A 52-week, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg) Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI (Tanimilast) as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis. (PILLAR) (PILLAR)

January 30, 2026 updated by: Chiesi Farmaceutici S.p.A.

A 52-week, Randomized, Double-blind, Double-dummy, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg), 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 this study is to evaluate the efficacy and the 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)

3973

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

Argentina
- - Buenos Aires, Argentina
    - Chiesi Clinical Trial - Site 32502
  - Buenos Aires, Argentina
    - Chiesi Clinical Trial - Site 32510
  - Buenos Aires, Argentina
    - Chiesi Clinical Trial - Site 32515
  - Buenos Aires, Argentina
    - Chiesi Clinical Trial - Site 32565
  - Ciudad Autonoma Buenos Aires, Argentina
    - Chiesi Clinical Trial - Site 32514
  - Ciudad Autonoma Buenos Aires, Argentina
    - Chiesi Clinical Trial - Site 32567
  - Ciudad Autónoma de Buenos Aire, Argentina
    - Chiesi Clinical Trial - Site 32507
  - Concepción del Uruguay, Argentina
    - Chiesi Clinical Trial - Site 32563
  - Córdoba, Argentina
    - Chiesi Clinical Trial - Site 32503
  - Córdoba, Argentina
    - Chiesi Clinical Trial - Site 32509
  - Florida, Argentina
    - Chiesi Clinical Trial - Site 32501
  - Mar del Plata, Argentina
    - Chiesi Clinical Trial - Site 32562
  - Mendoza, Argentina
    - Chiesi Clinical Trial - Site 32505
  - Mendoza, Argentina
    - Chiesi Clinical Trial - Site 32511
  - Mendoza, Argentina
    - Chiesi Clinical Trial - Site 32513
  - Quilmes, Argentina
    - Chiesi Clinical Trial - Site 32506
  - Rosario, Argentina
    - Chiesi Clinical Trial - Site 32553
  - San Juan Bautista, Argentina
    - Chiesi Clinical Trial - Site 32508
  - San Miguel de Tucumán, Argentina
    - Chiesi Clinical Trial - Site 32512
  - San Miguel de Tucumán, Argentina
    - Chiesi Clinical Trial - Site 32551
  - San Miguel de Tucumán, Argentina
    - Chiesi Clinical Trial - Site 32561
  - San Miguel de Tucumán, Argentina
    - Chiesi Clinical Trial - Site 32564
  - San Rafael, Argentina
    - Chiesi Clinical Trial - Site 32566
  - Santa Fe, Argentina
    - Chiesi Clinical Trial - Site 32556
Austria
- - Feldbach, Austria
    - Chiesi Clinical Trial - Site 40502
  - Grieskirchen, Austria
    - Chiesi Clinical Trial - Site 40504
  - Linz, Austria
    - Chiesi Clinical Trial - Site 40501
  - Linz, Austria
    - Chiesi Clinical Trial - Site 40503
  - Wels, Austria
    - Chiesi Clinical Trial - Site 40505
Bosnia and Herzegovina
- - Banja Luka, Bosnia and Herzegovina
    - Chiesi Clinical Trial - Site 70553
  - Bihać, Bosnia and Herzegovina
    - Chiesi Clinical Trial - Site 70555
  - Bijeljina, Bosnia and Herzegovina
    - Chiesi Clinical Trial - Site 70554
  - Foča, Bosnia and Herzegovina
    - Chiesi Clinical Trial - Site 70557
  - Gradiška, Bosnia and Herzegovina
    - Chiesi Clinical Trial - Site 70556
  - Mostar, Bosnia and Herzegovina
    - Chiesi Clinical Trial - Site 70560
  - Mostar, Bosnia and Herzegovina
    - Chiesi Clinical Trial - Site 70562
  - Sarajevo, Bosnia and Herzegovina
    - Chiesi Clinical Trial - Site 70559
  - Sarajevo, Bosnia and Herzegovina
    - Chiesi Clinical Trial - Site 70561
  - Travnik, Bosnia and Herzegovina
    - Chiesi Clinical Trial - Site 70551
  - Trebinje, Bosnia and Herzegovina
    - Chiesi Clinical Trial - Site 70558
  - Tuzla, Bosnia and Herzegovina
    - Chiesi Clinical Trial - Site 70563
  - Zenica, Bosnia and Herzegovina
    - Chiesi Clinical Trial - Site 70552
Bulgaria
- - Blagoevgrad, Bulgaria
    - Chiesi Clinical Trial - Site 100535
  - Dimitrovgrad, Bulgaria
    - Chiesi Clinical Trial - Site 100534
  - Gabrovo, Bulgaria
    - Chiesi Clinical Trial - Site 100525
  - Haskovo, Bulgaria
    - Chiesi Clinical Trial - Site 100523
  - Kozloduy, Bulgaria
    - Chiesi Clinical Trial - Site 100533
  - Lovech, Bulgaria
    - Chiesi Clinical Trial - Site 100527
  - Montana, Bulgaria
    - Chiesi Clinical Trial - Site 100515
  - Pernik, Bulgaria
    - Chiesi Clinical Trial - Site 100532
  - Pleven, Bulgaria
    - Chiesi Clinical Trial - Site 100522
  - Plovdiv, Bulgaria
    - Chiesi Clinical Trial - Site 100529
  - Razgrad, Bulgaria
    - Chiesi Clinical Trial - Site 100537
  - Rousse, Bulgaria
    - Chiesi Clinical Trial - Site 100512
  - Rousse, Bulgaria
    - Chiesi Clinical Trial - Site 100516
  - Sevlievo, Bulgaria
    - Chiesi Clinical Trial - Site 100536
  - Sofia, Bulgaria
    - Chiesi Clinical Trial - Site 100501
  - Sofia, Bulgaria
    - Chiesi Clinical Trial - Site 100509
  - Sofia, Bulgaria
    - Chiesi Clinical Trial - Site 100514
  - Sofia, Bulgaria
    - Chiesi Clinical Trial - Site 100517
  - Sofia, Bulgaria
    - Chiesi Clinical Trial - Site 100518
  - Sofia, Bulgaria
    - Chiesi Clinical Trial - Site 100530
  - Sofia, Bulgaria
    - Chiesi Clinical Trial - Site 100531
  - Sofia, Bulgaria
    - Chiesi Clinical Trial - Site 100538
  - Stara Zagora, Bulgaria
    - Chiesi Clinical Trial - Site 100524
  - Vidin, Bulgaria
    - Chiesi Clinical Trial - Site 100519
  - Vidin, Bulgaria
    - Chiesi Clinical Trial - Site 100557
Chile
- - Concepción, Chile
    - Chiesi Clinical Trial - Site 152506
  - Quillota, Chile
    - Chiesi Clinical Trial - Site 152507
  - Santiago, Chile
    - Chiesi Clinical Trial - Site 152503
  - Santiago, Chile
    - Chiesi Clinical Trial - Site 152504
  - Santiago, Chile
    - Chiesi Clinical Trial - Site 152508
  - Talca, Chile
    - Chiesi Clinical Trial - Site 152509
  - Valparaíso, Chile
    - Chiesi Clinical Trial - Site 152501
Croatia
- - Dubrovnik, Croatia
    - Chiesi Clinical Trial - Site 191562
  - Karlovac, Croatia
    - Chiesi Clinical Trial - Site 191552
  - Osijek, Croatia
