Santiago, Chile
    - Chiesi Clinical Trial - Site 152403
  - Santiago, Chile
    - Chiesi Clinical Trial - Site 152404
  - Talca, Chile
    - Chiesi Clinical Trial - Site 152409
  - Valparaíso, Chile
    - Chiesi Clinical Trial - Site 152401
China
- - Baotou, China
    - Chiesi Clinical Trial - Site 156473
  - Baotou, China
    - Chiesi Clinical Trial - Site 156507
  - Beijing, China
    - Chiesi Clinical Trial - Site 156474
  - Beijing, China
    - Chiesi Clinical Trial - Site 156489
  - Beijing, China
    - Chiesi Clinical Trial - Site 156509
  - Changchun, China
    - Chiesi Clinical Trial - Site 156501
  - Changsha, China
    - Chiesi Clinical Trial - Site 156455
  - Changsha, China
    - Chiesi Clinical Trial - Site 156488
  - Chengdu, China
    - Chiesi Clinical Trial - Site 156451
  - Chengdu, China
    - Chiesi Clinical Trial - Site 156490
  - Chongqing, China
    - Chiesi Clinical Trial - Site 156463
  - Chongqing, China
    - Chiesi Clinical Trial - Site 156511
  - Guangzhou, China
    - Chiesi Clinical Trial - Site 156452
  - Guangzhou, China
    - Chiesi Clinical Trial - Site 156460
  - Guangzhou, China
    - Chiesi Clinical Trial - Site 156471
  - Guangzhou, China
    - Chiesi Clinical Trial - Site 156472
  - Guangzhou, China
    - Chiesi Clinical Trial - Site 156494
  - Guangzhou, China
    - Chiesi Clinical Trial - Site 156504
  - Haikou, China
    - Chiesi Clinical Trial - Site 156468
  - Hangzhou, China
    - Chiesi Clinical Trial - Site 156498
  - Harbin, China
    - Chiesi Clinical Trial - Site 156510
  - Hefei, China
    - Chiesi Clinical Trial - Site 156486
  - Hefei, China
    - Chiesi Clinical Trial - Site 156503
  - Hengyang, China
    - Chiesi Clinical Trial - Site 156483
  - Hohhot, China
    - Chiesi Clinical Trial - Site 156512
  - Huanghou, China
    - Chiesi Clinical Trial - Site 156495
  - Huizhou, China
    - Chiesi Clinical Trial - Site 156506
  - Jinan, China
    - Chiesi Clinical Trial - Site 156456
  - Jinhua, China
    - Chiesi Clinical Trial - Site 156485
  - Liaoyang, China
    - Chiesi Clinical Trial - Site 156454
  - Nanchang, China
    - Chiesi Clinical Trial - Site 156453
  - Nanchang, China
    - Chiesi Clinical Trial - Site 156467
  - Nanjing, China
    - Chiesi Clinical Trial - Site 156484
  - Nanjing, China
    - Chiesi Clinical Trial - Site 156496
  - Nanjing, China
    - Chiesi Clinical Trial - Site 156497
  - Pingxiang, China
    - Chiesi Clinical Trial - Site 156481
  - Qingyuan, China
    - Chiesi Clinical Trial - Site 156464
  - Shanghai, China
    - Chiesi Clinical Trial - Site 156458
  - Shanghai, China
    - Chiesi Clinical Trial - Site 156461
  - Shanghai, China
    - Chiesi Clinical Trial - Site 156475
  - Shanghai, China
    - Chiesi Clinical Trial - Site 156476
  - Shanghai, China
    - Chiesi Clinical Trial - Site 156477
  - Shanghai, China
    - Chiesi Clinical Trial - Site 156487
  - Suzhou, China
    - Chiesi Clinical Trial - Site 156457
  - Taiyuan, China
    - Chiesi Clinical Trial - Site 156499
  - Taizhou, China
    - Chiesi Clinical Trial - Site 156469
  - Tianjin, China
    - Chiesi Clinical Trial - Site 156465
  - Tianjin, China
    - Chiesi Clinical Trial - Site 156480
  - Wuhan, China
    - Chiesi Clinical Trial - Site 156491
  - Wuhan, China
    - Chiesi Clinical Trial - Site 156505
  - Wuxi, China
    - Chiesi Clinical Trial - Site 156492
  - Wuxi, China
    - Chiesi Clinical Trial - Site 156493
