Chronic Obstructive Pulmonary Disease Clinical Trial
— PILASTEROfficial title:
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.
| Status | Recruiting |
| Enrollment | 3435 |
| Est. completion date | June 20, 2025 |
| Est. primary completion date | June 13, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years and older |
| Eligibility | 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 a-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 |
| Country | Name | City | State |
|---|---|---|---|
| Albania | Chiesi Clinical Trial - Site 8455 | Durres | |
| Albania | Chiesi Clinical Trial - Site 8459 | Durres | |
| Albania | Chiesi Clinical Trial - Site 8457 | Elbasan | |
| Albania | Chiesi Clinical Trial - Site 8460 | Korca | |
| 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 | Tirana | |
| Argentina | Chiesi Clinical Trial - Site 32407 | Buenos Aires | |
| Argentina | Chiesi Clinical Trial - Site 32410 | Buenos Aires | |
| Argentina | Chiesi Clinical Trial - Site 32454 | Buenos Aires | |
| Argentina | Chiesi Clinical Trial - Site 32416 | Caba | |
| Argentina | Chiesi Clinical Trial - Site 32457 | Caba | |
| Argentina | Chiesi Clinical Trial - Site 32459 | Caba | |
| Argentina | Chiesi Clinical Trial - Site 32403 | Córdoba | |
| Argentina | Chiesi Clinical Trial - Site 32409 | Córdoba | |
| Argentina | Chiesi Clinical Trial - Site 32408 | Florencio Varela | |
| Argentina | Chiesi Clinical Trial - Site 32401 | Florida | |
| Argentina | Chiesi Clinical Trial - Site 32455 | La Plata | |
| Argentina | Chiesi Clinical Trial - Site 32417 | Mar Del Plata | |
| Argentina | Chiesi Clinical Trial - Site 32458 | Mar Del Plata | |
| Argentina | Chiesi Clinical Trial - Site 32462 | Mar Del Plata | |
| Argentina | Chiesi Clinical Trial - Site 32405 | Mendoza | |
| Argentina | Chiesi Clinical Trial - Site 32411 | Mendoza | |
| Argentina | Chiesi Clinical Trial - Site 32413 | Mendoza | |
| Argentina | Chiesi Clinical Trial - Site 32402 | Monte Grande | |
| Argentina | Chiesi Clinical Trial - Site 32406 | Quilmes | |
| Argentina | Chiesi Clinical Trial - Site 32453 | Rosario | |
| Argentina | Chiesi Clinical Trial - Site 32460 | San Fernando | |
| 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 32452 | San Miguel de Tucumán | |
| Argentina | Chiesi Clinical Trial - Site 32461 | San Miguel de Tucumán | |
| Argentina | Chiesi Clinical Trial - Site 32464 | San Miguel De Tucumán | |
| Argentina | Chiesi Clinical Trial - Site 32456 | Santa Fe | |
| Australia | Chiesi Clinical Trial - Site 36453 | Adelaide | |
| Australia | Chiesi Clinical Trial - Site 36454 | Box Hill | |
| Australia | Chiesi Clinical Trial - Site 36455 | Campbelltown | |
| Australia | Chiesi Clinical Trial - Site 36456 | Clayton | |
| Australia | Chiesi Clinical Trial - Site 36451 | South Brisbane | |
| Australia | Chiesi Clinical Trial - Site 36452 | Westmead | |
| Austria | Chiesi Clinical Trial - Site 40402 | Feldbach | |
| Austria | Chiesi Clinical Trial - Site 40404 | Grieskirchen | |
| Austria | Chiesi Clinical Trial - Site 40401 | Linz | |
| Austria | Chiesi Clinical Trial - Site 40403 | Linz | |
| Bosnia and Herzegovina | Chiesi Clinical Trial - Site 070401 | Banja Luka | |