    - Chiesi Clinical Trial - Site 191557
  - Rijeka, Croatia
    - Chiesi Clinical Trial - Site 191561
  - Rijeka, Croatia
    - Chiesi Clinical Trial - Site 191563
  - Sisak, Croatia
    - Chiesi Clinical Trial - Site 191553
  - Split, Croatia
    - Chiesi Clinical Trial - Site 191558
  - Zadar, Croatia
    - Chiesi Clinical Trial - Site 191555
  - Zagreb, Croatia
    - Chiesi Clinical Trial - Site 191551
  - Zagreb, Croatia
    - Chiesi Clinical Trial - Site 191554
  - Zagreb, Croatia
    - Chiesi Clinical Trial - Site 191556
  - Zagreb, Croatia
    - Chiesi Clinical Trial - Site 191559
  - Zagreb, Croatia
    - Chiesi Clinical Trial - Site 191560
Czechia
- - Brandýs nad Labem, Czechia
    - Chiesi Clinical Trial - Site 203551
  - Havlíčkův Brod, Czechia
    - Chiesi Clinical Trial - Site 203518
  - Jindřichův Hradec, Czechia
    - Chiesi Clinical Trial - Site 203501
  - Miroslav, Czechia
    - Chiesi Clinical Trial - Site 203504
  - Mladá Boleslav, Czechia
    - Chiesi Clinical Trial - Site 203516
  - Měšice, Czechia
    - Chiesi Clinical Trial - Site 203517
  - Prague, Czechia
    - Chiesi Clinical Trial - Site 203505
  - Prague, Czechia
    - Chiesi Clinical Trial - Site 203507
  - Prague, Czechia
    - Chiesi Clinical Trial - Site 203513
  - Prague, Czechia
    - Chiesi Clinical Trial - Site 203515
Estonia
- - Narva, Estonia
    - Chiesi Clinical Trial - Site 372553
  - Tallinn, Estonia
    - Chiesi Clinical Trial - Site 372551
  - Tartu, Estonia
    - Chiesi Clinical Trial - Site 372552
Germany
- - Berlin, Germany
    - Chiesi Clinical Trial - Site 276505
  - Berlin, Germany
    - Chiesi Clinical Trial - Site 276506
  - Berlin, Germany
    - Chiesi Clinical Trial - Site 276510
  - Berlin, Germany
    - Chiesi Clinical Trial - Site 276511
  - Berlin, Germany
    - Chiesi Clinical Trial - Site 276515
  - Cottbus, Germany
    - Chiesi Clinical Trial - Site 276556
  - Darmstadt, Germany
    - Chiesi Clinical Trial - Site 276509
  - Delitzsch, Germany
    - Chiesi Clinical Trial - Site 276503
  - Frankfurt am Main, Germany
    - Chiesi Clinical Trial - Site 276504
  - Geesthacht, Germany
    - Chiesi Clinical Trial - Site 276557
  - Hamburg, Germany
    - Chiesi Clinical Trial - Site 276501
  - Hamburg, Germany
    - Chiesi Clinical Trial - Site 276513
  - Hamburg, Germany
    - Chiesi Clinical Trial - Site 276514
  - Hanover, Germany
    - Chiesi Clinical Trial - Site 276558
  - Koblenz, Germany
    - Chiesi Clinical Trial - Site 276517
  - Leipzig, Germany
    - Chiesi Clinical Trial - Site 276502
  - Leipzig, Germany
    - Chiesi Clinical Trial - Site 276516
  - Leipzig, Germany
    - Chiesi Clinical Trial - Site 276551
  - Mainz, Germany
    - Chiesi Clinical Trial - Site 276507
  - Munich, Germany
    - Chiesi Clinical Trial - Site 276508
  - Peine, Germany
    - Chiesi Clinical Trial - Site 276518
Greece
- - Athens, Greece
    - Chiesi Clinical Trial - Site 300506
  - Chortiatis, Greece
    - Chiesi Clinical Trial - Site 300504
  - Heraklion, Greece
    - Chiesi Clinical Trial - Site 300501
  - Ioannina, Greece
    - Chiesi Clinical Trial - Site 300503
  - Thessaloniki, Greece
    - Chiesi Clinical Trial - Site 300505
  - Volos, Greece
    - Chiesi Clinical Trial - Site 300507
Hungary
- - Balassagyarmat, Hungary
    - Chiesi Clinical Trial - Site 348506
  - Budapest, Hungary
    - Chiesi Clinical Trial - Site 348501
  - Csorna, Hungary
    - Chiesi Clinical Trial - Site 348505
  - Edelény, Hungary
    - Chiesi Clinical Trial - Site 348512
  - Gödöllő, Hungary
    - Chiesi Clinical Trial - Site 348508
  - Monor, Hungary
    - Chiesi Clinical Trial - Site 348509
  - Nyíregyháza, Hungary
    - Chiesi Clinical Trial - Site 348507
  - Pécs, Hungary
    - Chiesi Clinical Trial - Site 348513
  - Sellye, Hungary
    - Chiesi Clinical Trial - Site 348552
  - Szeged, Hungary
    - Chiesi Clinical Trial - Site 348510
  - Szombathely, Hungary
    - Chiesi Clinical Trial - Site 348503
  - Törökbálint, Hungary
    - Chiesi Clinical Trial - Site 348515
Israel
- - Ashkelon, Israel
    - Chiesi Clinical Trial - Site 376502
  - Beersheba, Israel
    - Chiesi Clinical Trial - Site 376501
  - Hadera, Israel
    - Chiesi Clinical Trial - Site 376511
  - Haifa, Israel
    - Chiesi Clinical Trial - Site 376508
  - Haifa, Israel
    - Chiesi Clinical Trial - Site 376510
  - Jerusalem, Israel
    - Chiesi Clinical Trial - Site 376503
  - Jerusalem, Israel
    - Chiesi Clinical Trial - Site 376506
  - Kfar Saba, Israel
    - Chiesi Clinical Trial - Site 376507
  - Ramat Gan, Israel
    - Chiesi Clinical Trial - Site 376504
  - Tel Aviv, Israel
    - Chiesi Clinical Trial - Site 376509
Latvia
- - Balvi, Latvia
    - Chiesi Clinical Trial - Site 371557
  - Daugavpils, Latvia
    - Chiesi Clinical Trial - Site 371553
  - Daugavpils, Latvia
    - Chiesi Clinical Trial - Site 371554
  - Jūrmala, Latvia
    - Chiesi Clinical Trial - Site 371555
  - Riga, Latvia
    - Chiesi Clinical Trial - Site 371551
  - Riga, Latvia
    - Chiesi Clinical Trial - Site 371552
  - Riga, Latvia
    - Chiesi Clinical Trial - Site 371556
  - Rēzekne, Latvia
    - Chiesi Clinical Trial - Site 371558
Mexico
- - Chihuahua City, Mexico
    - Chiesi Clinical Trial - Site 484502
  - Chihuahua City, Mexico
    - Chiesi Clinical Trial - Site 484510
  - Cuauhtémoc, Mexico
    - Chiesi Clinical Trial - Site 484506
  - Córdoba, Mexico
    - Chiesi Clinical Trial - Site 484505
  - Guadalajara, Mexico
    - Chiesi Clinical Trial - Site 484501
  - Guadalajara, Mexico
    - Chiesi Clinical Trial - Site 484507
  - Guadalajara, Mexico
    - Chiesi Clinical Trial - Site 484509
  - Monterrey, Mexico
    - Chiesi Clinical Trial - Site 484503
  - Monterrey, Mexico
    - Chiesi Clinical Trial - Site 484511
  - Veracruz, Mexico
    - Chiesi Clinical Trial - Site 484504
Netherlands
- - Beek, Netherlands
