Clinical trial NCT04636801: A 52-week, Placebo-controlled Study to Evaluate the Efficacy and Safety of 2 Doses of CHF6001 DPI (Tanimilast), as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis (PILASTER)
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Chronic Bronchitis
PDE4 inhibitor
anti-inflammatory respiratory drug
Tanimilast
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2020-11-19
Enrollment: 3435
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: The number of moderate and severe COPD exacerbations occurring during the planned 52-week treatment period.
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: The time to first moderate or severe exacerbation.
timeFrame: Up to 52 weeks
measure: The annual rate of severe exacerbation.
timeFrame: Up to 52 weeks
measure: The time to first severe exacerbation.
timeFrame: Up to 52 weeks
measure: The number of on-treatment severe exacerbations.
timeFrame: Up to 52 weeks
measure: Change from baseline (pre-dose visit 2) in pre-dose FEV1 at week 52.
timeFrame: At Week 52
measure: Change from baseline in SGRQ total and domain scores at week 52.
timeFrame: At week 52
measure: SGRQ response (change from baseline SGRQ total score ≤ -4) at week 52.
timeFrame: At week 52
measure: Change from baseline to last inter-visit period (week 40-52) in E-RS Total and subscale scores
timeFrame: Up to 52 weeks
measure: E-RS response (change from baseline E-RS Total score ≤ -2) at week 52.
timeFrame: At week 52
measure: 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)
timeFrame: Up to 52 weeks
measure: Time to study medication discontinuation for any reason.
timeFrame: Up to 52 weeks
measure: 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.
timeFrame: Up to 52 weeks
Other outcomes:
Locations:
city: Sheffield
country: United States
facility: Chiesi Clinical Trial - Site 840402
state: Alabama
city: Northridge
country: United States
facility: Chiesi Clinical Trial - Site 840480
state: California
city: Cutler Bay
country: United States
facility: Chiesi Clinical Trial - Site 840487
state: Florida
city: Hollywood
country: United States
facility: Chiesi Clinical Trial - Site 840404
state: Florida
city: Miami
country: United States
facility: Chiesi Clinical Trial - Site 840407
state: Florida
city: Miami
country: United States
facility: Chiesi Clinical Trial - Site 840444
state: Florida
city: Miami
country: United States
facility: Chiesi Clinical Trial - Site 840437
state: Florida
city: Miami
country: United States
facility: Chiesi Clinical Trial - Site 840403
state: Florida
city: Orlando
country: United States
facility: Chiesi Clinical Trial - Site 840463
state: Florida
city: Peachtree Corners
country: United States
facility: Chiesi Clinical Trial - Site 840401
state: Georgia
city: New Windsor
country: United States
facility: Chiesi Clinical Trial - Site 840478
state: New York
city: Philadelphia
country: United States
facility: Chiesi Clinical Trial - Site 840483
state: Pennsylvania
city: Kerrville
country: United States
facility: Chiesi Clinical Trial - Site 840474
state: Texas
city: Plano
country: United States
facility: Chiesi Clinical Trial - Site 840409
state: Texas
city: San Antonio
country: United States
facility: Chiesi Clinical Trial - Site 840481
state: Texas
city: Durres
country: Albania
facility: Chiesi Clinical Trial - Site 8455
city: Durres
country: Albania
facility: Chiesi Clinical Trial - Site 8459
city: Elbasan
country: Albania
facility: Chiesi Clinical Trial - Site 8457
city: Korca
country: Albania
facility: Chiesi Clinical Trial - Site 8460
city: Tirana
country: Albania
facility: Chiesi Clinical Trial - Site 8451
city: Tirana
country: Albania
facility: Chiesi Clinical Trial - Site 8452
city: Tirana
country: Albania
facility: Chiesi Clinical Trial - Site 8453
city: Tirana
country: Albania
facility: Chiesi Clinical Trial - Site 8454
city: Tirana
country: Albania
facility: Chiesi Clinical Trial - Site 8456
city: Tirana
country: Albania
facility: Chiesi Clinical Trial - Site 8458
city: Buenos Aires
country: Argentina
facility: Chiesi Clinical Trial - Site 32415
city: Buenos Aires
country: Argentina
facility: Chiesi Clinical Trial - Site 32407
city: Buenos Aires
country: Argentina
facility: Chiesi Clinical Trial - Site 32410
city: Buenos Aires
country: Argentina
facility: Chiesi Clinical Trial - Site 32454
city: Caba
country: Argentina
facility: Chiesi Clinical Trial - Site 32457
city: Caba
country: Argentina
facility: Chiesi Clinical Trial - Site 32459
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Chiesi Clinical Trial - Site 32414
city: Córdoba
country: Argentina
facility: Chiesi Clinical Trial - Site 32403
city: Córdoba