| Bosnia and Herzegovina | Chiesi Clinical Trial - Site 070407 | Doboj | |
| Bosnia and Herzegovina | Chiesi Clinical Trial - Site 070460 | Mostar | |
| Bosnia and Herzegovina | Chiesi Clinical Trial - Site 070404 | Pale | |
| Bosnia and Herzegovina | Chiesi Clinical Trial - Site 070405 | Sarajevo | |
| Bosnia and Herzegovina | Chiesi Clinical Trial - Site 070406 | Sarajevo | |
| Bosnia and Herzegovina | Chiesi Clinical Trial - Site 070403 | Tesanj | |
| Bosnia and Herzegovina | Chiesi Clinical Trial - Site 070402 | Tuzla | |
| Bosnia and Herzegovina | Chiesi Clinical Trial - Site 070463 | Tuzla | |
| Bulgaria | Chiesi Clinical Trial - Site 100435 | Blagoevgrad | |
| Bulgaria | Chiesi Clinical Trial - Site 100434 | Dimitrovgrad | |
| Bulgaria | Chiesi Clinical Trial - Site 100453 | Gabrovo | |
| Bulgaria | Chiesi Clinical Trial - Site 100423 | Haskovo | |
| Bulgaria | Chiesi Clinical Trial - Site 100433 | Kozloduy | |
| Bulgaria | Chiesi Clinical Trial - Site 100455 | Lovech | |
| Bulgaria | Chiesi Clinical Trial - Site 100415 | Montana | |
| Bulgaria | Chiesi Clinical Trial - Site 100432 | Pernik | |
| Bulgaria | Chiesi Clinical Trial - Site 100422 | Pleven | |
| Bulgaria | Chiesi Clinical Trial - Site 100452 | Plovdiv | |
| Bulgaria | Chiesi Clinical Trial - Site 100456 | Plovdiv | |
| Bulgaria | Chiesi Clinical Trial - Site 100437 | Razgrad | |
| Bulgaria | Chiesi Clinical Trial - Site 100412 | Ruse | |
| Bulgaria | Chiesi Clinical Trial - Site 100416 | Ruse | |
| Bulgaria | Chiesi Clinical Trial - Site 100436 | Sevlievo | |
| Bulgaria | Chiesi Clinical Trial - Site 100460 | Sliven | |
| 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 | Sofia | |
| Bulgaria | Chiesi Clinical Trial - Site 100424 | Stara Zagora | |
| Bulgaria | Chiesi Clinical Trial - Site 100454 | Stara Zagora | |
| Bulgaria | Chiesi Clinical Trial - Site 100462 | Veliko Tarnovo | |
| Bulgaria | Chiesi Clinical Trial - Site 100419 | Vidin | |
| Bulgaria | Chiesi Clinical Trial - Site 100457 | Vidin | |
| Chile | Chiesi Clinical Trial - Site 152406 | Concepcion | |
| Chile | Chiesi Clinical Trial - Site 152407 | Quillota | |
| Chile | Chiesi Clinical Trial - Site 152403 | Santiago | |
| Chile | Chiesi Clinical Trial - Site 152404 | Santiago | |
| Chile | Chiesi Clinical Trial - Site 152409 | Talca | |
| Chile | Chiesi Clinical Trial - Site 152401 | Valparaiso | |
| China | Chiesi Clinical Trial - Site 156473 | Baotou | |
| China | Chiesi Clinical Trial - Site 156507 | Baotou | |
| China | Chiesi Clinical Trial - Site 156474 | Beijing | |
| China | Chiesi Clinical Trial - Site 156489 | Beijing | |
| China | Chiesi Clinical Trial - Site 156509 | Beijing | |
| China | Chiesi Clinical Trial - Site 156501 | Changchun | |
| China | Chiesi Clinical Trial - Site 156455 | Changsha | |
| China | Chiesi Clinical Trial - Site 156488 | Changsha | |
| China | Chiesi Clinical Trial - Site 156451 | Chengdu | |
| China | Chiesi Clinical Trial - Site 156490 | Chengdu | |
| China | Chiesi Clinical Trial - Site 156463 | Chongqing | |
| China | Chiesi Clinical Trial - Site 156511 | Chongqing | |
| 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 | Guangzhou | |
| China | Chiesi Clinical Trial - Site 156468 | Haikou | |
| China | Chiesi Clinical Trial - Site 156498 | Hangzhou | |