    - Chiesi Clinical Trial - Site 528501
  - Breda, Netherlands
    - Chiesi Clinical Trial - Site 528504
  - Heerlen, Netherlands
    - Chiesi Clinical Trial - Site 528502
  - Leeuwarden, Netherlands
    - Chiesi Clinical Trial - Site 528505
New Zealand
- - Christchurch, New Zealand
    - Chiesi Clinical Trial - Site 554504
  - Hamilton, New Zealand
    - Chiesi Clinical Trial - Site 554502
  - Tauranga, New Zealand
    - Chiesi Clinical Trial - Site 554503
North Macedonia
- - Bitola, North Macedonia
    - Chiesi Clinical Trial - Site 807555
  - Gevgelija, North Macedonia
    - Chiesi Clinical Trial - Site 807559
  - Ohrid, North Macedonia
    - Chiesi Clinical Trial - Site 807557
  - Shtip, North Macedonia
    - Chiesi Clinical Trial - Site 807553
  - Skopje, North Macedonia
    - Chiesi Clinical Trial - Site 807552
  - Skopje, North Macedonia
    - Chiesi Clinical Trial - Site 807554
  - Skopje, North Macedonia
    - Chiesi Clinical Trial - Site 807556
Poland
- - Bialystok, Poland
    - Chiesi Clinical Trial - Site 616518
  - Giżycko, Poland
    - Chiesi Clinical Trial - Site 616504
  - Katowice, Poland
    - Chiesi Clinical Trial - Site 616515
  - Katowice, Poland
    - Chiesi Clinical Trial - Site 616522
  - Krakow, Poland
    - Chiesi Clinical Trial - Site 616509
  - Krakow, Poland
    - Chiesi Clinical Trial - Site 616511
  - Krakow, Poland
    - Chiesi Clinical Trial - Site 616514
  - Lodz, Poland
    - Chiesi Clinical Trial - Site 616503
  - Lodz, Poland
    - Chiesi Clinical Trial - Site 616523
  - Ostrowiec Świętokrzyski, Poland
    - Chiesi Clinical Trial - Site 616519
  - Poznan, Poland
    - Chiesi Clinical Trial - Site 616506
  - Poznan, Poland
    - Chiesi Clinical Trial - Site 616508
  - Sosnowiec, Poland
    - Chiesi Clinical Trial - Site 616501
  - Torun, Poland
    - Chiesi Clinical Trial - Site 616502
  - Wroclaw, Poland
    - Chiesi Clinical Trial - Site 616554
Romania
- - Bacau, Romania
    - Chiesi Clinical Trial - Site 642510
  - Brasov, Romania
    - Chiesi Clinical Trial - Site 642551
  - Cluj-Napoca, Romania
    - Chiesi Clinical Trial - Site 642502
  - Cluj-Napoca, Romania
    - Chiesi Clinical Trial - Site 642504
  - Cluj-Napoca, Romania
    - Chiesi Clinical Trial - Site 642512
  - Cluj-Napoca, Romania
    - Chiesi Clinical Trial - Site 642554
  - Cluj-Napoca Cluj, Romania
    - Chiesi Clinical Trial - Site 642506
  - Cluj-Napoca Cluj, Romania
    - Chiesi Clinical Trial - Site 642508
  - Constanța, Romania
    - Chiesi Clinical Trial - Site 642501
  - Craiova, Romania
    - Chiesi Clinical Trial - Site 642509
  - Craiova, Romania
    - Chiesi Clinical Trial - Site 642511
  - Iași, Romania
    - Chiesi Clinical Trial - Site 642514
  - Oradea, Romania
    - Chiesi Clinical Trial - Site 642503
  - Reșca, Romania
    - Chiesi Clinical Trial - Site 642513
  - Timișoara, Romania
    - Chiesi Clinical Trial - Site 642505
  - Timișoara, Romania
    - Chiesi Clinical Trial - Site 642507
  - Timișoara, Romania
    - Chiesi Clinical Trial - Site 642515
Russia
- - Kazan', Russia
    - Chiesi Clinical Trial - Site 643517
  - Moscow, Russia
    - Chiesi Clinical Trial - Site 643513
  - Moscow, Russia
    - Chiesi Clinical Trial - Site 643528
  - Nizhny Novgorod, Russia
    - Chiesi Clinical Trial - Site 643516
  - Odintsovskiy, Russia
    - Chiesi Clinical Trial - Site 643503
  - Saint Petersburg, Russia
    - Chiesi Clinical Trial - Site 643504
  - Saint Petersburg, Russia
    - Chiesi Clinical Trial - Site 643505
  - Saint Petersburg, Russia
    - Chiesi Clinical Trial - Site 643506
  - Saint Petersburg, Russia
    - Chiesi Clinical Trial - Site 643508
  - Saint Petersburg, Russia
    - Chiesi Clinical Trial - Site 643510
  - Saint Petersburg, Russia
    - Chiesi Clinical Trial - Site 643511
  - Saint Petersburg, Russia
    - Chiesi Clinical Trial - Site 643512
  - Saint Petersburg, Russia
    - Chiesi Clinical Trial - Site 643514
  - Saint Petersburg, Russia
    - Chiesi Clinical Trial - Site 643519
  - Saint Petersburg, Russia
    - Chiesi Clinical Trial - Site 643520
  - Saint Petersburg, Russia
    - Chiesi Clinical Trial - Site 643531
  - Saratov, Russia
    - Chiesi Clinical Trial - Site 643515
  - Saratov, Russia
    - Chiesi Clinical Trial - Site 643525
  - Ulyanovsk, Russia
    - Chiesi Clinical Trial - Site 643521
  - Voronezh, Russia
    - Chiesi Clinical Trial - Site 643502
  - Vsevolozhsk, Russia
    - Chiesi Clinical Trial - Site 643524
  - Yaroslavl, Russia
    - Chiesi Clinical Trial - Site 643507
  - Yaroslavl, Russia
    - Chiesi Clinical Trial - Site 643518
Serbia
- - Belgrade, Serbia
    - Chiesi Clinical Trial - Site 688552
  - Belgrade, Serbia
    - Chiesi Clinical Trial - Site 688553
  - Belgrade, Serbia
    - Chiesi Clinical Trial - Site 688555
  - Belgrade, Serbia
    - Chiesi Clinical Trial - Site 688557
  - Belgrade, Serbia
    - Chiesi Clinical Trial - Site 688558
  - Belgrade, Serbia
    - Chiesi Clinical Trial - Site 688559
  - Belgrade, Serbia
    - Chiesi Clinical Trial - Site 688561
  - Belgrade, Serbia
    - Chiesi Clinical Trial - Site 688569
  - Jagodina, Serbia
    - Chiesi Clinical Trial - Site 688570
  - Kamenitz, Serbia
    - Chiesi Clinical Trial - Site 688564
  - Kamenitz, Serbia
    - Chiesi Clinical Trial - Site 688566
  - Kragujevac, Serbia
    - Chiesi Clinical Trial - Site 688556
  - Leskovac, Serbia
    - Chiesi Clinical Trial - Site 688562
  - Niš, Serbia
    - Chiesi Clinical Trial - Site 688554
  - Niš, Serbia
    - Chiesi Clinical Trial - Site 688568
  - Pančevo, Serbia
    - Chiesi Clinical Trial - Site 688567
  - Paraćin, Serbia
    - Chiesi Clinical Trial - Site 688560
  - Sombor, Serbia
    - Chiesi Clinical Trial - Site 688551
  - Sremska Mitrovica, Serbia
    - Chiesi Clinical Trial - Site 688571
  - Užice, Serbia
    - Chiesi Clinical Trial - Site 688563
