Chronic Obstructive Pulmonary Disease Clinical Trial
— PILLAROfficial title:
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.
| Status | Recruiting |
| Enrollment | 3980 |
| Est. completion date | September 18, 2027 |
| Est. primary completion date | September 11, 2027 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years and older |
| Eligibility | 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 a-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. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Chiesi Clinical Trial - Site 32502 | Buenos Aires | |
| Argentina | Chiesi Clinical Trial - Site 32515 | Buenos Aires | |
| Argentina | Chiesi Clinical Trial - Site 32565 | Buenos Aires | |
| Argentina | Chiesi Clinical Trial - Site 32514 | Ciudad Autonoma Buenos Aires | |
| Argentina | Chiesi Clinical Trial - Site 32567 | Ciudad Autonoma Buenos Aires | |
| Argentina | Chiesi Clinical Trial - Site 32507 | Ciudad Autónoma de Buenos Aire | |
| Argentina | Chiesi Clinical Trial - Site 32510 | Ciudad autónoma de Buenos Aires | |
| Argentina | Chiesi Clinical Trial - Site 32503 | Córdoba | |
| Argentina | Chiesi Clinical Trial - Site 32509 | Córdoba | |
| Argentina | Chiesi Clinical Trial - Site 32508 | Florencio Varela | |
| Argentina | Chiesi Clinical Trial - Site 32501 | Florida | |
| Argentina | Chiesi Clinical Trial - Site 32562 | Mar Del Plata | |
| Argentina | Chiesi Clinical Trial - Site 32505 | Mendoza | |
| Argentina | Chiesi Clinical Trial - Site 32511 | Mendoza | |
| Argentina | Chiesi Clinical Trial - Site 32513 | Mendoza | |
| Argentina | Chiesi Clinical Trial - Site 32506 | Quilmes | |
| Argentina | Chiesi Clinical Trial - Site 32553 | Rosario | |
| 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 Miguel De Tucumán | |
| Argentina | Chiesi Clinical Trial - Site 32566 | San Rafael | |
| Argentina | Chiesi Clinical Trial - Site 32556 | Santa Fe | |
| Austria | Chiesi Clinical Trial - Site 40502 | Feldbach | |
| Austria | Chiesi Clinical Trial - Site 40504 | Grieskirchen | |
| Austria | Chiesi Clinical Trial - Site 40501 | Linz | |
| Austria | Chiesi Clinical Trial - Site 40503 | Linz | |
| Austria | Chiesi Clinical Trial - Site 40505 | Wels | |
| Bosnia and Herzegovina | Chiesi Clinical Trial - Site 70553 | Banja Luka | |
| Bosnia and Herzegovina | Chiesi Clinical Trial - Site 70555 | Bihac | |
| Bosnia and Herzegovina | Chiesi Clinical Trial - Site 70554 | Bijeljina | |
| Bosnia and Herzegovina | Chiesi Clinical Trial - Site 70557 | Foca | |
| Bosnia and Herzegovina | Chiesi Clinical Trial - Site 70556 | Gradiška | |
| Bosnia and Herzegovina | Chiesi Clinical Trial - Site 70560 | Mostar | |
| Bosnia and Herzegovina | Chiesi Clinical Trial - Site 70562 | Mostar | |
| Bosnia and Herzegovina | Chiesi Clinical Trial - Site 70559 | Sarajevo | |
| Bosnia and Herzegovina | Chiesi Clinical Trial - Site 70561 | Sarajevo | |
| Bosnia and Herzegovina | Chiesi Clinical Trial - Site 70551 | Travnik | |
| Bosnia and Herzegovina | Chiesi Clinical Trial - Site 70558 | Trebinje | |
| Bosnia and Herzegovina | Chiesi Clinical Trial - Site 70563 | Tuzla | |
| Bosnia and Herzegovina | Chiesi Clinical Trial - Site 70552 | Zenica | |
| Bulgaria | Chiesi Clinical Trial - Site 100535 | Blagoevgrad | |
| Bulgaria | Chiesi Clinical Trial - Site 100534 | Dimitrovgrad | |
| Bulgaria | Chiesi Clinical Trial - Site 100525 | Gabrovo | |
| Bulgaria | Chiesi Clinical Trial - Site 100523 | Haskovo | |
| Bulgaria | Chiesi Clinical Trial - Site 100533 | Kozloduy | |
| Bulgaria | Chiesi Clinical Trial - Site 100527 | Lovech | |
| Bulgaria | Chiesi Clinical Trial - Site 100515 | Montana | |
| Bulgaria | Chiesi Clinical Trial - Site 100532 | Pernik | |
| Bulgaria | Chiesi Clinical Trial - Site 100522 | Pleven | |
| Bulgaria | Chiesi Clinical Trial - Site 100529 | Plovdiv | |
| Bulgaria | Chiesi Clinical Trial - Site 100537 | Razgrad | |
| Bulgaria | Chiesi Clinical Trial - Site 100512 | Ruse | |
| Bulgaria | Chiesi Clinical Trial - Site 100516 | Ruse | |