country: Argentina
facility: Chiesi Clinical Trial - Site 32409
city: Florencio Varela
country: Argentina
facility: Chiesi Clinical Trial - Site 32408
city: Florida
country: Argentina
facility: Chiesi Clinical Trial - Site 32401
city: Forestal Entre Ríos
country: Argentina
facility: Centro de Medicina Respiratoria - Concepcion del Uruguay - site 32463
city: La Plata
country: Argentina
facility: Chiesi Clinical Trial - Site 32455
city: Mar Del Plata
country: Argentina
facility: Chiesi Clinical Trial - Site 32458
city: Mar Del Plata
country: Argentina
facility: Chiesi Clinical Trial - Site 32462
city: Mendoza
country: Argentina
facility: Chiesi Clinical Trial - Site 32405
city: Mendoza
country: Argentina
facility: Chiesi Clinical Trial - Site 32411
city: Mendoza
country: Argentina
facility: Chiesi Clinical Trial - Site 32413
city: Monte Grande
country: Argentina
facility: Chiesi Clinical Trial - Site 32402
city: Quilmes
country: Argentina
facility: Chiesi Clinical Trial - Site 32406
city: Rosario
country: Argentina
facility: Chiesi Clinical Trial - Site 32453
city: San Fernando
country: Argentina
facility: Chiesi Clinical Trial - Site 32460
city: San Miguel De Tucumán
country: Argentina
facility: Chiesi Clinical Trial - Site 32412
city: San Miguel De Tucumán
country: Argentina
facility: Chiesi Clinical Trial - Site 32451
city: San Miguel de Tucumán
country: Argentina
facility: Chiesi Clinical Trial - Site 32452
city: San Miguel de Tucumán
country: Argentina
facility: Chiesi Clinical Trial - Site 32461
city: San Miguel De Tucumán
country: Argentina
facility: Chiesi Clinical Trial - Site 32464
city: Santa Fe
country: Argentina
facility: Chiesi Clinical Trial - Site 32456
city: Adelaide
country: Australia
facility: Chiesi Clinical Trial - Site 36453
city: Box Hill
country: Australia
facility: Chiesi Clinical Trial - Site 36454
city: Campbelltown
country: Australia
facility: Chiesi Clinical Trial - Site 36455
city: Clayton
country: Australia
facility: Chiesi Clinical Trial - Site 36456
city: South Brisbane
country: Australia
facility: Chiesi Clinical Trial - Site 36451
city: Westmead
country: Australia
facility: Chiesi Clinical Trial - Site 36452
city: Feldbach
country: Austria
facility: Chiesi Clinical Trial - Site 40402
city: Grieskirchen
country: Austria
facility: Chiesi Clinical Trial - Site 40404
city: Linz
country: Austria
facility: Chiesi Clinical Trial - Site 40406
city: Linz
country: Austria
facility: Chiesi Clinical Trial - Site 40401
city: Linz
country: Austria
facility: Chiesi Clinical Trial - Site 40403
city: Wels
country: Austria
facility: Chiesi Clinical Trial - Site 40405
city: Banja Luka
country: Bosnia and Herzegovina
facility: Chiesi Clinical Trial - Site 070401
city: Doboj
country: Bosnia and Herzegovina
facility: Chiesi Clinical Trial - Site 070407
city: Mostar
country: Bosnia and Herzegovina
facility: Chiesi Clinical Trial - Site 070460
city: Pale
country: Bosnia and Herzegovina
facility: Chiesi Clinical Trial - Site 070404
city: Sarajevo
country: Bosnia and Herzegovina
facility: OJ Dom zdravlja Novo Sarajevo "Omer Maslić" - Site 70408
city: Sarajevo
country: Bosnia and Herzegovina
facility: Chiesi Clinical Trial - Site 070405
city: Sarajevo
country: Bosnia and Herzegovina
facility: Chiesi Clinical Trial - Site 070406
city: Tesanj
country: Bosnia and Herzegovina
facility: Chiesi Clinical Trial - Site 070403
city: Tuzla
country: Bosnia and Herzegovina
facility: Chiesi Clinical Trial - Site 070402
city: Tuzla
country: Bosnia and Herzegovina
facility: Chiesi Clinical Trial - Site 070463
city: Blagoevgrad
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100435
city: Dimitrovgrad
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100434
city: Gabrovo
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100453
city: Haskovo
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100423
city: Kozloduy
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100433
city: Lovech
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100455
city: Montana
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100415
city: Pernik
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100432
city: Pleven
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100422
city: Plovdiv
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100452
city: Plovdiv
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100456
city: Razgrad
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100437
city: Ruse
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100412
city: Ruse
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100416
city: Sevlievo
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100436
city: Sliven