  - Valjevo, Serbia
    - Chiesi Clinical Trial - Site 688565
Slovakia
- - Bardejov, Slovakia
    - Chiesi Clinical Trial - Site 703501
  - Košice, Slovakia
    - Chiesi Clinical Trial - Site 703503
  - Spišská Nová Ves, Slovakia
    - Chiesi Clinical Trial - Site 703502
South Korea
- - Anyang-si, South Korea
    - Chiesi Clinical Trial - Site 408556
  - Daegu, South Korea
    - Chiesi Clinical Trial - Site 408551
  - Dongjak, South Korea
    - Chiesi Clinical Trial - Site 408560
  - Gwangju, South Korea
    - Chiesi Clinical Trial - Site 408554
  - Haeundae, South Korea
    - Chiesi Clinical Trial - Site 408559
  - Incheon, South Korea
    - Chiesi Clinical Trial - Site 408557
  - Incheon, South Korea
    - Chiesi Clinical Trial - Site 408558
  - Jeonju, South Korea
    - Chiesi Clinical Trial - Site 408555
  - Seoul, South Korea
    - Chiesi Clinical Trial - Site 408552
  - Seoul, South Korea
    - Chiesi Clinical Trial - Site 408553
  - Suwon,Gyeonggi-do, South Korea
    - Chiesi Clinical Trial - Site 408561
Spain
- - Barcelona, Spain
    - Chiesi Clinical Trial - Site 724503
  - Córdoba, Spain
    - Chiesi Clinical Trial - Site 724501
  - Madrid, Spain
    - Chiesi Clinical Trial - Site 724505
  - Madrid, Spain
    - Chiesi Clinical Trial - Site 724551
  - Majadahonda, Spain
    - Chiesi Clinical Trial - Site 724504
  - Zaragoza, Spain
    - Chiesi Clinical Trial - Site 724502
Turkey (Türkiye)
- - Adana, Turkey (Türkiye)
    - Chiesi Clinical Trial - Site 792512
  - Bornova, Turkey (Türkiye)
    - Chiesi Clinical Trial - Site 792510
  - Istanbul, Turkey (Türkiye)
    - Chiesi Clinical Trial - Site 792507
  - Kocaeli, Turkey (Türkiye)
    - Chiesi Clinical Trial - Site 792514
  - Mersin, Turkey (Türkiye)
    - Chiesi Clinical Trial - Site 792513
  - Pamukkale, Turkey (Türkiye)
    - Chiesi Clinical Trial - Site 792506
  - Pendik, Turkey (Türkiye)
    - Chiesi Clinical Trial - Site 792508
  - Yenişehir, Turkey (Türkiye)
    - Chiesi Clinical Trial - Site 792511
  - Çanakkale, Turkey (Türkiye)
    - Chiesi Clinical Trial - Site 792551
Ukraine
- - Dnipro, Ukraine
    - Chiesi Clinical Trial - Site 804522
  - Ivano-Frankivsk, Ukraine
    - Chiesi Clinical Trial - Site 804502
  - Kharkiv, Ukraine
    - Chiesi Clinical Trial - Site 804504
  - Kharkiv, Ukraine
    - Chiesi Clinical Trial - Site 804505
  - Kharkiv, Ukraine
    - Chiesi Clinical Trial - Site 804506
  - Kharkiv, Ukraine
    - Chiesi Clinical Trial - Site 804509
  - Kherson, Ukraine
    - Chiesi Clinical Trial - Site 804503
  - Kiev, Ukraine
    - Chiesi Clinical Trial - Site 804511
  - Kremenchuk, Ukraine
    - Chiesi Clinical Trial - Site 804520
  - Kyiv, Ukraine
    - Chiesi Clinical Trial - Site 804501
  - Kyiv, Ukraine
    - Chiesi Clinical Trial - Site 804508
  - Kyiv, Ukraine
    - Chiesi Clinical Trial - Site 804512
  - Kyiv, Ukraine
    - Chiesi Clinical Trial - Site 804516
  - Kyiv, Ukraine
    - Chiesi Clinical Trial - Site 804518
  - Kyiv, Ukraine
    - Chiesi Clinical Trial - Site 804521
  - Odesa, Ukraine
    - Chiesi Clinical Trial - Site 804527
  - Poltava, Ukraine
    - Chiesi Clinical Trial - Site 804507
  - Vinnytsia, Ukraine
    - Chiesi Clinical Trial - Site 804515
  - Vinnytsia, Ukraine
    - Chiesi Clinical Trial - Site 804517
  - Zaporizhia, Ukraine
    - Chiesi Clinical Trial - Site 804528
United Kingdom
- - Belfast, United Kingdom
    - Chiesi Clinical Trial - Site 826510
  - Bradford, United Kingdom
    - Chiesi Clinical Trial - Site 826509
  - London, United Kingdom
    - Chiesi Clinical Trial - Site 826511
  - Rochdale, United Kingdom
    - Chiesi Clinical Trial - Site 826512
United States
- Alabama
  - Andalusia, Alabama, United States, 36420-5310
    - Chiesi Clinical Trial - Site 840635
  - Foley, Alabama, United States, 36535-2248
    - Chiesi Clinical Trial - Site 840614
  - Guntersville, Alabama, United States, 35976-2206
    - Chiesi Clinical Trial - Site 840670
  - Mobile, Alabama, United States, 36608
    - Chiesi Clinical Trial - Site 840720
  - Saraland, Alabama, United States, 36571-3014
    - Chiesi Clinical Trial - Site 840643
- Arizona
  - Phoenix, Arizona, United States, 85018-5434
    - Chiesi Clinical Trial - Site 840638
- Arkansas
  - Conway, Arkansas, United States, 72032
    - Chiesi Clinical Trial - Site 840684
- California
  - Laguna Hills, California, United States, 92653-5509
    - Chiesi Clinical Trial - Site 840675
  - Los Angeles, California, United States, 90017-5649
    - Chiesi Clinical Trial - Site 840666
  - Newport Beach, California, United States, 92663-3661
    - Chiesi Clinical Trial - Site 840511
  - Northridge, California, United States, 91324-6200
    - Chiesi Clinical Trial - Site 840680
  - Northridge, California, United States, 91324
    - Chiesi Clinical Trial - Site 840605
  - Pomona, California, United States, 91768
    - Chiesi Clinical Trial - Site 840700
  - Westminster, California, United States, 92708
    - Chiesi Clinical Trial - Site 840531
- Colorado
  - Centennial, Colorado, United States, 80112-1406
    - Chiesi Clinical Trial - Site 840636
  - Lakewood, Colorado, United States, 80228
    - Chiesi Clinical Trial - Site 840688
- Florida
  - Brooksville, Florida, United States, 34613
    - Chiesi Clinical Trial - Site 840735
  - Chiefland, Florida, United States, 32626
    - Chiesi Clinical Trial - Site 840513
  - Clearwater, Florida, United States, 33756
    - Chiesi Clinical Trial - Site 840652
  - Clearwater, Florida, United States, 33765-2103
    - Chiesi Clinical Trial - Site 840569
  - Coral Gables, Florida, United States, 33135
    - Chiesi Clinical Trial - Site 840545
  - Cutler Bay, Florida, United States, 33144-2566
    - Chiesi Clinical Trial - Site 840603
  - Cutler Bay, Florida, United States, 33189-1230
    - Chiesi Clinical Trial - Site 840587
  - Cutler Bay, Florida, United States, 33189