| China | Chiesi Clinical Trial - Site 156500 | Hangzhou | |
| China | Chiesi Clinical Trial - Site 156510 | Harbin | |
| China | Chiesi Clinical Trial - Site 156486 | Hefei | |
| China | Chiesi Clinical Trial - Site 156503 | Hefei | |
| China | Chiesi Clinical Trial - Site 156483 | Hengyang | |
| China | Chiesi Clinical Trial - Site 156495 | Huanghou | |
| China | Chiesi Clinical Trial - Site 156506 | Huizhou | |
| China | Chiesi Clinical Trial - Site 156456 | Jinan | |
| China | Chiesi Clinical Trial - Site 156485 | Jinhua | |
| China | Chiesi Clinical Trial - Site 156454 | Liaoyang | |
| China | Chiesi Clinical Trial - Site 156453 | Nanchang | |
| China | Chiesi Clinical Trial - Site 156467 | Nanchang | |
| China | Chiesi Clinical Trial - Site 156484 | Nanjing | |
| China | Chiesi Clinical Trial - Site 156496 | Nanjing | |
| China | Chiesi Clinical Trial - Site 156497 | Nanjing | |
| China | Chiesi Clinical Trial - Site 156481 | Pingxiang | |
| China | Chiesi Clinical Trial - Site 156464 | Qingyuan | |
| 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 | Shanghai | |
| China | Chiesi Clinical Trial - Site 156457 | Suzhou | |
| China | Chiesi Clinical Trial - Site 156499 | Taiyuan | |
| China | Chiesi Clinical Trial - Site 156469 | Taizhou | |
| China | Chiesi Clinical Trial - Site 156465 | Tianjin | |
| China | Chiesi Clinical Trial - Site 156480 | Tianjin | |
| China | Chiesi Clinical Trial - Site 156491 | Wuhan | |
| China | Chiesi Clinical Trial - Site 156505 | Wuhan | |
| China | Chiesi Clinical Trial - Site 156492 | Wuxi | |
| China | Chiesi Clinical Trial - Site 156493 | Wuxi | |
| China | Chiesi Clinical Trial - Site 156470 | Xiangtan | |
| China | Chiesi Clinical Trial - Site 156482 | Xining | |
| China | Chiesi Clinical Trial - Site 156478 | Xinxiang | |
| China | Chiesi Clinical Trial - Site 156466 | Xuzhou | |
| China | Chiesi Clinical Trial - Site 156479 | Xuzhou | |
| China | Chiesi Clinical Trial - Site 156508 | Yanji | |
| China | Chiesi Clinical Trial - Site 156459 | Yiyang | |
| China | Chiesi Clinical Trial - Site 156462 | Zhanjiang | |
| Czechia | Chiesi Clinical Trial - Site 203406 | Brandys nad Labem | |
| Czechia | Chiesi Clinical Trial - Site 203418 | Havlickuv Brod | |
| Czechia | Chiesi Clinical Trial - Site 203401 | Jindrichuv Hradec | |
| Czechia | Chiesi Clinical Trial - Site 203410 | Lovosice | |
| Czechia | Chiesi Clinical Trial - Site 203417 | Mesice | |
| Czechia | Chiesi Clinical Trial - Site 203404 | Miroslav | |
| Czechia | Chiesi Clinical Trial - Site 203416 | Mlada Boleslav | |
| Czechia | Chiesi Clinical Trial - Site 203453 | Olomouc | |
| Czechia | Chiesi Clinical Trial - Site 203452 | Prague | |
| Czechia | Chiesi Clinical Trial - Site 203405 | Praha | |
| Czechia | Chiesi Clinical Trial - Site 203407 | Praha | |
| Czechia | Chiesi Clinical Trial - Site 203413 | Praha | |
| Czechia | Chiesi Clinical Trial - Site 203415 | Praha | |
| Czechia | Chiesi Clinical Trial - Site 203402 | Strakonice | |
| Czechia | Chiesi Clinical Trial - Site 203451 | Tabor | |
| Czechia | Chiesi Clinical Trial - Site 203412 | Varnsdorf | |
| 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 | Tbilisi | |
| Germany | Chiesi Clinical Trial - Site 276462 | Bamberg | |