| Bulgaria | Chiesi Clinical Trial - Site 100536 | Sevlievo | |
| 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 | Sofia | |
| Bulgaria | Chiesi Clinical Trial - Site 100524 | Stara Zagora | |
| Bulgaria | Chiesi Clinical Trial - Site 100519 | Vidin | |
| Bulgaria | Chiesi Clinical Trial - Site 100557 | Vidin | |
| Chile | Chiesi Clinical Trial - Site 152506 | Concepcion | |
| Chile | Chiesi Clinical Trial - Site 152507 | Quillota | |
| Chile | Chiesi Clinical Trial - Site 152503 | Santiago | |
| Chile | Chiesi Clinical Trial - Site 152504 | Santiago | |
| Chile | Chiesi Clinical Trial - Site 152508 | Santiago | |
| Chile | Chiesi Clinical Trial - Site 152509 | Talca | |
| Chile | Chiesi Clinical Trial - Site 152501 | Valparaiso | |
| Croatia | Chiesi Clinical Trial - Site 191562 | Dubrovnik | |
| Croatia | Chiesi Clinical Trial - Site 191552 | Karlovac | |
| Croatia | Chiesi Clinical Trial - Site 191557 | Osijek | |
| Croatia | Chiesi Clinical Trial - Site 191561 | Rijeka | |
| Croatia | Chiesi Clinical Trial - Site 191563 | Rijeka | |
| Croatia | Chiesi Clinical Trial - Site 191553 | Sisak | |
| Croatia | Chiesi Clinical Trial - Site 191558 | Split | |
| Croatia | Chiesi Clinical Trial - Site 191555 | Zadar | |
| 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 | Zagreb | |
| Czechia | Chiesi Clinical Trial - Site 203551 | Brandýs Nad Labem | |
| Czechia | Chiesi Clinical Trial - Site 203518 | Havlíckuv Brod | |
| Czechia | Chiesi Clinical Trial - Site 203501 | Jindrichuv Hradec | |
| Czechia | Chiesi Clinical Trial - Site 203517 | Mešice | |
| Czechia | Chiesi Clinical Trial - Site 203504 | Miroslav | |
| Czechia | Chiesi Clinical Trial - Site 203516 | Mladá Boleslav | |
| Czechia | Chiesi Clinical Trial - Site 203505 | Praha | |
| Czechia | Chiesi Clinical Trial - Site 203507 | Praha | |
| Czechia | Chiesi Clinical Trial - Site 203513 | Praha | |
| Czechia | Chiesi Clinical Trial - Site 203515 | Praha | |
| Estonia | Chiesi Clinical Trial - Site 372553 | Narva | |
| Estonia | Chiesi Clinical Trial - Site 372551 | Tallinn | |
| Estonia | Chiesi Clinical Trial - Site 372552 | Tartu | |
| 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 | Berlin | |
| Germany | Chiesi Clinical Trial - Site 276556 | Cottbus | |
| Germany | Chiesi Clinical Trial - Site 276509 | Darmstadt | |
| Germany | Chiesi Clinical Trial - Site 276503 | Delitzsch | |
| Germany | Chiesi Clinical Trial - Site 276504 | Frankfurt Am Main | |
| Germany | Chiesi Clinical Trial - Site 276557 | Geesthacht | |
| Germany | Chiesi Clinical Trial - Site 276501 | Hamburg | |
| Germany | Chiesi Clinical Trial - Site 276513 | Hamburg | |
| Germany | Chiesi Clinical Trial - Site 276514 | Hamburg | |
| Germany | Chiesi Clinical Trial - Site 276558 | Hannover | |
| Germany | Chiesi Clinical Trial - Site 276517 | Koblenz | |
| Germany | Chiesi Clinical Trial - Site 276502 | Leipzig | |
| Germany | Chiesi Clinical Trial - Site 276516 | Leipzig | |
| Germany | Chiesi Clinical Trial - Site 276551 | Leipzig | |
| Germany | Chiesi Clinical Trial - Site 276507 | Mainz | |
| Germany | Chiesi Clinical Trial - Site 276508 | Munich | |
| Germany | Chiesi Clinical Trial - Site 276518 | Peine | |
| Greece | Chiesi Clinical Trial - Site 300506 | Athens | |
| Greece | Chiesi Clinical Trial - Site 300504 | Chortiátis | |
| Greece | Chiesi Clinical Trial - Site 300501 | Heraklion | |
| Greece | Chiesi Clinical Trial - Site 300503 | Ioannina | |
| Greece | Chiesi Clinical Trial - Site 300505 | Thessaloníki | |
| Greece | Chiesi Clinical Trial - Site 300507 | Volos | |
| Hungary | Chiesi Clinical Trial - Site 348506 | Balassagyarmat | |
| Hungary | Chiesi Clinical Trial - Site 348501 | Budapest | |
| Hungary | Chiesi Clinical Trial - Site 348505 | Csorna | |
| Hungary | Chiesi Clinical Trial - Site 348512 | Edelény | |
| Hungary | Chiesi Clinical Trial - Site 348508 | Gödöllo | |
| Hungary | Chiesi Clinical Trial - Site 348509 | Monor | |