    - Chiesi Clinical Trial - Site 840568
  - Daytona Beach, Florida, United States, 33470-9216
    - Chiesi Clinical Trial - Site840539
  - DeBary, Florida, United States, 32713-2260
    - Chiesi Clinical Trial - Site 840554
  - Doral, Florida, United States, 33014-2426
    - Chiesi Clinical Trial - Site 840625
  - Doral, Florida, United States, 33122-1902
    - Chiesi Clinical Trial - Site 840572
  - Hialeah, Florida, United States, 33010-4103
    - Chiesi Clinical Trial - Site 840685
  - Hialeah, Florida, United States, 33012-3618
    - Chiesi Clinical Trial - Site 840504
  - Hialeah, Florida, United States, 33015-2952
    - Chiesi Clinical Trial - Site 840639
  - Hialeah, Florida, United States, 33015-6003
    - Chiesi Clinical Trial - Site 840582
  - Hialeah, Florida, United States, 33016-2753
    - Chiesi Clinical Trial - Site 840617
  - Hialeah, Florida, United States, 33186-5331
    - Chiesi Clinical Trial - Site 840514
  - Hialeah Gardens, Florida, United States, 33016
    - Chiesi Clinical Trial - Site 840637
  - Hollywood, Florida, United States, 33021
    - Chiesi Clinical Trial - Site 840509
  - Hollywood, Florida, United States, 33024
    - Chiesi Clinical Trial - Site 840730
  - Homestead, Florida, United States, 33256
    - Chiesi Clinical Trial - Site 840565
  - Loxahatchee Groves, Florida, United States, 33470
    - Chiesi Clinical Trial - Site 840674
  - Melbourne, Florida, United States, 32934
    - Chiesi Clinical Trial - Site 840732
  - Miami, Florida, United States, 33125-5114
    - Chiesi Clinical Trial - Site 840624
  - Miami, Florida, United States, 33126-1921
    - Chiesi Clinical Trial - Site 840596
  - Miami, Florida, United States, 33126-1926
    - Chiesi Clinical Trial - Site 840556
  - Miami, Florida, United States, 33135-2967
    - Chiesi Clinical Trial - Site 840602
  - Miami, Florida, United States, 33144-2100
    - Chiesi Clinical Trial - Site 840507
  - Miami, Florida, United States, 33144-4273
    - Chiesi Clinical Trial - Site 840519
  - Miami, Florida, United States, 33144-5037
    - Chiesi Clinical Trial - Site 840505
  - Miami, Florida, United States, 33144
    - Chiesi Clinical Trial - Site 840644
  - Miami, Florida, United States, 33155-1694
    - Chiesi Clinical Trial - Site 840557
  - Miami, Florida, United States, 33155-4630
    - Chiesi Clinical Trial - Site 840588
  - Miami, Florida, United States, 33155-6538
    - Chiesi Clinical Trial - Site 840618
  - Miami, Florida, United States, 33155-6541
    - Chiesi Clinical Trial - Site 840525
  - Miami, Florida, United States, 33155-6542
    - Chiesi Clinical Trial - Site 840656
  - Miami, Florida, United States, 33155
    - Chiesi Clinical Trial - Site 840622
  - Miami, Florida, United States, 33165-2075
    - Chiesi Clinical Trial - Site 840537
  - Miami, Florida, United States, 33165-2470
    - Chiesi Clinical Trial - Site 840691
  - Miami, Florida, United States, 33175-3598
    - Chiesi Clinical Trial - Site 840503
  - Miami, Florida, United States, 33184-1176
    - Chiesi Clinical Trial - Site 840694
  - Miami, Florida, United States, 33185
    - Chiesi Clinical Trial - Site 840630
  - Miami Gardens, Florida, United States, 33014-6426
    - Chiesi Clinical Trial - Site 840506
  - Miami Lakes, Florida, United States, 33014-2425
    - Chiesi Clinical Trial - Site 840608
  - Orlando, Florida, United States, 32807-3555
    - Chiesi Clinical Trial - Site 840524
  - Orlando, Florida, United States, 32825
    - Chiesi Clinical Trial - Site 840563
  - Pembroke Pines, Florida, United States, 14000
    - Chiesi Clinical Trial - Site 840702
  - Pembroke Pines, Florida, United States, 33024-3618
    - Chiesi Clinical Trial - Site 840502
  - Pembroke Pines, Florida, United States, 33024-6442
    - Chiesi Clinical Trial - Site 840550
  - Pompano Beach, Florida, United States, 33064-3547
    - Chiesi Clinical Trial - Site 840527
  - South Miami, Florida, United States, 33143-4960
    - Chiesi Clinical Trial - Site 840654
  - St. Petersburg, Florida, United States, 33707-6129
    - Chiesi Clinical Trial - Site 840699
  - St. Petersburg, Florida, United States, 33713-8900
    - Chiesi Clinical Trial - Site 840697
  - Tampa, Florida, United States, 33613-3740
    - Chiesi Clinical Trial - Site 840567
  - Winter Park, Florida, United States, 32789
    - Chiesi Clinical Trial - Site 840632
- Georgia
  - Adairsville, Georgia, United States, 30103-2438
    - Chiesi Clinical Trial - Site 840542
  - College Park, Georgia, United States, 30349
    - Chiesi Clinical Trial - Site 840728
  - Columbus, Georgia, United States, 31904
    - Chiesi Clinical Trial - Site 840717
  - Cordele, Georgia, United States, 31015
    - Chiesi Clinical Trial - Site 840710
  - East Point, Georgia, United States, 30344
    - Chiesi Clinical Trial - Site 840689
  - Stonecrest, Georgia, United States, 30038
    - Chiesi Clinical Trial - Site 840726
  - Valdosta, Georgia, United States, 31605-1096
    - Chiesi Clinical Trial - Site 840564
- Indiana
  - Muncie, Indiana, United States, 46303
    - Chiesi Clinical Trial - Site 840724
- Louisiana
  - Zachary, Louisiana, United States, 70791-4010
    - Chiesi Clinical Trial - Site 840672
- Maryland
  - Annapolis, Maryland, United States, 21401
    - Chiesi Clinical Trial - Site 840645
  - Baltimore, Maryland, United States, 21224-6821
    - Chiesi Clinical Trial - Site 840661
- Massachusetts
  - North Dartmouth, Massachusetts, United States, 02747-1271
    - Chiesi Clinical Trial - Site 840707
- Michigan
  - Troy, Michigan, United States, 48085
    - Chiesi Clinical Trial - Site 840657
- Mississippi
  - Port Gibson, Mississippi, United States, 39150
    - Chiesi Clinical Trial - Site 840658
- Missouri
  - Saint Charles, Missouri, United States, 63301-2835
    - Chiesi Clinical Trial - Site 840641
  - St Louis, Missouri, United States, 63110