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100460
city: Sofia
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100409
city: Sofia
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100414
city: Sofia
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100417
city: Sofia
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100418
city: Sofia
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100420
city: Sofia
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100430
city: Sofia
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100431
city: Sofia
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100438
city: Stara Zagora
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100424
city: Stara Zagora
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100454
city: Veliko Tarnovo
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100462
city: Vidin
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100419
city: Vidin
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100457
city: Concepcion
country: Chile
facility: Chiesi Clinical Trial - Site 152406
city: Quillota
country: Chile
facility: Chiesi Clinical Trial - Site 152407
city: Santiago
country: Chile
facility: Chiesi Clinical Trial - Site 152403
city: Santiago
country: Chile
facility: Chiesi Clinical Trial - Site 152404
city: Talca
country: Chile
facility: Chiesi Clinical Trial - Site 152409
city: Valparaiso
country: Chile
facility: Chiesi Clinical Trial - Site 152401
city: Baotou
country: China
facility: Chiesi Clinical Trial - Site 156473
city: Baotou
country: China
facility: Chiesi Clinical Trial - Site 156507
city: Beijing
country: China
facility: Chiesi Clinical Trial - Site 156474
city: Beijing
country: China
facility: Chiesi Clinical Trial - Site 156489
city: Beijing
country: China
facility: Chiesi Clinical Trial - Site 156509
city: Changchun
country: China
facility: Chiesi Clinical Trial - Site 156501
city: Changsha
country: China
facility: Chiesi Clinical Trial - Site 156455
city: Changsha
country: China
facility: Chiesi Clinical Trial - Site 156488
city: Chengdu
country: China
facility: Chiesi Clinical Trial - Site 156451
city: Chengdu
country: China
facility: Chiesi Clinical Trial - Site 156490
city: Chongqing
country: China
facility: Chiesi Clinical Trial - Site 156463
city: Chongqing
country: China
facility: Chiesi Clinical Trial - Site 156511
city: Guangzhou
country: China
facility: Chiesi Clinical Trial - Site 156452
city: Guangzhou
country: China
facility: Chiesi Clinical Trial - Site 156460
city: Guangzhou
country: China
facility: Chiesi Clinical Trial - Site 156471
city: Guangzhou
country: China
facility: Chiesi Clinical Trial - Site 156472
city: Guangzhou
country: China
facility: Chiesi Clinical Trial - Site 156494
city: Guangzhou
country: China
facility: Chiesi Clinical Trial - Site 156504
city: Haikou
country: China
facility: Chiesi Clinical Trial - Site 156468
city: Hangzhou
country: China
facility: Chiesi Clinical Trial - Site 156498
city: Harbin
country: China
facility: Chiesi Clinical Trial - Site 156510
city: Hefei
country: China
facility: Chiesi Clinical Trial - Site 156486
city: Hefei
country: China
facility: Chiesi Clinical Trial - Site 156503
city: Hengyang
country: China
facility: Chiesi Clinical Trial - Site 156483
city: Hohhot
country: China
facility: Chiesi Clinical Trial - Site 156512
city: Huanghou
country: China
facility: Chiesi Clinical Trial - Site 156495
city: Huizhou
country: China
facility: Chiesi Clinical Trial - Site 156506
city: Jinan
country: China
facility: Chiesi Clinical Trial - Site 156456
city: Jinhua
country: China
facility: Chiesi Clinical Trial - Site 156485
city: Liaoyang
country: China
facility: Chiesi Clinical Trial - Site 156454
city: Nanchang
country: China
facility: Chiesi Clinical Trial - Site 156453
city: Nanchang
country: China
facility: Chiesi Clinical Trial - Site 156467
city: Nanjing
country: China
facility: Chiesi Clinical Trial - Site 156484
city: Nanjing
country: China
facility: Chiesi Clinical Trial - Site 156496
city: Nanjing
country: China
facility: Chiesi Clinical Trial - Site 156497
city: Pingxiang
country: China
facility: Chiesi Clinical Trial - Site 156481
city: Qingyuan
country: China
facility: Chiesi Clinical Trial - Site 156464
city: Shanghai
country: China
facility: Chiesi Clinical Trial - Site 156458
city: Shanghai
country: China
facility: Chiesi Clinical Trial - Site 156461
city: Shanghai
country: China
facility: Chiesi Clinical Trial - Site 156475
city: Shanghai
country: China
facility: Chiesi Clinical Trial - Site 156476
city: Shanghai
country: China
facility: Chiesi Clinical Trial - Site 156477
city: Shanghai
country: China