| Hungary | Chiesi Clinical Trial - Site 348507 | Nyíregyháza | |
| Hungary | Chiesi Clinical Trial - Site 348513 | Pécs | |
| Hungary | Chiesi Clinical Trial - Site 348552 | Sellye | |
| Hungary | Chiesi Clinical Trial - Site 348510 | Szeged | |
| Hungary | Chiesi Clinical Trial - Site 348503 | Szombathely | |
| Hungary | Chiesi Clinical Trial - Site 348515 | Törökbálint | |
| Israel | Chiesi Clinical Trial - Site 376502 | Ashkelon | |
| Israel | Chiesi Clinical Trial - Site 376501 | Be'er Sheva | |
| Israel | Chiesi Clinical Trial - Site 376511 | Hadera | |
| Israel | Chiesi Clinical Trial - Site 376508 | Haifa | |
| Israel | Chiesi Clinical Trial - Site 376510 | Haifa | |
| Israel | Chiesi Clinical Trial - Site 376503 | Jerusalem | |
| Israel | Chiesi Clinical Trial - Site 376506 | Jerusalem | |
| Israel | Chiesi Clinical Trial - Site 376507 | Kfar Saba | |
| Israel | Chiesi Clinical Trial - Site 376504 | Ramat Gan | |
| Israel | Chiesi Clinical Trial - Site 376509 | Tel Aviv | |
| Korea, Republic of | Chiesi Clinical Trial - Site 408556 | Anyang-si | |
| Korea, Republic of | Chiesi Clinical Trial - Site 408551 | Daegu | |
| Korea, Republic of | Chiesi Clinical Trial - Site 408560 | Dongjak | |
| Korea, Republic of | Chiesi Clinical Trial - Site 408554 | Gwangju | |
| Korea, Republic of | Chiesi Clinical Trial - Site 408559 | Haeundae | |
| Korea, Republic of | Chiesi Clinical Trial - Site 408557 | Incheon | |
| Korea, Republic of | Chiesi Clinical Trial - Site 408558 | Incheon | |
| Korea, Republic of | Chiesi Clinical Trial - Site 408555 | Jeonju | |
| Korea, Republic of | Chiesi Clinical Trial - Site 408552 | Seoul | |
| Korea, Republic of | Chiesi Clinical Trial - Site 408553 | Seoul | |
| Korea, Republic of | Chiesi Clinical Trial - Site 408561 | Suwon,Gyeonggi-do | |
| Latvia | Chiesi Clinical Trial - Site 371557 | Balvi | |
| Latvia | Chiesi Clinical Trial - Site 371553 | Daugavpils | |
| Latvia | Chiesi Clinical Trial - Site 371554 | Daugavpils | |
| Latvia | Chiesi Clinical Trial - Site 371555 | Jurmala | |
| Latvia | Chiesi Clinical Trial - Site 371558 | Rezekne | |
| Latvia | Chiesi Clinical Trial - Site 371551 | Riga | |
| Latvia | Chiesi Clinical Trial - Site 371552 | Riga | |
| Latvia | Chiesi Clinical Trial - Site 371556 | Riga | |
| Mexico | Chiesi Clinical Trial - Site 484502 | Chihuahua | |
| Mexico | Chiesi Clinical Trial - Site 484510 | Chihuahua | |
| Mexico | Chiesi Clinical Trial - Site 484505 | Cordoba | |
| Mexico | Chiesi Clinical Trial - Site 484506 | Cuauhtémoc | |
| Mexico | Chiesi Clinical Trial - Site 484501 | Guadalajara | |
| Mexico | Chiesi Clinical Trial - Site 484507 | Guadalajara | |
| Mexico | Chiesi Clinical Trial - Site 484509 | Guadalajara | |
| Mexico | Chiesi Clinical Trial - Site 484503 | Monterrey | |
| Mexico | Chiesi Clinical Trial - Site 484511 | Monterrey | |
| Mexico | Chiesi Clinical Trial - Site 484504 | Veracruz | |
| Netherlands | Chiesi Clinical Trial - Site 528501 | Beek | |
| Netherlands | Chiesi Clinical Trial - Site 528504 | Breda | |
| Netherlands | Chiesi Clinical Trial - Site 528502 | Heerlen | |
| Netherlands | Chiesi Clinical Trial - Site 528505 | Leeuwarden | |
| New Zealand | Chiesi Clinical Trial - Site 554504 | Christchurch | |
| New Zealand | Chiesi Clinical Trial - Site 554502 | Hamilton | |
| New Zealand | Chiesi Clinical Trial - Site 554503 | Tauranga | |
| North Macedonia | Chiesi Clinical Trial - Site 807555 | Bitola | |
| North Macedonia | Chiesi Clinical Trial - Site 807559 | Gevgelija | |
| North Macedonia | Chiesi Clinical Trial - Site 807557 | Ohrid | |
| North Macedonia | Chiesi Clinical Trial - Site 807553 | Shtip | |
| North Macedonia | Chiesi Clinical Trial - Site 807552 | Skopje | |
| North Macedonia | Chiesi Clinical Trial - Site 807554 | Skopje | |
| North Macedonia | Chiesi Clinical Trial - Site 807556 | Skopje | |
| Poland | Chiesi Clinical Trial - Site 616518 | Bialystok | |
| Poland | Chiesi Clinical Trial - Site 616504 | Gizycko | |