    - Chiesi Clinical Trial - Site 840714
  - St Louis, Missouri, United States, 63141
    - Chiesi Clinical Trial - Site 840541
  - St Louis, Missouri, United States, 63141
    - Chiesi Clinical Trial - Site 840669
- Nebraska
  - Omaha, Nebraska, United States, 68178
    - Chiesi Clinical Trial - Site 840686
- Nevada
  - Henderson, Nevada, United States, 89052
    - Chiesi Clinical Trial - Site 840703
  - Las Vegas, Nevada, United States, 89106-4159
    - Chiesi Clinical Trial - Site 840529
  - North Las Vegas, Nevada, United States, 89030-7193
    - Chiesi Clinical Trial - Site 840701
- New Jersey
  - Bayonne, New Jersey, United States, 07002
    - Chiesi Clinical Trial - Site 840722
- New York
  - Buffalo, New York, United States, 14203-1070
    - Chiesi Clinical Trial - Site 840667
  - New Windsor, New York, United States, 12553-7754
    - Chiesi Clinical Trial - Site 840678
  - New York, New York, United States, 10021-0005
    - Chiesi Clinical Trial - Site 840520
  - New York, New York, United States, 10029-6500
    - Chiesi Clinical Trial - Site 840705
  - The Bronx, New York, United States, 10455
    - Chiesi Clinical Trial - Site 840626
  - The Bronx, New York, United States, 10468-6401
    - Chiesi Clinical Trial - Site 840604
- North Carolina
  - Charlotte, North Carolina, United States, 28210-0106
    - Chiesi Clinical Trial - Site 840664
  - Charlotte, North Carolina, United States, 28273
    - Chiesi Clinical Trial - Site 840721
  - Denver, North Carolina, United States, 28037-7930
    - Chiesi Clinical Trial - Site 840610
  - Gastonia, North Carolina, United States, 28054-7481
    - Chiesi Clinical Trial - Site 840659
  - Huntersville, North Carolina, United States, 28078-5082
    - Chiesi Clinical Trial - Site 840540
  - New Bern, North Carolina, United States, 28562-5238
    - Chiesi Clinical Trial - Site 840523
  - Shelby, North Carolina, United States, 28150
    - Chiesi Clinical Trial - Site 840708
  - Winston-Salem, North Carolina, United States, 27103
    - Chiesi Clinical Trial - Site 840621
- Ohio
  - Cincinnati, Ohio, United States, 45236
    - Chiesi Clinical Trial - Site 840627
  - Columbus, Ohio, United States, 43228
    - Chiesi Clinical Trial - Site 840713
  - Dayton, Ohio, United States, 45419-4336
    - Chiesi Clinical Trial - Site 840647
  - Toledo, Ohio, United States, 43617-1178
    - Chiesi Clinical Trial - Site 840646
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - Chiesi Clinical Trial - Site 840668
  - Tulsa, Oklahoma, United States, 74133-5829
    - Chiesi Clinical Trial - Site 840692
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19107-5109
    - Chiesi Clinical Trial - Site 840671
  - Philadelphia, Pennsylvania, United States, 19140
    - Chiesi Clinical Trial - Site 840683
- South Carolina
  - Anderson, South Carolina, United States, 29621-4822
    - Chiesi Clinical Trial - Site 840578
  - Charleston, South Carolina, United States, 29412-2625
    - Chiesi Clinical Trial - Site 840592
  - Fort Mill, South Carolina, United States, 29701
    - Chiesi Clinical Trial - Site 840528
  - North Charleston, South Carolina, United States, 29420
    - Chiesi Clinical Trial - Site 840598
  - Rock Hill, South Carolina, United States, 29732-1160
    - Chiesi Clinical Trial - Site 840696
- Tennessee
  - Franklin, Tennessee, United States, 37067
    - Chiesi Clinical Trial - Site 840660
  - Franklin, Tennessee, United States, 38305
    - Chiesi Clinical Trial - Site 840546
  - Knoxville, Tennessee, United States, 37909-1161
    - Chiesi Clinical Trial - Site 840553
- Texas
  - Baytown, Texas, United States, 77521-2416
    - Chiesi Clinical Trial - Site 840535
  - Boerne, Texas, United States, 78006-1993
    - Chiesi Clinical Trial - Site 840634
  - Carrollton, Texas, United States, 14000
    - Chiesi Clinical Trial - Site 840704
  - Cypress, Texas, United States, 77429-4696
    - Chiesi Clinical Trial - Site 840566
  - Dallas, Texas, United States, 75246
    - Chiesi Clinical Trial - Site 840706
  - Houston, Texas, United States, 77008
    - Chiesi Clinical Trial - Site 840716
  - Houston, Texas, United States, 77030
    - Chiesi Clinical Trial - Site 840698
  - Kerrville, Texas, United States, 78028-9640
    - Chiesi Clinical Trial - Site 840574
  - McKinney, Texas, United States, 75069
    - Chiesi Clinical Trial - Site 840551
  - Mesquite, Texas, United States, 75149-2438
    - Chiesi Clinical Trial - Site 840575
  - North Richland Hills, Texas, United States, 76180-7319
    - Chiesi Clinical Trial - Site 840741
  - Pearland, Texas, United States, 77584-7401
    - Chiesi Clinical Trial - Site 840663
  - Plano, Texas, United States, 75025
    - Chiesi Clinical Trial - Site 840609
  - San Antonio, Texas, United States, 78215-1528
    - Chiesi Clinical Trial - Site 840673
  - San Antonio, Texas, United States, 78229
    - Chiesi Clinical Trial - Site 840681
  - San Antonio, Texas, United States, 78229
    - Chiesi Clinical Trial - Site 840711
  - San Antonio, Texas, United States, 78229
    - Chiesi Clinical Trial - Site 840729
  - San Antonio, Texas, United States, 78258
    - Chiesi Clinical Trial - Site 840597
  - Sherman, Texas, United States, 75092-7351
    - Chiesi Clinical Trial - Site 840600
  - Sugar Land, Texas, United States, 77479-3481
    - Chiesi Clinical Trial - Site 840552
  - Tomball, Texas, United States, 77373
    - Chiesi Clinical Trial - Site 840526
- Virginia
  - Portsmouth, Virginia, United States, 23703
    - Chiesi Clinical Trial - Site 840693
- Washington
  - Everett, Washington, United States, 98208
    - Chiesi Clinical Trial - Site 840709
- West Virginia
  - Morgantown, West Virginia, United States, 26505-0423
    - Chiesi Clinical Trial - Site 840562
- Wisconsin
  - Greenfield, Wisconsin, United States, 53228-3467
    - Chiesi Clinical Trial - Site 840532