  - Xiangtan, China
    - Chiesi Clinical Trial - Site 156470
  - Xining, China
    - Chiesi Clinical Trial - Site 156482
  - Xinxiang, China
    - Chiesi Clinical Trial - Site 156478
  - Xuzhou, China
    - Chiesi Clinical Trial - Site 156466
  - Xuzhou, China
    - Chiesi Clinical Trial - Site 156479
  - Yanji, China
    - Chiesi Clinical Trial - Site 156508
  - Yiyang, China
    - Chiesi Clinical Trial - Site 156459
  - Zhanjiang, China
    - Chiesi Clinical Trial - Site 156462
Czechia
- - Brandýs nad Labem, Czechia
    - Chiesi Clinical Trial - Site 203406
  - Havlíčkův Brod, Czechia
    - Chiesi Clinical Trial - Site 203418
  - Jindřichův Hradec, Czechia
    - Chiesi Clinical Trial - Site 203401
  - Lovosice, Czechia
    - Chiesi Clinical Trial - Site 203410
  - Miroslav, Czechia
    - Chiesi Clinical Trial - Site 203404
  - Mladá Boleslav, Czechia
    - Chiesi Clinical Trial - Site 203416
  - Měšice, Czechia
    - Chiesi Clinical Trial - Site 203417
  - Olomouc, Czechia
    - Chiesi Clinical Trial - Site 203453
  - Prague, Czechia
    - Chiesi Clinical Trial - Site 203452
  - Prague, Czechia
    - Chiesi Clinical Trial - Site 203405
  - Prague, Czechia
    - Chiesi Clinical Trial - Site 203407
  - Prague, Czechia
    - Chiesi Clinical Trial - Site 203413
  - Prague, Czechia
    - Chiesi Clinical Trial - Site 203415
  - Strakonice, Czechia
    - Chiesi Clinical Trial - Site 203402
  - Tábor, Czechia
    - Chiesi Clinical Trial - Site 203451
  - Varnsdorf, Czechia
    - Chiesi Clinical Trial - Site 203412
Georgia
- - Tbilisi, Georgia
    - Chiesi Clinical Trial - Site 268451
  - Tbilisi, Georgia
    - Chiesi Clinical Trial - Site 268452
  - Tbilisi, Georgia
    - Chiesi Clinical Trial - Site 268453
  - Tbilisi, Georgia
    - Chiesi Clinical Trial - Site 268454
  - Tbilisi, Georgia
    - Chiesi Clinical Trial - Site 268455
  - Tbilisi, Georgia
    - Chiesi Clinical Trial - Site 268456
  - Tbilisi, Georgia
    - Chiesi Clinical Trial - Site 268457
Germany
- - Bamberg, Germany
    - Chiesi Clinical Trial - Site 276462
  - Berlin, Germany
    - Chiesi Clinical Trial - Site 276405
  - Berlin, Germany
    - Chiesi Clinical Trial - Site 276406
  - Berlin, Germany
    - Chiesi Clinical Trial - Site 276410
  - Berlin, Germany
    - Chiesi Clinical Trial - Site 276411
  - Berlin, Germany
    - Chiesi Clinical Trial - Site 276415
  - Berlin, Germany
    - Chiesi Clinical Trial - Site 276452
  - Berlin, Germany
    - Chiesi Clinical Trial - Site 276453
  - Berlin, Germany
    - Chiesi Clinical Trial - Site 276457
  - Cottbus, Germany
    - Chiesi Clinical Trial - Site 276456
  - Darmstadt, Germany
    - Chiesi Clinical Trial - Site 276409
  - Delitzsch, Germany
    - Chiesi Clinical Trial - Site 276403
  - Essen, Germany
    - Chiesi Clinical Trial - Site 276455
  - Frankfurt, Germany
    - Chiesi Clinical Trial - Site 276404
  - Hamburg, Germany
    - Chiesi Clinical Trial - Site 276401
  - Hamburg, Germany
    - Chiesi Clinical Trial - Site 276413
  - Hanover, Germany
    - Chiesi Clinical Trial - Site 276463
  - Koblenz, Germany
    - Chiesi Clinical Trial - Site 276417
  - Leipzig, Germany
    - Chiesi Clinical Trial - Site 276402
  - Leipzig, Germany
    - Chiesi Clinical Trial - Site 276416
  - Leipzig, Germany
    - Chiesi Clinical Trial - Site 276461
  - Mainz, Germany
    - Chiesi Clinical Trial - Site 276407
  - Munich, Germany