facility: Chiesi Clinical Trial - Site 156487
city: Suzhou
country: China
facility: Chiesi Clinical Trial - Site 156457
city: Taiyuan
country: China
facility: Chiesi Clinical Trial - Site 156499
city: Taizhou
country: China
facility: Chiesi Clinical Trial - Site 156469
city: Tianjin
country: China
facility: Chiesi Clinical Trial - Site 156465
city: Tianjin
country: China
facility: Chiesi Clinical Trial - Site 156480
city: Wuhan
country: China
facility: Chiesi Clinical Trial - Site 156491
city: Wuhan
country: China
facility: Chiesi Clinical Trial - Site 156505
city: Wuxi
country: China
facility: Chiesi Clinical Trial - Site 156492
city: Wuxi
country: China
facility: Chiesi Clinical Trial - Site 156493
city: Xiangtan
country: China
facility: Chiesi Clinical Trial - Site 156470
city: Xining
country: China
facility: Chiesi Clinical Trial - Site 156482
city: Xinxiang
country: China
facility: Chiesi Clinical Trial - Site 156478
city: Xuzhou
country: China
facility: Chiesi Clinical Trial - Site 156466
city: Xuzhou
country: China
facility: Chiesi Clinical Trial - Site 156479
city: Yanji
country: China
facility: Chiesi Clinical Trial - Site 156508
city: Yiyang
country: China
facility: Chiesi Clinical Trial - Site 156459
city: Zhanjiang
country: China
facility: Chiesi Clinical Trial - Site 156462
city: Brandys nad Labem
country: Czechia
facility: Chiesi Clinical Trial - Site 203406
city: Havlickuv Brod
country: Czechia
facility: Chiesi Clinical Trial - Site 203418
city: Jindrichuv Hradec
country: Czechia
facility: Chiesi Clinical Trial - Site 203401
city: Lovosice
country: Czechia
facility: Chiesi Clinical Trial - Site 203410
city: Mesice
country: Czechia
facility: Chiesi Clinical Trial - Site 203417
city: Miroslav
country: Czechia
facility: Chiesi Clinical Trial - Site 203404
city: Mlada Boleslav
country: Czechia
facility: Chiesi Clinical Trial - Site 203416
city: Olomouc
country: Czechia
facility: Chiesi Clinical Trial - Site 203453
city: Prague
country: Czechia
facility: Chiesi Clinical Trial - Site 203452
city: Praha
country: Czechia
facility: Chiesi Clinical Trial - Site 203405
city: Praha
country: Czechia
facility: Chiesi Clinical Trial - Site 203407
city: Praha
country: Czechia
facility: Chiesi Clinical Trial - Site 203413
city: Praha
country: Czechia
facility: Chiesi Clinical Trial - Site 203415
city: Strakonice
country: Czechia
facility: Chiesi Clinical Trial - Site 203402
city: Tabor
country: Czechia
facility: Chiesi Clinical Trial - Site 203451
city: Varnsdorf
country: Czechia
facility: Chiesi Clinical Trial - Site 203412
city: Tbilisi
country: Georgia
facility: Chiesi Clinical Trial - Site 268451
city: Tbilisi
country: Georgia
facility: Chiesi Clinical Trial - Site 268452
city: Tbilisi
country: Georgia
facility: Chiesi Clinical Trial - Site 268453
city: Tbilisi
country: Georgia
facility: Chiesi Clinical Trial - Site 268454
city: Tbilisi
country: Georgia
facility: Chiesi Clinical Trial - Site 268455
city: Tbilisi
country: Georgia
facility: Chiesi Clinical Trial - Site 268456
city: Tbilisi
country: Georgia
facility: Chiesi Clinical Trial - Site 268457
city: Bamberg
country: Germany
facility: Chiesi Clinical Trial - Site 276462
city: Berlin
country: Germany
facility: Chiesi Clinical Trial - Site 276405
city: Berlin
country: Germany
facility: Chiesi Clinical Trial - Site 276406
city: Berlin
country: Germany
facility: Chiesi Clinical Trial - Site 276410
city: Berlin
country: Germany
facility: Chiesi Clinical Trial - Site 276411
city: Berlin
country: Germany
facility: Chiesi Clinical Trial - Site 276415
city: Berlin
country: Germany
facility: Chiesi Clinical Trial - Site 276452
city: Berlin
country: Germany
facility: Chiesi Clinical Trial - Site 276453
city: Berlin
country: Germany
facility: Chiesi Clinical Trial - Site 276457
city: Cottbus
country: Germany
facility: Chiesi Clinical Trial - Site 276456
city: Darmstadt
country: Germany
facility: Chiesi Clinical Trial - Site 276409
city: Delitzsch
country: Germany
facility: Chiesi Clinical Trial - Site 276403
city: Essen
country: Germany
facility: Chiesi Clinical Trial - Site 276455
city: Frankfurt
country: Germany
facility: Chiesi Clinical Trial - Site 276404
city: Hamburg
country: Germany
facility: Chiesi Clinical Trial - Site 276401
city: Hamburg
country: Germany
facility: Chiesi Clinical Trial - Site 276413
city: Hannover
country: Germany
facility: Chiesi Clinical Trial - Site 276463
city: Koblenz
country: Germany
facility: Chiesi Clinical Trial - Site 276417
city: Leipzig
country: Germany
facility: Chiesi Clinical Trial - Site 276402
city: Leipzig
country: Germany
facility: Chiesi Clinical Trial - Site 276416
city: Leipzig
country: Germany
facility: Chiesi Clinical Trial - Site 276461