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 with chronic bronchitis.
Current smokers or ex-smokers (history of ≥10 pack years).
Post-bronchodilator FEV1 <50% of the patient predicted normal value and FEV1/FVC ratio < 0.7.
At least, one moderate or severe COPD exacerbation in the 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 before study entry and randomisation
Subjects with known α-1 antitrypsin deficiency as the underlying cause of COPD.
Subjects with primary diagnosis of emphysema not related to COPD.
Subjects with known respiratory disorders other than COPD.
Subjects with lung volume reduction surgery.
Subjects with active cancer or a history of lung cancer.
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 condition.
Subjects with 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
Placebo Comparator: Placebo	Drug: Placebo CHF6001 matching placebo, 2 inhalations bid and Roflumilast matching placebo, 1 tablet once daily
Experimental: CHF6001 1600µg	Drug: CHF6001 1600µg CHF6001 400µg, 2 inhalations bid (total daily dose of 1600µg) and Roflumilast matching placebo, 1 tablet once daily
Experimental: CHF6001 3200µg	Drug: CHF6001 3200µg CHF6001 800µg, 2 inhalations bid (total daily dose of 3200µg) and Roflumilast matching placebo, 1 tablet once daily
Active Comparator: Roflumilast	Drug: Roflumilast - 1 tablet of Roflumilast (Daliresp®), 250µg, once daily during the first 4 weeks of treatment then 1 tablet of Roflumilast (Daliresp®), 500µg, once daily for the remaining treatment period and 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 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 corticosteroids (oral/IV/IM corticosteroids), and/or use of antibiotics Severe : requiring hospitalisation or resulting in death	Up to 52 weeks