    - Chiesi Clinical Trial - Site 276408
  - Münster, Germany
    - Chiesi Clinical Trial - Site 276459
  - Peine, Germany
    - Chiesi Clinical Trial - Site 276418
  - Schleswig, Germany
    - Chiesi Clinical Trial - Site 276464
Greece
- - Athens, Greece
    - Chiesi Clinical Trial - Site 300406
  - Heraklion, Greece
    - Chiesi Clinical Trial - Site 300401
  - Ioannina, Greece
    - Chiesi Clinical Trial - Site 300403
  - Thessaloniki, Greece
    - Chiesi Clinical Trial - Site 300404
  - Thessaloniki, Greece
    - Chiesi Clinical Trial - Site 300405
  - Volos, Greece
    - Chiesi Clinical Trial - Site 300407
Hungary
- - Balassagyarmat, Hungary
    - Chiesi Clinical Trial - Site 348406
  - Budapest, Hungary
    - Chiesi Clinical Trial - Site 348401
  - Budapest, Hungary
    - Chiesi Clinical Trial - Site 348457
  - Budapest, Hungary
    - Chiesi Clinical Trial - Site 348459
  - Csorna, Hungary
    - Chiesi Clinical Trial - Site 348405
  - Edelény, Hungary
    - Chiesi Clinical Trial - Site 348412
  - Gyula, Hungary
    - Chiesi Clinical Trial - Site 348451
  - Gödöllő, Hungary
    - Chiesi Clinical Trial - Site 348408
  - Monor, Hungary
    - Chiesi Clinical Trial - Site 348409
  - Nyíregyháza, Hungary
    - Chiesi Clinical Trial - Site 348407
  - Pécs, Hungary
    - Chiesi Clinical Trial - Site 348413
  - Sellye, Hungary
    - Chiesi Clinical Trial - Site 348452
  - Szeged, Hungary
    - Chiesi Clinical Trial - Site 348410
  - Szolnok, Hungary
    - Chiesi Clinical Trial - Site 348461
  - Szombathely, Hungary
    - Chiesi Clinical Trial - Site 348403
  - Százhalombatta, Hungary
    - Chiesi Clinical Trial - Site 348458
  - Tatabánya, Hungary
    - Chiesi Clinical Trial - Site 348453
  - Törökbálint, Hungary
    - Chiesi Clinical Trial - Site 348415
Israel
- - Ashkelon, Israel
    - Chiesi Clinical Trial - Site 376402
  - Beersheba, Israel
    - Chiesi Clinical Trial - Site 376401
  - Haifa, Israel
    - Chiesi Clinical Trial - Site 376408
  - Jerusalem, Israel
    - Chiesi Clinical Trial - Site 376403
  - Jerusalem, Israel
    - Chiesi Clinical Trial - Site 376406
  - Kfar Saba, Israel
    - Chiesi Clinical Trial - Site 376407
  - Petah Tikva, Israel
    - Chiesi Clinical Trial - Site 376405
  - Ramat Gan, Israel
    - Chiesi Clinical Trial - Site 376404
  - Tel Aviv, Israel
    - Chiesi Clinical Trial - Site 376409
  - Tel Litwinsky, Israel
    - Chiesi Clinical Trial - Site 376451
Italy
- - Brescia, Italy
    - Chiesi Clinical Trial - Site 380454
  - Catania, Italy
    - Chiesi Clinical Trial - Site 380451
  - Ferrara, Italy
    - Chiesi Clinical Trial - Site 380453
  - Roma, Italy
    - Chiesi Clinical Trial - Site 380455
  - Trieste, Italy
    - Chiesi Clinical Trial - Site 380452
Mexico
- - Chihuahua City, Mexico
    - Chiesi Clinical Trial - Site 484402
  - Chihuahua City, Mexico
    - Chiesi Clinical Trial - Site 484410
  - Córdoba, Mexico
    - Chiesi Clinical Trial - Site 484405
  - Durango, Mexico
    - Chiesi Clinical Trial - Site 484452
  - Guadalajara, Mexico
    - Chiesi Clinical Trial - Site 484401
  - Guadalajara, Mexico
    - Chiesi Clinical Trial - Site 484407
  - Guadalajara, Mexico
    - Chiesi Clinical Trial - Site 484409
  - Guadalajara, Mexico
    - Chiesi Clinical Trial - Site 484453
  - Mexico City, Mexico
    - Chiesi Clinical Trial - Site 484406
  - Monterrey, Mexico
    - Chiesi Clinical Trial - Site 484403
  - Monterrey, Mexico