| Poland | Chiesi Clinical Trial - Site 616515 | Katowice | |
| Poland | Chiesi Clinical Trial - Site 616522 | Katowice | |
| Poland | Chiesi Clinical Trial - Site 616514 | Krakow | |
| Poland | Chiesi Clinical Trial - Site 616509 | Kraków | |
| Poland | Chiesi Clinical Trial - Site 616511 | Kraków | |
| Poland | Chiesi Clinical Trial - Site 616503 | Lódz | |
| Poland | Chiesi Clinical Trial - Site 616523 | Lódz | |
| Poland | Chiesi Clinical Trial - Site 616519 | Ostrowiec Swietokrzyski | |
| Poland | Chiesi Clinical Trial - Site 616506 | Poznan | |
| Poland | Chiesi Clinical Trial - Site 616508 | Poznan | |
| Poland | Chiesi Clinical Trial - Site 616501 | Sosnowiec | |
| Poland | Chiesi Clinical Trial - Site 616502 | Torun | |
| Poland | Chiesi Clinical Trial - Site 616554 | Wroclaw | |
| Romania | Chiesi Clinical Trial - Site 642510 | Bacau | |
| Romania | Chiesi Clinical Trial - Site 642551 | Brasov | |
| Romania | Chiesi Clinical Trial - Site 642512 | Cluj | |
| Romania | Chiesi Clinical Trial - Site 642502 | Cluj-Napoca | |
| Romania | Chiesi Clinical Trial - Site 642504 | Cluj-Napoca | |
| Romania | Chiesi Clinical Trial - Site 642554 | Cluj-Napoca | |
| Romania | Chiesi Clinical Trial - Site 642506 | Cluj-Napoca Cluj | |
| Romania | Chiesi Clinical Trial - Site 642508 | Cluj-Napoca Cluj | |
| Romania | Chiesi Clinical Trial - Site 642501 | Constanta | |
| Romania | Chiesi Clinical Trial - Site 642509 | Craiova | |
| Romania | Chiesi Clinical Trial - Site 642511 | Craiova | |
| Romania | Chiesi Clinical Trial - Site 642514 | Iasi | |
| Romania | Chiesi Clinical Trial - Site 642503 | Oradea | |
| Romania | Chiesi Clinical Trial - Site 642513 | Resca | |
| Romania | Chiesi Clinical Trial - Site 642505 | Timisoara | |
| Romania | Chiesi Clinical Trial - Site 642507 | Timisoara | |
| Romania | Chiesi Clinical Trial - Site 642515 | Timisoara | |
| Russian Federation | Chiesi Clinical Trial - Site 643517 | Kazan | |
| Russian Federation | Chiesi Clinical Trial - Site 643513 | Moscow | |
| Russian Federation | Chiesi Clinical Trial - Site 643528 | Moscow | |
| Russian Federation | Chiesi Clinical Trial - Site 643516 | Nizhniy Novgorod | |
| Russian Federation | Chiesi Clinical Trial - Site 643503 | Odintsovskiy | |
| Russian Federation | Chiesi Clinical Trial - Site 643505 | Saint Petersburg | |
| Russian Federation | Chiesi Clinical Trial - Site 643506 | Saint Petersburg | |
| Russian Federation | Chiesi Clinical Trial - Site 643508 | Saint Petersburg | |
| Russian Federation | Chiesi Clinical Trial - Site 643511 | Saint Petersburg | |
| Russian Federation | Chiesi Clinical Trial - Site 643514 | Saint Petersburg | |
| Russian Federation | Chiesi Clinical Trial - Site 643519 | Saint Petersburg | |
| Russian Federation | Chiesi Clinical Trial - Site 643531 | Saint Petersburg | |
| Russian Federation | Chiesi Clinical Trial - Site 643510 | Saint-Petersburg | |
| Russian Federation | Chiesi Clinical Trial - Site 643512 | Saint-Petersburg | |
| Russian Federation | Chiesi Clinical Trial - Site 643520 | Saint-Petersburg | |
| Russian Federation | Chiesi Clinical Trial - Site 643504 | Sankt-Peterburg | |
| Russian Federation | Chiesi Clinical Trial - Site 643515 | Saratov | |
| Russian Federation | Chiesi Clinical Trial - Site 643525 | Saratov | |
| Russian Federation | Chiesi Clinical Trial - Site 643521 | Ulyanovsk | |
| Russian Federation | Chiesi Clinical Trial - Site 643502 | Voronezh | |
| Russian Federation | Chiesi Clinical Trial - Site 643524 | Vsevolozhsk | |
| Russian Federation | Chiesi Clinical Trial - Site 643507 | Yaroslavl | |
| Russian Federation | Chiesi Clinical Trial - Site 643518 | Yaroslavl | |
| 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 | Belgrade | |
| Serbia | Chiesi Clinical Trial - Site 688570 | Jagodina | |
| Serbia | Chiesi Clinical Trial - Site 688556 | Kragujevac | |
| Serbia | Chiesi Clinical Trial - Site 688562 | Leskovac | |
| Serbia | Chiesi Clinical Trial - Site 688554 | Niš | |