Secondary Outcome Measures

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: Fernando J. MARTINEZ, Prof., Weill Cornell Medical College, New York Presbyterian Hospital, 1305 York avenue box 96 NY 10021 USA

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 12, 2021

Primary Completion (Actual)

December 23, 2025

Study Completion (Actual)

December 23, 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 (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CLI-06001AA1-05
2020-003648-97 (EudraCT Number)
2023-510174-13-00 (Ctis)

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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Outcome Measure	Measure Description	Time Frame
The time to first moderate or severe exacerbation. Time Frame: Up to 52 weeks	The time to first moderate or severe exacerbation.	Up to 52 weeks
The annual rate of severe exacerbations. Time Frame: Up to 52 weeks	The annual rate of severe exacerbations.	Up to 52 weeks
The time to first severe exacerbation. Time Frame: Up to 52 weeks	The time to first severe exacerbation.	Up to 52 weeks
The number of all on-treatment severe exacerbations. Time Frame: Up to 52 weeks	The number of all on-treatment severe exacerbations.	Up to 52 weeks
The number of all on-treatment exacerbations requiring systemic corticosteroids. Time Frame: Up to 52 weeks	The number of all on-treatment exacerbations requiring systemic corticosteroids.	Up to 52 weeks
Change from baseline (pre-dose Visit 2) in pre-dose FEV1, at week 52. Time Frame: At week 52	Change from baseline (pre-dose Visit 2) in pre-dose FEV1, at week 52.	At week 52
Change from baseline in Saint Georges Respiratory Questionnaire (SGRQ) total and domain scores at week 52. Time Frame: At week 52	Change from baseline in Saint Georges Respiratory Questionnaire (SGRQ) total and domain scores at week 52.	At week 52
Saint Georges Respiratory Questionnaire response (SGRQ) (change from baseline SGRQ total score ≤ -4) at week 52. Time Frame: At week 52	Saint Georges Respiratory Questionnaire response (SGRQ) (change from baseline SGRQ total score ≤ -4) at week 52.	At week 52
Change from baseline to last inter-visit period (week 40-52) in EXACT-Respiratory Symptoms (E-RS) Total and subscale scores. Time Frame: Up to 52 weeks	Change from baseline to last inter-visit period (week 40-52) in EXACT-Respiratory Symptoms (E-RS) Total and subscale scores.	Up to 52 weeks
E-RS response (change from baseline E-RS Total score ≤ -2) at week 52. Time Frame: At week 52	E-RS response (change from baseline E-RS Total score ≤ -2) 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	Change from baseline to last inter-visit period (week 40-52) in the percentage of days	Up to 52 weeks
Time to study medication discontinuation for any reason. Time Frame: Up to 52 weeks	Time to study medication discontinuation for any reason.	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	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.	Up to 52 weeks
Time to first moderate/severe exacerbation or study medication discontinuation due to any class-related AE, lack of efficacy, or death (composite endpoint) and time to study medication discontinuation component. Time Frame: Up to 52 weeks	Time to first moderate/severe exacerbation or study medication discontinuation due to any class-related AE, lack of efficacy, or death (composite endpoint) and time to study medication discontinuation component.	Up to 52 weeks
Key Secondary Variable: Change from baseline in SGRQ Total score at week 52 Time Frame: At week 52	Key Secondary Variable: Change from baseline in SGRQ Total score at week 52	At week 52

A 52-week, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg) Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI (Tanimilast) as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis. (PILLAR) (PILLAR)

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

Measure Description

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 (Actual)

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)?

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Clinical Trials on CHF6001 1600µg

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