    - Chiesi Clinical Trial - Site 484411
  - Veracruz, Mexico
    - Chiesi Clinical Trial - Site 484404
Netherlands
- - Almere Stad, Netherlands
    - Chiesi Clinical Trial - Site 528403
  - Beek, Netherlands
    - Chiesi Clinical Trial - Site 528401
  - Breda, Netherlands
    - Chiesi Clinical Trial - Site 528404
  - Heerlen, Netherlands
    - Chiesi Clinical Trial - Site 528402
  - Leeuwarden, Netherlands
    - Chiesi Clinical Trial - Site 528405
New Zealand
- - Christchurch, New Zealand
    - Chiesi Clinical Trial - Site 554404
  - Hamilton, New Zealand
    - Chiesi Clinical Trial - Site 554402
  - Wellington, New Zealand
    - Chiesi Clinical Trial - Site 554406
North Macedonia
- - Gostivar, North Macedonia
    - Chiesi Clinical Trial - Site 807402
  - Prilep, North Macedonia
    - Chiesi Clinical Trial - Site 807401
  - Skopje, North Macedonia
    - Chiesi Clinical Trial - Site 807452
  - Skopje, North Macedonia
    - Chiesi Clinical Trial - Site 807454
  - Struga, North Macedonia, 6330
    - General Hospital-Struga - Site 807405
  - Strumica, North Macedonia, 2400
    - General Hospital-Strumica - Site 807406
  - Tetovo, North Macedonia
    - Chiesi Clinical Trial - Site 807403
  - Veles, North Macedonia, 1400
    - General Hospital - Veles - Site 807404
Poland
- - Bialystok, Poland
    - Chiesi Clinical Trial - Site 616413
  - Bialystok, Poland
    - Chiesi Clinical Trial - Site 616418
  - Bielsko-Biala, Poland, 43-300
    - HolsaClinical - Gyncentrum Bielsko-Biala - Site 616460
  - Giżycko, Poland
    - Chiesi Clinical Trial - Site 616404
  - Katowice, Poland
    - Chiesi Clinical Trial - Site 616415
  - Katowice, Poland
    - Chiesi Clinical Trial - Site 616422
  - Krakow, Poland
    - Chiesi Clinical Trial - Site 616409
  - Krakow, Poland
    - Chiesi Clinical Trial - Site 616411
  - Krakow, Poland
    - Chiesi Clinical Trial - Site 616414
  - Krakow, Poland
    - Chiesi Clinical Trial - Site 616455
  - Lodz, Poland
    - Chiesi Clinical Trial - Site 616458
  - Lodz, Poland, 91-495
    - AmiCare Medical Centre - Site 616459
  - Lodz, Poland
    - Chiesi Clinical Trial - Site 616403
  - Lodz, Poland
    - Chiesi Clinical Trial - Site 616423
  - Lublin, Poland
    - Chiesi Clinical Trial - Site 616457
  - Ostrowiec, Poland
    - Chiesi Clinical Trial - Site 616419
  - Piaseczno, Poland
    - Chiesi Clinical Trial - Site 616456
  - Poznan, Poland
    - Chiesi Clinical Trial - Site 616406
  - Poznan, Poland
    - Chiesi Clinical Trial - Site 616408
  - Sosnowiec, Poland
    - Chiesi Clinical Trial - Site 616401
  - Tarnów, Poland
    - Chiesi Clinical Trial - Site 616451
  - Torun, Poland
    - Chiesi Clinical Trial - Site 616402
  - Wroclaw, Poland
    - Chiesi Clinical Trial - Site 616452
  - Wroclaw, Poland
    - Chiesi Clinical Trial - Site 616454
Romania
- - Bacau, Romania
    - Chiesi Clinical Trial - Site 642410
  - Bragadiru, Romania
    - Chiesi Clinical Trial - Site 642452
  - Cluj-Napoca, Romania
    - Chiesi Clinical Trial - Site 642402
  - Cluj-Napoca, Romania
    - Chiesi Clinical Trial - Site 642404
  - Cluj-Napoca, Romania
    - Chiesi Clinical Trial - Site 642406
  - Cluj-Napoca, Romania
    - Chiesi Clinical Trial - Site 642408
  - Cluj-Napoca, Romania
    - Chiesi Clinical Trial - Site 642454
  - Cluj-Napoca, Romania
    - Chiesi Clinical Trial - Site 642412
  - Constanța, Romania
    - Chiesi Clinical Trial - Site 642401
  - Craiova, Romania