city: Mainz
country: Germany
facility: Chiesi Clinical Trial - Site 276407
city: Munich
country: Germany
facility: Chiesi Clinical Trial - Site 276408
city: Münster
country: Germany
facility: Chiesi Clinical Trial - Site 276459
city: Peine
country: Germany
facility: Chiesi Clinical Trial - Site 276418
city: Schleswig
country: Germany
facility: Chiesi Clinical Trial - Site 276464
city: Athens
country: Greece
facility: Chiesi Clinical Trial - Site 300406
city: Heraklion
country: Greece
facility: Chiesi Clinical Trial - Site 300401
city: Ioannina
country: Greece
facility: Chiesi Clinical Trial - Site 300403
city: Thessaloniki
country: Greece
facility: Chiesi Clinical Trial - Site 300404
city: Thessaloniki
country: Greece
facility: Chiesi Clinical Trial - Site 300405
city: Volos
country: Greece
facility: Chiesi Clinical Trial - Site 300407
city: Balassagyarmat
country: Hungary
facility: Chiesi Clinical Trial - Site 348406
city: Budapest
country: Hungary
facility: Chiesi Clinical Trial - Site 348401
city: Budapest
country: Hungary
facility: Chiesi Clinical Trial - Site 348457
city: Budapest
country: Hungary
facility: Chiesi Clinical Trial - Site 348459
city: Csorna
country: Hungary
facility: Chiesi Clinical Trial - Site 348405
city: Edelény
country: Hungary
facility: Chiesi Clinical Trial - Site 348412
city: Godollo
country: Hungary
facility: Chiesi Clinical Trial - Site 348408
city: Gyula
country: Hungary
facility: Chiesi Clinical Trial - Site 348451
city: Monor
country: Hungary
facility: Chiesi Clinical Trial - Site 348409
city: Nyíregyháza
country: Hungary
facility: Chiesi Clinical Trial - Site 348407
city: Pécs
country: Hungary
facility: Chiesi Clinical Trial - Site 348413
city: Sellye
country: Hungary
facility: Chiesi Clinical Trial - Site 348452
city: Szeged
country: Hungary
facility: Chiesi Clinical Trial - Site 348410
city: Szolnok
country: Hungary
facility: Chiesi Clinical Trial - Site 348461
city: Szombathely
country: Hungary
facility: Chiesi Clinical Trial - Site 348403
city: Százhalombatta
country: Hungary
facility: Chiesi Clinical Trial - Site 348458
city: Tatabanya
country: Hungary
facility: Chiesi Clinical Trial - Site 348453
city: Törökbálint
country: Hungary
facility: Chiesi Clinical Trial - Site 348415
city: Ashkelon
country: Israel
facility: Chiesi Clinical Trial - Site 376402
city: Be'er Sheva
country: Israel
facility: Chiesi Clinical Trial - Site 376401
city: Haifa
country: Israel
facility: Chiesi Clinical Trial - Site 376408
city: Jerusalem
country: Israel
facility: Chiesi Clinical Trial - Site 376403
city: Jerusalem
country: Israel
facility: Chiesi Clinical Trial - Site 376406
city: Kfar Saba
country: Israel
facility: Chiesi Clinical Trial - Site 376407
city: Petach Tikva
country: Israel
facility: Chiesi Clinical Trial - Site 376405
city: Ramat Gan
country: Israel
facility: Chiesi Clinical Trial - Site 376404
city: Tel HaShomer
country: Israel
facility: Chiesi Clinical Trial - Site 376451
city: Tel-Aviv
country: Israel
facility: Chiesi Clinical Trial - Site 376409
city: Brescia
country: Italy
facility: Chiesi Clinical Trial - Site 380454
city: Catania
country: Italy
facility: Chiesi Clinical Trial - Site 380451
city: Ferrara
country: Italy
facility: Chiesi Clinical Trial - Site 380453
city: Roma
country: Italy
facility: Chiesi Clinical Trial - Site 380455
city: Trieste
country: Italy
facility: Chiesi Clinical Trial - Site 380452
city: Chihuahua
country: Mexico
facility: Chiesi Clinical Trial - Site 484402
city: Chihuahua
country: Mexico
facility: Chiesi Clinical Trial - Site 484410
city: Ciudad de Mexico
country: Mexico
facility: Chiesi Clinical Trial - Site 484406
city: Cordoba
country: Mexico
facility: Chiesi Clinical Trial - Site 484405
city: Durango
country: Mexico
facility: Chiesi Clinical Trial - Site 484452
city: Guadalajara
country: Mexico
facility: Chiesi Clinical Trial - Site 484401
city: Guadalajara
country: Mexico
facility: Chiesi Clinical Trial - Site 484407
city: Guadalajara
country: Mexico
facility: Chiesi Clinical Trial - Site 484409
city: Guadalajara
country: Mexico
facility: Chiesi Clinical Trial - Site 484453
city: Monterrey
country: Mexico
facility: Chiesi Clinical Trial - Site 484403
city: Monterrey
country: Mexico
facility: Chiesi Clinical Trial - Site 484411
city: Veracruz
country: Mexico
facility: Chiesi Clinical Trial - Site 484404
city: Almere
country: Netherlands
facility: Chiesi Clinical Trial - Site 528403
city: Beek
country: Netherlands
facility: Chiesi Clinical Trial - Site 528401
city: Breda
country: Netherlands
facility: Chiesi Clinical Trial - Site 528404
city: Heerlen
country: Netherlands
facility: Chiesi Clinical Trial - Site 528402