| 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 | Berlin | |
| Germany | Chiesi Clinical Trial - Site 276456 | Cottbus | |
| Germany | Chiesi Clinical Trial - Site 276409 | Darmstadt | |
| Germany | Chiesi Clinical Trial - Site 276403 | Delitzsch | |
| Germany | Chiesi Clinical Trial - Site 276455 | Essen | |
| Germany | Chiesi Clinical Trial - Site 276404 | Frankfurt | |
| Germany | Chiesi Clinical Trial - Site 276401 | Hamburg | |
| Germany | Chiesi Clinical Trial - Site 276413 | Hamburg | |
| Germany | Chiesi Clinical Trial - Site 276463 | Hannover | |
| Germany | Chiesi Clinical Trial - Site 276417 | Koblenz | |
| Germany | Chiesi Clinical Trial - Site 276402 | Leipzig | |
| Germany | Chiesi Clinical Trial - Site 276416 | Leipzig | |
| Germany | Chiesi Clinical Trial - Site 276461 | Leipzig | |
| Germany | Chiesi Clinical Trial - Site 276407 | Mainz | |
| Germany | Chiesi Clinical Trial - Site 276408 | Munich | |
| Germany | Chiesi Clinical Trial - Site 276459 | Münster | |
| Germany | Chiesi Clinical Trial - Site 276418 | Peine | |
| Germany | Chiesi Clinical Trial - Site 276464 | Schleswig | |
| Greece | Chiesi Clinical Trial - Site 300406 | Athens | |
| Greece | Chiesi Clinical Trial - Site 300401 | Heraklion | |
| Greece | Chiesi Clinical Trial - Site 300403 | Ioannina | |
| Greece | Chiesi Clinical Trial - Site 300404 | Thessaloniki | |
| Greece | Chiesi Clinical Trial - Site 300405 | Thessaloniki | |
| Greece | Chiesi Clinical Trial - Site 300407 | Volos | |
| Hungary | Chiesi Clinical Trial - Site 348406 | Balassagyarmat | |
| Hungary | Chiesi Clinical Trial - Site 348401 | Budapest | |
| Hungary | Chiesi Clinical Trial - Site 348457 | Budapest | |
| Hungary | Chiesi Clinical Trial - Site 348459 | Budapest | |
| Hungary | Chiesi Clinical Trial - Site 348405 | Csorna | |
| Hungary | Chiesi Clinical Trial - Site 348412 | Edelény | |
| Hungary | Chiesi Clinical Trial - Site 348408 | Godollo | |
| Hungary | Chiesi Clinical Trial - Site 348451 | Gyula | |
| Hungary | Chiesi Clinical Trial - Site 348409 | Monor | |
| Hungary | Chiesi Clinical Trial - Site 348407 | Nyíregyháza | |
| Hungary | Chiesi Clinical Trial - Site 348413 | Pécs | |
| Hungary | Chiesi Clinical Trial - Site 348452 | Sellye | |
| Hungary | Chiesi Clinical Trial - Site 348458 | Százhalombatta | |
| Hungary | Chiesi Clinical Trial - Site 348410 | Szeged | |
| Hungary | Chiesi Clinical Trial - Site 348461 | Szolnok | |
| Hungary | Chiesi Clinical Trial - Site 348403 | Szombathely | |
| Hungary | Chiesi Clinical Trial - Site 348453 | Tatabanya | |
| Hungary | Chiesi Clinical Trial - Site 348415 | Törökbálint | |
| Israel | Chiesi Clinical Trial - Site 376402 | Ashkelon | |
| Israel | Chiesi Clinical Trial - Site 376401 | Be'er Sheva | |
| Israel | Chiesi Clinical Trial - Site 376411 | Hadera | |
| Israel | Chiesi Clinical Trial - Site 376408 | Haifa | |
| Israel | Chiesi Clinical Trial - Site 376410 | Haifa | |
| Israel | Chiesi Clinical Trial - Site 376403 | Jerusalem | |
| Israel | Chiesi Clinical Trial - Site 376406 | Jerusalem | |
| Israel | Chiesi Clinical Trial - Site 376407 | Kfar Saba | |
| Israel | Chiesi Clinical Trial - Site 376405 | Petach Tikva | |
| Israel | Chiesi Clinical Trial - Site 376404 | Ramat Gan | |
| Israel | Chiesi Clinical Trial - Site 376451 | Tel HaShomer | |
| Israel | Chiesi Clinical Trial - Site 376409 | Tel-Aviv | |
| Italy | Chiesi Clinical Trial - Site 380454 | Brescia | |
| Italy | Chiesi Clinical Trial - Site 380451 | Catania | |
| Italy | Chiesi Clinical Trial - Site 380453 | Ferrara | |
| Italy | Chiesi Clinical Trial - Site 380455 | Roma | |
| Italy | Chiesi Clinical Trial - Site 380452 | Trieste | |
| Mexico | Chiesi Clinical Trial - Site 484402 | Chihuahua | |
| Mexico | Chiesi Clinical Trial - Site 484410 | Chihuahua | |
| Mexico | Chiesi Clinical Trial - Site 484406 | Ciudad de Mexico | |
| Mexico | Chiesi Clinical Trial - Site 484405 | Cordoba | |
| Mexico | Chiesi Clinical Trial - Site 484452 | Durango | |
| 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 | Guadalajara | |
| Mexico | Chiesi Clinical Trial - Site 484403 | Monterrey | |
| Mexico | Chiesi Clinical Trial - Site 484411 | Monterrey | |
| Mexico | Chiesi Clinical Trial - Site 484404 | Veracruz | |
| Netherlands | Chiesi Clinical Trial - Site 528403 | Almere | |
| Netherlands | Chiesi Clinical Trial - Site 528401 | Beek | |
| Netherlands | Chiesi Clinical Trial - Site 528404 | Breda | |
| Netherlands | Chiesi Clinical Trial - Site 528402 | Heerlen | |
| Netherlands | Chiesi Clinical Trial - Site 528405 | Leeuwarden | |
| New Zealand | Chiesi Clinical Trial - Site 554404 | Christchurch | |
| New Zealand | Chiesi Clinical Trial - Site 554402 | Hamilton | |
| New Zealand | Chiesi Clinical Trial - Site 554406 | Wellington | |
| North Macedonia | Chiesi Clinical Trial - Site 807402 | Gostivar | |
| North Macedonia | Chiesi Clinical Trial - Site 807401 | Prilep | |
| North Macedonia | Chiesi Clinical Trial - Site 807452 | Skopje | |
| North Macedonia | Chiesi Clinical Trial - Site 807454 | Skopje | |
| North Macedonia | Chiesi Clinical Trial - Site 807403 | Tetovo | |
| Poland | Chiesi Clinical Trial - Site 616413 | Bialystok | |
| Poland | Chiesi Clinical Trial - Site 616418 | Bialystok | |
| Poland | Chiesi Clinical Trial - Site 616404 | Gizycko | |
| Poland | Chiesi Clinical Trial - Site 616415 | Katowice | |
| Poland | Chiesi Clinical Trial - Site 616422 | Katowice | |
| 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 | Krakow | |
| Poland | Chiesi Clinical Trial - Site 616458 | Lodz | |
| Poland | Chiesi Clinical Trial - Site 616403 | Lódz | |
| Poland | Chiesi Clinical Trial - Site 616423 | Lódz | |
| Poland | Chiesi Clinical Trial - Site 616457 | Lublin | |
| Poland | Chiesi Clinical Trial - Site 616419 | Ostrowiec | |
| Poland | Chiesi Clinical Trial - Site 616456 | Piaseczno | |
| Poland | Chiesi Clinical Trial - Site 616406 | Poznan | |
| Poland | Chiesi Clinical Trial - Site 616408 | Poznan | |
| Poland | Chiesi Clinical Trial - Site 616401 | Sosnowiec | |
| Poland | Chiesi Clinical Trial - Site 616451 | Tarnow | |
| Poland | Chiesi Clinical Trial - Site 616402 | Torun | |
| Poland | Chiesi Clinical Trial - Site 616452 | Wroclaw | |
| Poland | Chiesi Clinical Trial - Site 616454 | Wroclaw | |
| Romania | Chiesi Clinical Trial - Site 642410 | Bacau | |
| Romania | Chiesi Clinical Trial - Site 642452 | Bragadiru | |
| Romania | Chiesi Clinical Trial - Site 642412 | Cluj | |
| 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 642401 | Constan?a | |
| Romania | Chiesi Clinical Trial - Site 642409 | Craiova | |
| Romania | Chiesi Clinical Trial - Site 642411 | Craiova | |
| Romania | Chiesi Clinical Trial - Site 642453 | Deva | |
| Romania | Chiesi Clinical Trial - Site 642414 | Iasi | |
| Romania | Chiesi Clinical Trial - Site 642403 | Oradea | |
| Romania | Chiesi Clinical Trial - Site 642413 | Resca | |
| Romania | Chiesi Clinical Trial - Site 642405 | Timi?oara | |
| Romania | Chiesi Clinical Trial - Site 642415 | Timi?oara | |
| Romania | Chiesi Clinical Trial - Site 642407 | Timisoara | |
| Russian Federation | Chiesi Clinical Trial - Site 643433 | Chelyabinsk | |
| Russian Federation | Chiesi Clinical Trial - Site 643417 | Kazan | |
| Russian Federation | Chiesi Clinical Trial - Site 643462 | Kazan | |
| Russian Federation | Chiesi Clinical Trial - Site 643456 | Kemerovo | |
| Russian Federation | Chiesi Clinical Trial - Site 643401 | Moscow | |
| Russian Federation | Chiesi Clinical Trial - Site 643413 | Moscow | |
| Russian Federation | Chiesi Clinical Trial - Site 643428 | Moscow | |
| Russian Federation | Chiesi Clinical Trial - Site 643460 | Moscow | |
| Russian Federation | Chiesi Clinical Trial - Site 643454 | Moskva | |
| Russian Federation | Chiesi Clinical Trial - Site 643416 | Nizhny Novgorod | |
| Russian Federation | Chiesi Clinical Trial - Site 643403 | Odintsovskiy | |
| Russian Federation | Chiesi Clinical Trial - Site 643457 | Rostov-na-Donu | |
| Russian Federation | Chiesi Clinical Trial - Site 643459 | Rostov-on-Don | |
| Russian Federation | Chiesi Clinical Trial - Site 643404 | Saint Petersburg | |
| Russian Federation | Chiesi Clinical Trial - Site 643406 | Saint Petersburg | |
| Russian Federation | Chiesi Clinical Trial - Site 643408 | Saint Petersburg | |
| Russian Federation | Chiesi Clinical Trial - Site 643414 | Saint Petersburg | |
| Russian Federation | Chiesi Clinical Trial - Site 643423 | Saint Petersburg | |
| Russian Federation | Chiesi Clinical Trial - Site 643424 | Saint Petersburg | |
| Russian Federation | Chiesi Clinical Trial - Site 643431 | Saint Petersburg | |
| Russian Federation | Chiesi Clinical Trial - Site 643451 | Saint-Peterburg | |
| Russian Federation | Chiesi Clinical Trial - Site 643405 | Saint-Petersburg | |
| Russian Federation | Chiesi Clinical Trial - Site 643410 | Saint-Petersburg | |
| Russian Federation | Chiesi Clinical Trial - Site 643412 | Saint-Petersburg | |
| Russian Federation | Chiesi Clinical Trial - Site 643420 | Saint-Petersburg | |
| Russian Federation | Chiesi Clinical Trial - Site 643458 | Sankt-Peterburg | |
| Russian Federation | Chiesi Clinical Trial - Site 643415 | Saratov | |
| Russian Federation | Chiesi Clinical Trial - Site 643425 | Saratov | |
| Russian Federation | Chiesi Clinical Trial - Site 643411 | St. Petersburg | |
| Russian Federation | Chiesi Clinical Trial - Site 643419 | St. Petersburg | |
| Russian Federation | Chiesi Clinical Trial - Site 643421 | Ulyanovsk | |
| Russian Federation | Chiesi Clinical Trial - Site 643402 | Voronezh | |
| Russian Federation | Chiesi Clinical Trial - Site 643407 | Yaroslavl | |