    - Chiesi Clinical Trial - Site 642409
  - Craiova, Romania
    - Chiesi Clinical Trial - Site 642411
  - Deva, Romania
    - Chiesi Clinical Trial - Site 642453
  - Iași, Romania
    - Chiesi Clinical Trial - Site 642414
  - Oradea, Romania
    - Chiesi Clinical Trial - Site 642403
  - Reșca, Romania
    - Chiesi Clinical Trial - Site 642413
  - Timișoara, Romania
    - Chiesi Clinical Trial - Site 642405
  - Timișoara, Romania
    - Chiesi Clinical Trial - Site 642415
  - Timișoara, Romania
    - Chiesi Clinical Trial - Site 642407
Russia
- - Chelyabinsk, Russia
    - Chiesi Clinical Trial - Site 643433
  - Kazan', Russia
    - Chiesi Clinical Trial - Site 643417
  - Kazan', Russia
    - Chiesi Clinical Trial - Site 643462
  - Kemerovo, Russia
    - Chiesi Clinical Trial - Site 643456
  - Moscow, Russia
    - Chiesi Clinical Trial - Site 643401
  - Moscow, Russia
    - Chiesi Clinical Trial - Site 643413
  - Moscow, Russia
    - Chiesi Clinical Trial - Site 643428
  - Moscow, Russia
    - Chiesi Clinical Trial - Site 643460
  - Moskva, Russia
    - Chiesi Clinical Trial - Site 643454
  - Nizhny Novgorod, Russia
    - Chiesi Clinical Trial - Site 643416
  - Odintsovskiy, Russia
    - Chiesi Clinical Trial - Site 643403
  - Rostov-on-Don, Russia
    - Chiesi Clinical Trial - Site 643457
  - Rostov-on-Don, Russia
    - Chiesi Clinical Trial - Site 643459
  - Saint Petersburg, Russia
    - Chiesi Clinical Trial - Site 643404
  - Saint Petersburg, Russia
    - Chiesi Clinical Trial - Site 643405
  - Saint Petersburg, Russia
    - Chiesi Clinical Trial - Site 643406
  - Saint Petersburg, Russia
    - Chiesi Clinical Trial - Site 643408
  - Saint Petersburg, Russia
    - Chiesi Clinical Trial - Site 643410
  - Saint Petersburg, Russia
    - Chiesi Clinical Trial - Site 643411
  - Saint Petersburg, Russia
    - Chiesi Clinical Trial - Site 643412
  - Saint Petersburg, Russia
    - Chiesi Clinical Trial - Site 643414
  - Saint Petersburg, Russia
    - Chiesi Clinical Trial - Site 643419
  - Saint Petersburg, Russia
    - Chiesi Clinical Trial - Site 643420
  - Saint Petersburg, Russia
    - Chiesi Clinical Trial - Site 643423
  - Saint Petersburg, Russia
    - Chiesi Clinical Trial - Site 643424
  - Saint Petersburg, Russia
    - Chiesi Clinical Trial - Site 643431
  - Saint Petersburg, Russia
    - Chiesi Clinical Trial - Site 643458
  - Saint-Peterburg, Russia
    - Chiesi Clinical Trial - Site 643451
  - Saratov, Russia
    - Chiesi Clinical Trial - Site 643415
  - Saratov, Russia
    - Chiesi Clinical Trial - Site 643425
  - Ulyanovsk, Russia
    - Chiesi Clinical Trial - Site 643421
  - Voronezh, Russia
    - Chiesi Clinical Trial - Site 643402
  - Yaroslavl, Russia
    - Chiesi Clinical Trial - Site 643407
  - Yaroslavl, Russia
    - Chiesi Clinical Trial - Site 643418
  - Yaroslavl, Russia
    - Chiesi Clinical Trial - Site 643426
Serbia
- - Belgrade, Serbia, 11050
    - Kliničko Bolnički Centar Zvezdara - Site 688459
  - Belgrade, Serbia
    - Chiesi Clinical Trial - Site 688401
  - Kamenitz, Serbia, 21204
    - Institut za Plućne Bolesti Sremska Kamenica - Site 688464
  - Kamenitz, Serbia, 21204
    - Institute for Pulmonary Diseases of Vojvodina - Site 688466
  - Kragujevac, Serbia, 34000
    - Klinički Centar Kragujevac - Site 688456
  - Kragujevac, Serbia
    - Chiesi Clinical Trial - Site 688402
  - Kruševac, Serbia
    - Chiesi Clinical Trial - Site 688403