| Serbia | Chiesi Clinical Trial - Site 688568 | Niš | |
| Serbia | Chiesi Clinical Trial - Site 688567 | Pancevo | |
| Serbia | Chiesi Clinical Trial - Site 688560 | Paracin | |
| Serbia | Chiesi Clinical Trial - Site 688551 | Sombor | |
| Serbia | Chiesi Clinical Trial - Site 688564 | Sremska Kamenica | |
| Serbia | Chiesi Clinical Trial - Site 688566 | Sremska Kamenica | |
| Serbia | Chiesi Clinical Trial - Site 688571 | Sremska Mitrovica | |
| Serbia | Chiesi Clinical Trial - Site 688563 | Užice | |
| Serbia | Chiesi Clinical Trial - Site 688565 | Valjevo | |
| Slovakia | Chiesi Clinical Trial - Site 703501 | Bardejov | |
| Slovakia | Chiesi Clinical Trial - Site 703503 | Košice | |
| Slovakia | Chiesi Clinical Trial - Site 703502 | Spišská Nová Ves | |
| Spain | Chiesi Clinical Trial - Site 724503 | Barcelona | |
| Spain | Chiesi Clinical Trial - Site 724501 | Cordoba | |
| Spain | Chiesi Clinical Trial - Site 724505 | Madrid | |
| Spain | Chiesi Clinical Trial - Site 724551 | Madrid | |
| Spain | Chiesi Clinical Trial - Site 724504 | Majadahonda | |
| Spain | Chiesi Clinical Trial - Site 724502 | Zaragoza | |
| Turkey | Chiesi Clinical Trial - Site 792512 | Adana | |
| Turkey | Chiesi Clinical Trial - Site 792510 | Bornova | |
| Turkey | Chiesi Clinical Trial - Site 792551 | Çanakkale | |
| Turkey | Chiesi Clinical Trial - Site 792507 | Istanbul | |
| Turkey | Chiesi Clinical Trial - Site 792514 | Kocaeli | |
| Turkey | Chiesi Clinical Trial - Site 792513 | Mersin | |
| Turkey | Chiesi Clinical Trial - Site 792506 | Pamukkale | |
| Turkey | Chiesi Clinical Trial - Site 792508 | Pendik | |
| Turkey | Chiesi Clinical Trial - Site 792511 | Yenisehir | |
| Ukraine | Chiesi Clinical Trial - Site 804522 | Dnipro | |
| Ukraine | Chiesi Clinical Trial - Site 804502 | Ivano-Frankivs'k | |
| Ukraine | Chiesi Clinical Trial - Site 804504 | Kharkiv | |
| Ukraine | Chiesi Clinical Trial - Site 804506 | Kharkiv | |
| Ukraine | Chiesi Clinical Trial - Site 804509 | Kharkiv | |
| Ukraine | Chiesi Clinical Trial - Site 804505 | Kharkov | |
| Ukraine | Chiesi Clinical Trial - Site 804503 | Kherson | |
| Ukraine | Chiesi Clinical Trial - Site 804511 | Kiev | |
| Ukraine | Chiesi Clinical Trial - Site 804520 | Kremenchuk | |
| 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 | Kyiv | |
| Ukraine | Chiesi Clinical Trial - Site 804527 | Odessa | |
| Ukraine | Chiesi Clinical Trial - Site 804507 | Poltava | |
| Ukraine | Chiesi Clinical Trial - Site 804515 | Vinnytsia | |
| Ukraine | Chiesi Clinical Trial - Site 804517 | Vinnytsia | |
| Ukraine | Chiesi Clinical Trial - Site 804528 | Zaporizhia | |
| United Kingdom | Chiesi Clinical Trial - Site 826510 | Belfast | |
| United Kingdom | Chiesi Clinical Trial - Site 826509 | Bradford | |
| United Kingdom | Chiesi Clinical Trial - Site 826511 | London | |
| United Kingdom | Chiesi Clinical Trial - Site 826512 | Rochdale | |
| United States | Chiesi Clinical Trial - Site 840542 | Adairsville | Georgia |
| United States | Chiesi Clinical Trial - Site 840635 | Andalusia | Alabama |
| United States | Chiesi Clinical Trial - Site 840578 | Anderson | South Carolina |
| United States | Chiesi Clinical Trial - Site 840645 | Annapolis | Maryland |
| United States | Chiesi Clinical Trial - Site 840661 | Baltimore | Maryland |
| United States | Chiesi Clinical Trial - Site 840535 | Baytown | Texas |
| United States | Chiesi Clinical Trial - Site 840634 | Boerne | Texas |
| United States | Chiesi Clinical Trial - Site 840604 | Bronx | New York |
| United States | Chiesi Clinical Trial - Site 840626 | Bronx | New York |
| United States | Chiesi Clinical Trial - Site 840667 | Buffalo | New York |
| United States | Chiesi Clinical Trial - Site 840704 | Carrollton | Texas |
| United States | Chiesi Clinical Trial - Site 840636 | Centennial | Colorado |
| United States | Chiesi Clinical Trial - Site 840592 | Charleston | South Carolina |
| United States | Chiesi Clinical Trial - Site 840664 | Charlotte | North Carolina |