city: Leeuwarden
country: Netherlands
facility: Chiesi Clinical Trial - Site 528405
city: Christchurch
country: New Zealand
facility: Chiesi Clinical Trial - Site 554404
city: Hamilton
country: New Zealand
facility: Chiesi Clinical Trial - Site 554402
city: Wellington
country: New Zealand
facility: Chiesi Clinical Trial - Site 554406
city: Gostivar
country: North Macedonia
facility: Chiesi Clinical Trial - Site 807402
city: Prilep
country: North Macedonia
facility: Chiesi Clinical Trial - Site 807401
city: Skopje
country: North Macedonia
facility: Chiesi Clinical Trial - Site 807452
city: Skopje
country: North Macedonia
facility: Chiesi Clinical Trial - Site 807454
city: Struga
country: North Macedonia
facility: General Hospital-Struga - Site 807405
city: Strumica
country: North Macedonia
facility: General Hospital-Strumica - Site 807406
city: Tetovo
country: North Macedonia
facility: Chiesi Clinical Trial - Site 807403
city: Veles
country: North Macedonia
facility: General Hospital - Veles - Site 807404
city: Bialystok
country: Poland
facility: Chiesi Clinical Trial - Site 616413
city: Bialystok
country: Poland
facility: Chiesi Clinical Trial - Site 616418
city: Bielsko-Biala
country: Poland
facility: HolsaClinical - Gyncentrum Bielsko-Biala - Site 616460
city: Gizycko
country: Poland
facility: Chiesi Clinical Trial - Site 616404
city: Katowice
country: Poland
facility: Chiesi Clinical Trial - Site 616415
city: Katowice
country: Poland
facility: Chiesi Clinical Trial - Site 616422
city: Krakow
country: Poland
facility: Chiesi Clinical Trial - Site 616409
city: Krakow
country: Poland
facility: Chiesi Clinical Trial - Site 616411
city: Krakow
country: Poland
facility: Chiesi Clinical Trial - Site 616414
city: Krakow
country: Poland
facility: Chiesi Clinical Trial - Site 616455
city: Lodz
country: Poland
facility: Chiesi Clinical Trial - Site 616458
city: Lublin
country: Poland
facility: Chiesi Clinical Trial - Site 616457
city: Ostrowiec
country: Poland
facility: Chiesi Clinical Trial - Site 616419
city: Piaseczno
country: Poland
facility: Chiesi Clinical Trial - Site 616456
city: Poznan
country: Poland
facility: Chiesi Clinical Trial - Site 616406
city: Poznan
country: Poland
facility: Chiesi Clinical Trial - Site 616408
city: Sosnowiec
country: Poland
facility: Chiesi Clinical Trial - Site 616401
city: Tarnow
country: Poland
facility: Chiesi Clinical Trial - Site 616451
city: Torun
country: Poland
facility: Chiesi Clinical Trial - Site 616402
city: Wroclaw
country: Poland
facility: Chiesi Clinical Trial - Site 616452
city: Wroclaw
country: Poland
facility: Chiesi Clinical Trial - Site 616454
city: Łódź
country: Poland
facility: AmiCare Medical Centre - Site 616459
city: Łódź
country: Poland
facility: Chiesi Clinical Trial - Site 616403
city: Łódź
country: Poland
facility: Chiesi Clinical Trial - Site 616423
city: Bacau
country: Romania
facility: Chiesi Clinical Trial - Site 642410
city: Bragadiru
country: Romania
facility: Chiesi Clinical Trial - Site 642452
city: Cluj-Napoca
country: Romania
facility: Chiesi Clinical Trial - Site 642402
city: Cluj-Napoca
country: Romania
facility: Chiesi Clinical Trial - Site 642404
city: Cluj-Napoca
country: Romania
facility: Chiesi Clinical Trial - Site 642406
city: Cluj-Napoca
country: Romania
facility: Chiesi Clinical Trial - Site 642408
city: Cluj-Napoca
country: Romania
facility: Chiesi Clinical Trial - Site 642454
city: Cluj
country: Romania
facility: Chiesi Clinical Trial - Site 642412
city: Constanța
country: Romania
facility: Chiesi Clinical Trial - Site 642401
city: Craiova
country: Romania
facility: Chiesi Clinical Trial - Site 642409
city: Craiova
country: Romania
facility: Chiesi Clinical Trial - Site 642411
city: Deva
country: Romania
facility: Chiesi Clinical Trial - Site 642453
city: Iasi
country: Romania
facility: Chiesi Clinical Trial - Site 642414
city: Oradea
country: Romania
facility: Chiesi Clinical Trial - Site 642403
city: Resca
country: Romania
facility: Chiesi Clinical Trial - Site 642413
city: Timisoara
country: Romania
facility: Chiesi Clinical Trial - Site 642407
city: Timișoara
country: Romania
facility: Chiesi Clinical Trial - Site 642405
city: Timișoara
country: Romania
facility: Chiesi Clinical Trial - Site 642415
city: Chelyabinsk
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643433
city: Kazan
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643417
city: Kazan
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643462
city: Kemerovo
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643456
city: Moscow
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643401
city: Moscow
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643413