  - Niš, Serbia
    - Chiesi Clinical Trial - Site 688404
  - Niš, Serbia
    - Chiesi Clinical Trial - Site 688405
  - Užice, Serbia
    - Chiesi Clinical Trial - Site 688463
Slovakia
- - Bardejov, Slovakia
    - Chiesi Clinical Trial - Site 703401
  - Humenné, Slovakia
    - Chiesi Clinical Trial - Site 703452
  - Košice, Slovakia
    - Chiesi Clinical Trial - Site 703403
  - Levice, Slovakia
    - Chiesi Clinical Trial - Site 703453
  - Spišská Nová Ves, Slovakia
    - Chiesi Clinical Trial - Site 703402
South Africa
- - Benoni, South Africa
    - Chiesi Clinical Trial - Site 710458
  - Bloemfontein, South Africa
    - Chiesi Clinical Trial - Site 710451
  - Centurion, South Africa
    - Chiesi Clinical Trial - Site 710456
  - Durban, South Africa
    - Chiesi Clinical Trial - Site 710454
  - George, South Africa
    - Chiesi Clinical Trial - Site 710455
  - Johannesburg, South Africa
    - Chiesi Clinical Trial - Site 710453
  - Pretoria, South Africa
    - Chiesi Clinical Trial - Site 710452
Spain
- - Barakaldo, Spain
    - Chiesi Clinical Trial - Site 724454
  - Barcelona, Spain
    - Chiesi Clinical Trial - Site 724403
  - Barcelona, Spain
    - Chiesi Clinical Trial - Site 724457
  - Córdoba, Spain
    - Chiesi Clinical Trial - Site 724401
  - Madrid, Spain
    - Chiesi Clinical Trial - Site 724404
  - Madrid, Spain
    - Chiesi Clinical Trial - Site 724405
  - Madrid, Spain
    - Chiesi Clinical Trial - Site 724451
  - Palma de Mallorca, Spain
    - Chiesi Clinical Trial - Site 724455
  - Pontevedra, Spain
    - Chiesi Clinical Trial - Site 724458
  - Valencia, Spain
    - Chiesi Clinical Trial - Site 724452
  - Zaragoza, Spain
    - Chiesi Clinical Trial - Site 724402
Turkey (Türkiye)
- - Adana, Turkey (Türkiye)
    - Chiesi Clinical Trial - Site 792412
  - Bornova, Turkey (Türkiye)
    - Chiesi Clinical Trial - Site 792410
  - Istanbul, Turkey (Türkiye)
    - Chiesi Clinical Trial - Site 792408
  - Kocaeli, Turkey (Türkiye)
    - Chiesi Clinical Trial - Site 792414
  - Mersin, Turkey (Türkiye)
    - Chiesi Clinical Trial - Site 792413
  - Pamukkale, Turkey (Türkiye)
    - Chiesi Clinical Trial - Site 792406
  - Yenişehir, Turkey (Türkiye)
    - Chiesi Clinical Trial - Site 792411
  - Zeytinburnu, Turkey (Türkiye)
    - Chiesi Clinical Trial - Site 792407
  - Çanakkale, Turkey (Türkiye)
    - Chiesi Clinical Trial - Site 792415
Ukraine
- - Chernivtsi, Ukraine, 58029
    - LLC "Euromedservice" - Site 804463
  - Chernivtsi, Ukraine
    - Chiesi Clinical Trial - Site 804452
  - Dnipro, Ukraine
    - Chiesi Clinical Trial - Site 804458
  - Dnipro, Ukraine
    - Chiesi Clinical Trial - Site 804422
  - Ivano-Frankivsk, Ukraine
    - Chiesi Clinical Trial - Site 804453
  - Ivano-Frankivsk, Ukraine, 76018
    - Ivano-Frankivsk City Clinical Hospital No. 1 - Site 804453
  - Ivano-Frankivsk, Ukraine, 76018
    - The Ivano-Frankivsk National Medical Univeristy - Site 804465
  - Ivano-Frankivsk, Ukraine
    - Chiesi Clinical Trial - Site 804402
  - Kharkiv, Ukraine
    - Chiesi Clinical Trial - Site 804404
  - Kharkiv, Ukraine
    - Chiesi Clinical Trial - Site 804405
  - Kharkiv, Ukraine
    - Chiesi Clinical Trial - Site 804406
  - Kharkiv, Ukraine
    - Chiesi Clinical Trial - Site 804409
  - Kharkiv, Ukraine
    - Chiesi Clinical Trial - Site 804450
  - Kharkiv, Ukraine
    - Chiesi Clinical Trial - Site 804457
  - Kherson, Ukraine
    - Chiesi Clinical Trial - Site 804403
  - Kiev, Ukraine
    - Chiesi Clinical Trial - Site 804421
  - Kiev, Ukraine
    - Chiesi Clinical Trial - Site 804459
  - Kramatorsk, Ukraine, 84307
    - Municipal Non-profit Enterpirse-Regional Territorial Medical - Site 804454
  - Kremenchuk, Ukraine
    - Chiesi Clinical Trial - Site 804420
  - Kryvyi Rih, Ukraine
    - Chiesi Clinical Trial - Site 804451
  - Kyiv, Ukraine, 01135
    - ARENSIA Exploratory Medicine Medical Center - Site 804468
  - Kyiv, Ukraine, 02091
    - Medical Center- OkClinic of International Institute of Clinical Studies, LLC - Site 804466
  - Kyiv, Ukraine
    - Chiesi Clinical Trial - Site 804401
  - Kyiv, Ukraine
    - Chiesi Clinical Trial - Site 804408
  - Kyiv, Ukraine
    - Chiesi Clinical Trial - Site 804411
  - Kyiv, Ukraine
    - Chiesi Clinical Trial - Site 804412
  - Kyiv, Ukraine
    - Chiesi Clinical Trial - Site 804416
  - Kyiv, Ukraine
    - Chiesi Clinical Trial - Site 804460
  - Kyiv, Ukraine
    - Chiesi Clinical Trial - Site 804462
  - Odesa, Ukraine
    - Chiesi Clinical Trial - Site 804427
  - Poltava, Ukraine, 36039
    - Limited Liability Company Medical and Diagnostic Center "Medion" - Site 804407
  - Vinnytsia, Ukraine
    - Chiesi Clinical Trial - Site 804415
  - Vinnytsia, Ukraine
    - Chiesi Clinical Trial - Site 804417
  - Vinnytsia, Ukraine
    - Chiesi Clinical Trial - Site 804456
  - Vinnytsia, Ukraine
    - Chiesi Clinical Trial - Site 804455
  - Zaporizhzhia, Ukraine
    - Chiesi Clinical Trial - Site 804423
  - Zaporizhzhya, Ukraine
    - Chiesi Clinical Trial - Site 804426
  - Zhytomyr, Ukraine, 10002
    - Central City Hospital No.1 - Zhytomyr - Site 804467
United Kingdom
- - Belfast, United Kingdom
    - Chiesi Clinical Trial - Site 826410
  - Bradford, United Kingdom
    - Chiesi Clinical Trial - Site 826409
  - London, United Kingdom
    - Chiesi Clinical Trial - Site 826411
  - Rochdale, United Kingdom
    - Chiesi Clinical Trial - Site 826412
United States
- Alabama
  - Sheffield, Alabama, United States, 35660-4020
    - Chiesi Clinical Trial - Site 840402
- California
  - Northridge, California, United States, 91324-6200
    - Chiesi Clinical Trial - Site 840480
- Florida
  - Cutler Bay, Florida, United States, 33189-1230
    - Chiesi Clinical Trial - Site 840487
  - Hollywood, Florida, United States, 33021
    - Chiesi Clinical Trial - Site 840404
  - Miami, Florida, United States, 33144-2100
    - Chiesi Clinical Trial - Site 840407
  - Miami, Florida, United States, 33144
    - Chiesi Clinical Trial - Site 840444
  - Miami, Florida, United States, 33165-2075
    - Chiesi Clinical Trial - Site 840437
  - Miami, Florida, United States, 33175-3598
    - Chiesi Clinical Trial - Site 840403
  - Orlando, Florida, United States, 32822-5806
    - Chiesi Clinical Trial - Site 840463
- Georgia
  - Peachtree Corners, Georgia, United States, 30071-2656
    - Chiesi Clinical Trial - Site 840401
- New York
  - New Windsor, New York, United States, 12553-7754
    - Chiesi Clinical Trial - Site 840478
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19140
    - Chiesi Clinical Trial - Site 840483
- Texas
  - Kerrville, Texas, United States, 78028-9640
    - Chiesi Clinical Trial - Site 840474
  - Plano, Texas, United States, 75025
    - Chiesi Clinical Trial - Site 840409
  - San Antonio, Texas, United States, 78229
    - Chiesi Clinical Trial - Site 840481