| Russian Federation | Chiesi Clinical Trial - Site 643418 | Yaroslavl | |
| Russian Federation | Chiesi Clinical Trial - Site 643426 | Yaroslavl' | |
| Serbia | Chiesi Clinical Trial - Site 688401 | Belgrade | |
| Serbia | Chiesi Clinical Trial - Site 688402 | Kragujevac | |
| Serbia | Chiesi Clinical Trial - Site 688403 | Krusevac | |
| Serbia | Chiesi Clinical Trial - Site 688404 | Nis | |
| Serbia | Chiesi Clinical Trial - Site 688405 | Nis | |
| Serbia | Chiesi Clinical Trial - Site 688463 | Uzice | |
| Slovakia | Chiesi Clinical Trial - Site 703401 | Bardejov | |
| Slovakia | Chiesi Clinical Trial - Site 703452 | Humenné | |
| Slovakia | Chiesi Clinical Trial - Site 703403 | Košice | |
| Slovakia | Chiesi Clinical Trial - Site 703453 | Levice | |
| Slovakia | Chiesi Clinical Trial - Site 703402 | Spišská Nová Ves | |
| South Africa | Chiesi Clinical Trial - Site 710458 | Benoni | |
| South Africa | Chiesi Clinical Trial - Site 710451 | Bloemfontein | |
| South Africa | Chiesi Clinical Trial - Site 710456 | Centurion | |
| South Africa | Chiesi Clinical Trial - Site 710454 | Durban | |
| South Africa | Chiesi Clinical Trial - Site 710455 | George | |
| South Africa | Chiesi Clinical Trial - Site 710453 | Johannesburg | |
| South Africa | Chiesi Clinical Trial - Site 710452 | Pretoria | |
| Spain | Chiesi Clinical Trial - Site 724454 | Barakaldo | |
| Spain | Chiesi Clinical Trial - Site 724403 | Barcelona | |
| Spain | Chiesi Clinical Trial - Site 724457 | Barcelone | |
| Spain | Chiesi Clinical Trial - Site 724401 | Cordoba | |
| Spain | Chiesi Clinical Trial - Site 724404 | Madrid | |
| Spain | Chiesi Clinical Trial - Site 724405 | Madrid | |
| Spain | Chiesi Clinical Trial - Site 724451 | Madrid | |
| Spain | Chiesi Clinical Trial - Site 724455 | Palma De Mallorca | |
| Spain | Chiesi Clinical Trial - Site 724458 | Pontevedra | |
| Spain | Chiesi Clinical Trial - Site 724452 | Valencia | |
| Spain | Chiesi Clinical Trial - Site 724402 | Zaragoza | |
| Turkey | Chiesi Clinical Trial - Site 792412 | Adana | |
| Turkey | Chiesi Clinical Trial - Site 792410 | Bornova | |
| Turkey | Chiesi Clinical Trial - Site 792415 | Canakkale | |
| Turkey | Chiesi Clinical Trial - Site 792408 | Istanbul | |
| Turkey | Chiesi Clinical Trial - Site 792414 | Kocaeli | |
| Turkey | Chiesi Clinical Trial - Site 792413 | Mersin | |
| Turkey | Chiesi Clinical Trial - Site 792406 | Pamukkale | |
| Turkey | Chiesi Clinical Trial - Site 792411 | Yenisehir | |
| Turkey | Chiesi Clinical Trial - Site 792407 | Zeytinburnu | |
| Ukraine | Chiesi Clinical Trial - Site 804452 | Chernivtsi | |
| Ukraine | Chiesi Clinical Trial - Site 804422 | Dnepropetrovsk | |
| Ukraine | Chiesi Clinical Trial - Site 804458 | Dnipro | |
| Ukraine | Chiesi Clinical Trial - Site 804402 | Ivano-Frankivs'k | |
| Ukraine | Chiesi Clinical Trial - Site 804453 | Ivano-Frankivsk | |
| 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 | Kharkiv | |
| Ukraine | Chiesi Clinical Trial - Site 804403 | Kherson | |
| Ukraine | Chiesi Clinical Trial - Site 804421 | Kiev | |
| Ukraine | Chiesi Clinical Trial - Site 804459 | Kiev | |
| Ukraine | Chiesi Clinical Trial - Site 804420 | Kremenchuk | |
| Ukraine | Chiesi Clinical Trial - Site 804451 | Kryvyi Rih | |