city: Moscow
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643428
city: Moscow
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643460
city: Moskva
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643454
city: Nizhny Novgorod
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643416
city: Odintsovskiy
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643403
city: Rostov-na-Donu
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643457
city: Rostov-on-Don
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643459
city: Saint Petersburg
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643404
city: Saint Petersburg
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643406
city: Saint Petersburg
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643408
city: Saint Petersburg
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643414
city: Saint Petersburg
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643423
city: Saint Petersburg
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643424
city: Saint Petersburg
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643431
city: Saint-Peterburg
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643451
city: Saint-Petersburg
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643405
city: Saint-Petersburg
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643410
city: Saint-Petersburg
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643412
city: Saint-Petersburg
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643420
city: Sankt-Peterburg
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643458
city: Saratov
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643415
city: Saratov
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643425
city: St. Petersburg
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643411
city: St. Petersburg
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643419
city: Ulyanovsk
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643421
city: Voronezh
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643402
city: Yaroslavl'
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643426
city: Yaroslavl
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643407
city: Yaroslavl
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643418
city: Belgrade
country: Serbia
facility: Kliničko Bolnički Centar Zvezdara - Site 688459
city: Belgrade
country: Serbia
facility: Chiesi Clinical Trial - Site 688401
city: Kragujevac
country: Serbia
facility: Klinički Centar Kragujevac - Site 688456
city: Kragujevac
country: Serbia
facility: Chiesi Clinical Trial - Site 688402
city: Krusevac
country: Serbia
facility: Chiesi Clinical Trial - Site 688403
city: Nis
country: Serbia
facility: Chiesi Clinical Trial - Site 688404
city: Nis
country: Serbia
facility: Chiesi Clinical Trial - Site 688405
city: Sremska Kamenica
country: Serbia
facility: Institut za Plućne Bolesti Sremska Kamenica - Site 688464
city: Sremska Kamenica
country: Serbia
facility: Institute for Pulmonary Diseases of Vojvodina - Site 688466
city: Uzice
country: Serbia
facility: Chiesi Clinical Trial - Site 688463
city: Bardejov
country: Slovakia
facility: Chiesi Clinical Trial - Site 703401
city: Humenné
country: Slovakia
facility: Chiesi Clinical Trial - Site 703452
city: Košice
country: Slovakia
facility: Chiesi Clinical Trial - Site 703403
city: Levice
country: Slovakia
facility: Chiesi Clinical Trial - Site 703453
city: Spišská Nová Ves
country: Slovakia
facility: Chiesi Clinical Trial - Site 703402
city: Benoni
country: South Africa
facility: Chiesi Clinical Trial - Site 710458
city: Bloemfontein
country: South Africa
facility: Chiesi Clinical Trial - Site 710451
city: Centurion
country: South Africa
facility: Chiesi Clinical Trial - Site 710456
city: Durban
country: South Africa
facility: Chiesi Clinical Trial - Site 710454
city: George
country: South Africa
facility: Chiesi Clinical Trial - Site 710455
city: Johannesburg
country: South Africa
facility: Chiesi Clinical Trial - Site 710453
city: Pretoria
country: South Africa
facility: Chiesi Clinical Trial - Site 710452
city: Barakaldo
country: Spain
facility: Chiesi Clinical Trial - Site 724454
city: Barcelona
country: Spain
facility: Chiesi Clinical Trial - Site 724403
city: Barcelone
country: Spain
facility: Chiesi Clinical Trial - Site 724457
city: Cordoba
country: Spain
facility: Chiesi Clinical Trial - Site 724401
city: Madrid
country: Spain
facility: Chiesi Clinical Trial - Site 724404
city: Madrid
country: Spain
facility: Chiesi Clinical Trial - Site 724405
city: Madrid
country: Spain
facility: Chiesi Clinical Trial - Site 724451
city: Palma De Mallorca