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Adults aged ≥ 40 years with COPD and chronic bronchitis
Current or ex-smokers (history ≥ 10 pack years).
Post-bronchodilator FEV1 <60% of the subject predicted normal value and FEV1/FVC ratio < 0.7.
At least, one moderate or severe COPD exacerbation in previous year.
CAT score ≥ 10
Subjects on regular maintenance triple therapy for at least 12 months prior to screening and receiving regular maintenance triple therapy for at least 3 months prior to screening visit

Exclusion Criteria:

Subjects with current asthma.
Subjects with moderate or severe COPD exacerbation 4 weeks prior to study entry and randomization.
Subjects with known α-1 antitrypsin deficiency as the underlying cause of COPD.
Subjects with COPD emphysema or mixed phenotypes.
Subjects with known respiratory disorders other than COPD.
Subjects with active cancer or a history of lung cancer with full recovery less than 1 year after completing cancer therapy.
Subjects under Roflumilast treatment within 6 months before study entry.
Subjects with a diagnosis of depression, generalised anxiety disorder, suicidal ideation.
Subjects with clinically significant cardiovascular.
Subjects with a significant neurological disease.
Subjects with clinically significant laboratory abnormalities.
Subjects with moderate or severe hepatic impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CHF6001 1600µg	Drug: Experimental: CHF6001 1600µg CHF6001 400µg, 2 inhalations bid (total daily dose of 1600µg).
Experimental: CHF6001 3200µg	Drug: Experimental: CHF6001 3200µg CHF6001 800µg, 2 inhalations bid (total daily dose of 3200µg).
Placebo Comparator: CHF6001 Placebo	Drug: Placebo CHF6001 matching placebo, 2 inhalations bid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of moderate and severe COPD exacerbations occurring during the planned 52-week treatment period. Time Frame: Up to 52 weeks	Moderate or severe exacerbation is defined by symptomatic worsening of COPD: Moderate: requiring use of systemic corticosteroid (oral/IV/IM corticosteroids), and/or use of antibiotics Severe: requiring hospitalisation or resulting in death	Up to 52 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
The time to first moderate or severe exacerbation. Time Frame: Up to 52 weeks	Up to 52 weeks
The annual rate of severe exacerbation. Time Frame: Up to 52 weeks	Up to 52 weeks
The time to first severe exacerbation. Time Frame: Up to 52 weeks	Up to 52 weeks
The number of on-treatment severe exacerbations. Time Frame: Up to 52 weeks	Up to 52 weeks
Change from baseline (pre-dose visit 2) in pre-dose FEV1 at week 52. Time Frame: At Week 52	At Week 52
Change from baseline in SGRQ total and domain scores at week 52. Time Frame: At week 52	At week 52
SGRQ response (change from baseline SGRQ total score ≤ -4) at week 52. Time Frame: At week 52	At week 52
Change from baseline to last inter-visit period (week 40-52) in E-RS Total and subscale scores Time Frame: Up to 52 weeks	Up to 52 weeks
E-RS response (change from baseline E-RS Total score ≤ -2) at week 52. Time Frame: At week 52	At week 52
Change from baseline to last inter-visit period (week 40-52) in the percentage of days without intake of rescue medication and in the average rescue medication use (number of puffs) Time Frame: Up to 52 weeks	Up to 52 weeks
Time to study medication discontinuation for any reason. Time Frame: Up to 52 weeks	Up to 52 weeks
Time to moderate or severe exacerbation or study medication discontinuation due to any adverse event, lack of efficacy or death (composite endpoint) and time to study medication discontinuation component. Time Frame: Up to 52 weeks	Up to 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiesi Farmaceutici S.p.A.

Investigators

Principal Investigator: Klaus F. Rabe, Prof., LungenClinic Grosshansdorf GmbH Wöhrendamm 80 22927 Großhansdorf GERMANY

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2021

Primary Completion (Actual)

October 31, 2025

Study Completion (Actual)

October 31, 2025

Study Registration Dates

First Submitted

November 16, 2020

First Submitted That Met QC Criteria

November 16, 2020

First Posted (Actual)

November 19, 2020

Study Record Updates

Last Update Posted (Estimated)

December 17, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CLI-06001AA1-04
2020-003666-40 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Estimated)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Chronic Obstructive Pulmonary Disease

Clinical Trials on Experimental: CHF6001 1600µg

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