| United States | Chiesi Clinical Trial - Site 840513 | Chiefland | Florida |
| United States | Chiesi Clinical Trial - Site 840627 | Cincinnati | Ohio |
| United States | Chiesi Clinical Trial - Site 840569 | Clearwater | Florida |
| United States | Chiesi Clinical Trial - Site 840652 | Clearwater | Florida |
| United States | Chiesi Clinical Trial - Site 840684 | Conway | Arkansas |
| United States | Chiesi Clinical Trial - Site 840545 | Coral Gables | Florida |
| United States | Chiesi Clinical Trial - Site 840568 | Cutler Bay | Florida |
| United States | Chiesi Clinical Trial - Site 840587 | Cutler Bay | Florida |
| United States | Chiesi Clinical Trial - Site 840603 | Cutler Bay | Florida |
| United States | Chiesi Clinical Trial - Site 840566 | Cypress | Texas |
| United States | Chiesi Clinical Trial - Site 840647 | Dayton | Ohio |
| United States | Chiesi Clinical Trial - Site840539 | Daytona Beach | Florida |
| United States | Chiesi Clinical Trial - Site 840554 | DeBary | Florida |
| United States | Chiesi Clinical Trial - Site 840610 | Denver | North Carolina |
| United States | Chiesi Clinical Trial - Site 840572 | Doral | Florida |
| United States | Chiesi Clinical Trial - Site 840625 | Doral | Florida |
| United States | Chiesi Clinical Trial - Site 840689 | East Point | Georgia |
| United States | Chiesi Clinical Trial - Site 840687 | Flint | Michigan |
| United States | Chiesi Clinical Trial - Site 840614 | Foley | Alabama |
| United States | Chiesi Clinical Trial - Site 840528 | Fort Mill | South Carolina |
| United States | Chiesi Clinical Trial - Site 840546 | Franklin | Tennessee |
| United States | Chiesi Clinical Trial - Site 840660 | Franklin | Tennessee |
| United States | Chiesi Clinical Trial - Site 840659 | Gastonia | North Carolina |
| United States | Chiesi Clinical Trial - Site 840532 | Greenfield | Wisconsin |
| United States | Chiesi Clinical Trial - Site 840670 | Guntersville | Alabama |
| United States | Chiesi Clinical Trial - Site 840703 | Henderson | Nevada |
| United States | Chiesi Clinical Trial - Site 840504 | Hialeah | Florida |
| United States | Chiesi Clinical Trial - Site 840514 | Hialeah | Florida |
| United States | Chiesi Clinical Trial - Site 840582 | Hialeah | Florida |
| United States | Chiesi Clinical Trial - Site 840617 | Hialeah | Florida |
| United States | Chiesi Clinical Trial - Site 840639 | Hialeah | Florida |
| United States | Chiesi Clinical Trial - Site 840685 | Hialeah | Florida |
| United States | Chiesi Clinical Trial - Site 840637 | Hialeah Gardens | Florida |
| United States | Chiesi Clinical Trial - Site 840509 | Hollywood | Florida |
| United States | Chiesi Clinical Trial - Site 840565 | Homestead | Florida |
| United States | Chiesi Clinical Trial - Site 840540 | Huntersville | North Carolina |
| United States | Chiesi Clinical Trial - Site 840574 | Kerrville | Texas |
| United States | Chiesi Clinical Trial - Site 840553 | Knoxville | Tennessee |
| United States | Chiesi Clinical Trial - Site 840675 | Laguna Hills | California |
| United States | Chiesi Clinical Trial - Site 840688 | Lakewood | Colorado |
| United States | Chiesi Clinical Trial - Site 840529 | Las Vegas | Nevada |
| United States | Chiesi Clinical Trial - Site 840666 | Los Angeles | California |
| United States | Chiesi Clinical Trial - Site 840674 | Loxahatchee Groves | Florida |
| United States | Chiesi Clinical Trial - Site 840551 | McKinney | Texas |
| United States | Chiesi Clinical Trial - Site 840575 | Mesquite | Texas |
| United States | Chiesi Clinical Trial - Site 840503 | Miami | Florida |
| United States | Chiesi Clinical Trial - Site 840505 | Miami | Florida |
| United States | Chiesi Clinical Trial - Site 840507 | Miami | Florida |
| United States | Chiesi Clinical Trial - Site 840519 | Miami | Florida |
| United States | Chiesi Clinical Trial - Site 840525 | Miami | Florida |
| United States | Chiesi Clinical Trial - Site 840537 | Miami | Florida |
| United States | Chiesi Clinical Trial - Site 840556 | Miami | Florida |
| United States | Chiesi Clinical Trial - Site 840557 | Miami | Florida |
| United States | Chiesi Clinical Trial - Site 840588 | Miami | Florida |
| United States | Chiesi Clinical Trial - Site 840596 | Miami | Florida |
| United States | Chiesi Clinical Trial - Site 840602 | Miami | Florida |
| United States | Chiesi Clinical Trial - Site 840618 | Miami | Florida |
| United States | Chiesi Clinical Trial - Site 840622 | Miami | Florida |
| United States | Chiesi Clinical Trial - Site 840624 | Miami | Florida |
| United States | Chiesi Clinical Trial - Site 840630 | Miami | Florida |
| United States | Chiesi Clinical Trial - Site 840644 | Miami | Florida |
| United States | Chiesi Clinical Trial - Site 840656 | Miami | Florida |
| United States | Chiesi Clinical Trial - Site 840691 | Miami | Florida |
| United States | Chiesi Clinical Trial - Site 840694 | Miami | Florida |
| United States | Chiesi Clinical Trial - Site 840506 | Miami Gardens | Florida |
| United States | Chiesi Clinical Trial - Site 840608 | Miami Lakes | Florida |
| United States | Chiesi Clinical Trial - Site 840562 | Morgantown | West Virginia |
| United States | Chiesi Clinical Trial - Site 840523 | New Bern | North Carolina |
| United States | Chiesi Clinical Trial - Site 840678 | New Windsor | New York |
| United States | Chiesi Clinical Trial - Site 840520 | New York | New York |
| United States | Chiesi Clinical Trial - Site 840511 | Newport Beach | California |
| United States | Chiesi Clinical Trial - Site 840598 | North Charleston | South Carolina |
| United States | Chiesi Clinical Trial - Site 840701 | North Las Vegas | Nevada |
| United States | Chiesi Clinical Trial - Site 840605 | Northridge | California |
| United States | Chiesi Clinical Trial - Site 840680 | Northridge | California |
| United States | Chiesi Clinical Trial - Site 840668 | Oklahoma City | Oklahoma |
| United States | Chiesi Clinical Trial - Site 840686 | Omaha | Nebraska |
| United States | Chiesi Clinical Trial - Site 840524 | Orlando | Florida |
| United States | Chiesi Clinical Trial - Site 840563 | Orlando | Florida |
| United States | Chiesi Clinical Trial - Site 840663 | Pearland | Texas |
| United States | Chiesi Clinical Trial - Site 840502 | Pembroke Pines | Florida |
| United States | Chiesi Clinical Trial - Site 840550 | Pembroke Pines | Florida |
| United States | Chiesi Clinical Trial - Site 840702 | Pembroke Pines | Florida |
| United States | Chiesi Clinical Trial - Site 840671 | Philadelphia | Pennsylvania |
| United States | Chiesi Clinical Trial - Site 840683 | Philadelphia | Pennsylvania |
| United States | Chiesi Clinical Trial - Site 840638 | Phoenix | Arizona |
| United States | Chiesi Clinical Trial - Site 840609 | Plano | Texas |
| United States | Chiesi Clinical Trial - Site 840700 | Pomona | California |
| United States | Chiesi Clinical Trial - Site 840527 | Pompano Beach | Florida |
| United States | Chiesi Clinical Trial - Site 840658 | Port Gibson | Mississippi |
| United States | Chiesi Clinical Trial - Site 840693 | Portsmouth | Virginia |
| United States | Chiesi Clinical Trial - Site 840641 | Saint Charles | Missouri |
| United States | Chiesi Clinical Trial - Site 840541 | Saint Louis | Missouri |
| United States | Chiesi Clinical Trial - Site 840669 | Saint Louis | Missouri |
| United States | Chiesi Clinical Trial - Site 840697 | Saint Petersburg | Florida |
| United States | Chiesi Clinical Trial - Site 840597 | San Antonio | Texas |
| United States | Chiesi Clinical Trial - Site 840673 | San Antonio | Texas |
| United States | Chiesi Clinical Trial - Site 840681 | San Antonio | Texas |
| United States | Chiesi Clinical Trial - Site 840643 | Saraland | Alabama |
| United States | Chiesi Clinical Trial - Site 840600 | Sherman | Texas |
| United States | Chiesi Clinical Trial - Site 840654 | South Miami | Florida |
| United States | Chiesi Clinical Trial - Site 840552 | Sugar Land | Texas |
| United States | Chiesi Clinical Trial - Site 840567 | Tampa | Florida |
| United States | Chiesi Clinical Trial - Site 840646 | Toledo | Ohio |
| United States | Chiesi Clinical Trial - Site 840526 | Tomball | Texas |
| United States | Chiesi Clinical Trial - Site 840657 | Troy | Michigan |
| United States | Chiesi Clinical Trial - Site 840692 | Tulsa | Oklahoma |
| United States | Chiesi Clinical Trial - Site 840564 | Valdosta | Georgia |
| United States | Chiesi Clinical Trial - Site 840531 | Westminster | California |
| United States | Chiesi Clinical Trial - Site 840621 | Winston-Salem | North Carolina |
| United States | Chiesi Clinical Trial - Site 840632 | Winter Park | Florida |
| United States | Chiesi Clinical Trial - Site 840672 | Zachary | Louisiana |
| Lead Sponsor | Collaborator |
|---|---|
| Chiesi Farmaceutici S.p.A. |
United States, Argentina, Austria, Bosnia and Herzegovina, Bulgaria, Chile, Croatia, Czechia, Estonia, Germany, Greece, Hungary, Israel, Korea, Republic of, Latvia, Mexico, Netherlands, New Zealand, North Macedonia, Poland, Romania, Russian Federation, Serbia, Slovakia, Spain, Turkey, Ukraine, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The number of moderate and severe exacerbations occurring during the planned 52-week treatment period. | 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 | The time to first moderate or severe exacerbation. | The time to first moderate or severe exacerbation. | Up to 52 weeks | |
| Secondary | The annual rate of severe exacerbations. | The annual rate of severe exacerbations. | Up to 52 weeks | |
| Secondary | The time to first severe exacerbation. | The time to first severe exacerbation. | Up to 52 weeks | |
| Secondary | The number of all on-treatment severe exacerbations. | The number of all on-treatment severe exacerbations. | Up to 52 weeks | |
| Secondary | The number of all on-treatment exacerbations requiring systemic corticosteroids. | The number of all on-treatment exacerbations requiring systemic corticosteroids. | Up to 52 weeks | |
| Secondary | Change from baseline (pre-dose Visit 2) in pre-dose FEV1, at week 52. | Change from baseline (pre-dose Visit 2) in pre-dose FEV1, at week 52. | At week 52 | |
| Secondary | Change from baseline in Saint Georges Respiratory Questionnaire (SGRQ) total and domain scores at week 52. | Change from baseline in Saint Georges Respiratory Questionnaire (SGRQ) total and domain scores at week 52. | At week 52 | |
| Secondary | Saint Georges Respiratory Questionnaire response (SGRQ) (change from baseline SGRQ total score = -4) at week 52. | Saint Georges Respiratory Questionnaire response (SGRQ) (change from baseline SGRQ total score = -4) at week 52. | At week 52 | |
| Secondary | Change from baseline to last inter-visit period (week 40-52) in EXACT-Respiratory Symptoms (E-RS) Total and subscale scores. | 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 | |
| Secondary | E-RS response (change from baseline E-RS Total score = -2) at week 52. | E-RS response (change from baseline E-RS Total score = -2) at week 52. | At week 52 | |
| Secondary | 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). | Change from baseline to last inter-visit period (week 40-52) in the percentage of days | Up to 52 weeks | |
| Secondary | Time to study medication discontinuation for any reason. | Time to study medication discontinuation for any reason. | Up to 52 weeks | |
| Secondary | 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 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 | |
| Secondary | 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 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 | |
| Secondary | Key Secondary Variable: Change from baseline in SGRQ Total score at week 52 | Key Secondary Variable: Change from baseline in SGRQ Total score at week 52 | At week 52 |
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