| 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 | Kyiv | |
| Ukraine | Chiesi Clinical Trial - Site 804427 | Odessa | |
| 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 | Vinnytsya | |
| Ukraine | Chiesi Clinical Trial - Site 804428 | Zaporizhya | |
| Ukraine | Chiesi Clinical Trial - Site 804423 | Zaporizhzhia | |
| Ukraine | Chiesi Clinical Trial - Site 804426 | Zaporozhye | |
| United Kingdom | Chiesi Clinical Trial - Site 826410 | Belfast | |
| United Kingdom | Chiesi Clinical Trial - Site 826409 | Bradford | |
| United Kingdom | Chiesi Clinical Trial - Site 826411 | London | |
| United Kingdom | Chiesi Clinical Trial - Site 826412 | Rochdale | |
| United States | Chiesi Clinical Trial - Site 840487 | Cutler Bay | Florida |
| United States | Chiesi Clinical Trial - Site 840404 | Hollywood | Florida |
| United States | Chiesi Clinical Trial - Site 840474 | Kerrville | Texas |
| United States | Chiesi Clinical Trial - Site 840403 | Miami | Florida |
| United States | Chiesi Clinical Trial - Site 840407 | Miami | Florida |
| United States | Chiesi Clinical Trial - Site 840437 | Miami | Florida |
| United States | Chiesi Clinical Trial - Site 840444 | Miami | Florida |
| United States | Chiesi Clinical Trial - Site 840478 | New Windsor | New York |
| United States | Chiesi Clinical Trial - Site 840480 | Northridge | California |
| United States | Chiesi Clinical Trial - Site 840463 | Orlando | Florida |
| United States | Chiesi Clinical Trial - Site 840401 | Peachtree Corners | Georgia |
| United States | Chiesi Clinical Trial - Site 840483 | Philadelphia | Pennsylvania |
| United States | Chiesi Clinical Trial - Site 840409 | Plano | Texas |
| United States | Chiesi Clinical Trial - Site 840481 | San Antonio | Texas |
| United States | Chiesi Clinical Trial - Site 840402 | Sheffield | Alabama |
| Lead Sponsor | Collaborator |
|---|---|
| Chiesi Farmaceutici S.p.A. |
United States, Albania, Argentina, Australia, Austria, Bosnia and Herzegovina, Bulgaria, Chile, China, Czechia, Georgia, Germany, Greece, Hungary, Israel, Italy, Mexico, Netherlands, New Zealand, North Macedonia, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Turkey, Ukraine, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The number of moderate and severe COPD 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 corticosteroid (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. | Up to 52 weeks | ||
| Secondary | The annual rate of severe exacerbation. | Up to 52 weeks | ||
| Secondary | The time to first severe exacerbation. | Up to 52 weeks | ||
| Secondary | The number of on-treatment severe exacerbations. | Up to 52 weeks | ||
| Secondary | Change from baseline (pre-dose visit 2) in pre-dose FEV1 at week 52. | At Week 52 | ||
| Secondary | Change from baseline in SGRQ total and domain scores at week 52. | At week 52 | ||
| Secondary | SGRQ response (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 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. | 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) | Up to 52 weeks | ||
| Secondary | 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. | Up to 52 weeks |
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