country: Spain
facility: Chiesi Clinical Trial - Site 724455
city: Pontevedra
country: Spain
facility: Chiesi Clinical Trial - Site 724458
city: Valencia
country: Spain
facility: Chiesi Clinical Trial - Site 724452
city: Zaragoza
country: Spain
facility: Chiesi Clinical Trial - Site 724402
city: Adana
country: Turkey
facility: Chiesi Clinical Trial - Site 792412
city: Bornova
country: Turkey
facility: Chiesi Clinical Trial - Site 792410
city: Canakkale
country: Turkey
facility: Chiesi Clinical Trial - Site 792415
city: Istanbul
country: Turkey
facility: Chiesi Clinical Trial - Site 792408
city: Kocaeli
country: Turkey
facility: Chiesi Clinical Trial - Site 792414
city: Mersin
country: Turkey
facility: Chiesi Clinical Trial - Site 792413
city: Pamukkale
country: Turkey
facility: Chiesi Clinical Trial - Site 792406
city: Yenişehir
country: Turkey
facility: Chiesi Clinical Trial - Site 792411
city: Zeytinburnu
country: Turkey
facility: Chiesi Clinical Trial - Site 792407
city: Chernivtsi
country: Ukraine
facility: LLC "Euromedservice" - Site 804463
city: Chernivtsi
country: Ukraine
facility: Chiesi Clinical Trial - Site 804452
city: Dnepropetrovsk
country: Ukraine
facility: Chiesi Clinical Trial - Site 804422
city: Dnipro
country: Ukraine
facility: Chiesi Clinical Trial - Site 804458
city: Ivano-Frankivs'k
country: Ukraine
facility: Ivano-Frankivsk City Clinical Hospital No. 1 - Site 804453
city: Ivano-Frankivs'k
country: Ukraine
facility: The Ivano-Frankivsk National Medical Univeristy - Site 804465
city: Ivano-Frankivs'k
country: Ukraine
facility: Chiesi Clinical Trial - Site 804402
city: Ivano-Frankivsk
country: Ukraine
facility: Chiesi Clinical Trial - Site 804453
city: Kharkiv
country: Ukraine
facility: Chiesi Clinical Trial - Site 804404
city: Kharkiv
country: Ukraine
facility: Chiesi Clinical Trial - Site 804405
city: Kharkiv
country: Ukraine
facility: Chiesi Clinical Trial - Site 804406
city: Kharkiv
country: Ukraine
facility: Chiesi Clinical Trial - Site 804409
city: Kharkiv
country: Ukraine
facility: Chiesi Clinical Trial - Site 804450
city: Kharkiv
country: Ukraine
facility: Chiesi Clinical Trial - Site 804457
city: Kherson
country: Ukraine
facility: Chiesi Clinical Trial - Site 804403
city: Kiev
country: Ukraine
facility: Chiesi Clinical Trial - Site 804421
city: Kiev
country: Ukraine
facility: Chiesi Clinical Trial - Site 804459
city: Kramatorsk
country: Ukraine
facility: Municipal Non-profit Enterpirse-Regional Territorial Medical - Site 804454
city: Kremenchuk
country: Ukraine
facility: Chiesi Clinical Trial - Site 804420
city: Kryvyi Rih
country: Ukraine
facility: Chiesi Clinical Trial - Site 804451
city: Kyiv
country: Ukraine
facility: ARENSIA Exploratory Medicine Medical Center - Site 804468
city: Kyiv
country: Ukraine
facility: Medical Center- OkClinic of International Institute of Clinical Studies, LLC - Site 804466
city: Kyiv
country: Ukraine
facility: Chiesi Clinical Trial - Site 804401
city: Kyiv
country: Ukraine
facility: Chiesi Clinical Trial - Site 804408
city: Kyiv
country: Ukraine
facility: Chiesi Clinical Trial - Site 804411
city: Kyiv
country: Ukraine
facility: Chiesi Clinical Trial - Site 804412
city: Kyiv
country: Ukraine
facility: Chiesi Clinical Trial - Site 804416
city: Kyiv
country: Ukraine
facility: Chiesi Clinical Trial - Site 804460
city: Kyiv
country: Ukraine
facility: Chiesi Clinical Trial - Site 804462
city: Odessa
country: Ukraine
facility: Chiesi Clinical Trial - Site 804427
city: Poltava
country: Ukraine
facility: Limited Liability Company Medical and Diagnostic Center "Medion" - Site 804407
city: Vinnytsia
country: Ukraine
facility: Chiesi Clinical Trial - Site 804415
city: Vinnytsia
country: Ukraine
facility: Chiesi Clinical Trial - Site 804417
city: Vinnytsia
country: Ukraine
facility: Chiesi Clinical Trial - Site 804456
city: Vinnytsya
country: Ukraine
facility: Chiesi Clinical Trial - Site 804455
city: Zaporizhzhia
country: Ukraine
facility: Chiesi Clinical Trial - Site 804423
city: Zaporozhye
country: Ukraine
facility: Chiesi Clinical Trial - Site 804426
city: Zhytomyr
country: Ukraine
facility: Central City Hospital No.1 - Zhytomyr - Site 804467
city: Belfast
country: United Kingdom
facility: Chiesi Clinical Trial - Site 826410
city: Bradford
country: United Kingdom
facility: Chiesi Clinical Trial - Site 826409
city: London
country: United Kingdom
facility: Chiesi Clinical Trial - Site 826411
city: Rochdale
country: United Kingdom
facility: Chiesi Clinical Trial - Site 826412
Study officials:
affiliation: LungenClinic Grosshansdorf GmbH Wöhrendamm 80 22927 Großhansdorf GERMANY
name: Klaus F. Rabe, Prof.
role: PRINCIPAL_INVESTIGATOR
References: