Clinical trial NCT04636814: A 52-week, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg) Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI (Tanimilast) as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis. (PILLAR)
Official 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.
Study type: INTERVENTIONAL
Overall status: 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: 3980
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 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.


Eligibility criteria: Inclusion Criteria:

* Adults aged ≥ 40 years, with COPD and with chronic bronchitis.
* Current smokers or ex-smokers (history of ≥10 pack years).
* Post-bronchodilator FEV1 \<50% of the patient predicted normal value and FEV1/FVC ratio \< 0.7.
* At least, one moderate or severe COPD exacerbation in the previous year.
* CAT score ≥10.
* Subjects on regular maintenance triple therapy for at least 12 months prior to screening and receiving regular maintenance triple therapy for at least 3 months prior to screening visit.

Exclusion Criteria:

* Subjects with current asthma.
* Subjects with moderate or severe COPD exacerbation 4 weeks before study entry and randomisation
* Subjects with known α-1 antitrypsin deficiency as the underlying cause of COPD.
* Subjects with primary diagnosis of emphysema not related to COPD.
* Subjects with known respiratory disorders other than COPD.
* Subjects with lung volume reduction surgery.
* Subjects with active cancer or a history of lung cancer.
* Subjects under Roflumilast treatment within 6 months before study entry.
* Subjects with a diagnosis of depression, generalised anxiety disorder, suicidal ideation.
* Subjects with clinically significant cardiovascular condition.
* Subjects with neurological disease.
* Subjects with clinically significant laboratory abnormalities.
* Subjects with moderate or severe hepatic impairment.

Primary outcomes:
measure: The number of moderate and severe 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 exacerbations.
timeFrame: Up to 52 weeks
measure: The time to first severe exacerbation.
timeFrame: Up to 52 weeks
measure: The number of all on-treatment severe exacerbations.
timeFrame: Up to 52 weeks
measure: The number of all on-treatment exacerbations requiring systemic corticosteroids.
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 Saint Georges Respiratory Questionnaire (SGRQ) total and domain scores at week 52.
timeFrame: At week 52
measure: Saint Georges Respiratory Questionnaire response (SGRQ) (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 EXACT-Respiratory Symptoms (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
measure: 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.
timeFrame: Up to 52 weeks
measure: Key Secondary Variable: Change from baseline in SGRQ Total score at week 52
timeFrame: At week 52
Other outcomes:
Locations:
city: Andalusia
country: United States
facility: Chiesi Clinical Trial - Site 840635
state: Alabama
city: Foley
country: United States
facility: Chiesi Clinical Trial - Site 840614
state: Alabama
city: Guntersville
country: United States
facility: Chiesi Clinical Trial - Site 840670
state: Alabama
city: Mobile
country: United States
facility: Chiesi Clinical Trial - Site 840720
state: Alabama
city: Saraland
country: United States
facility: Chiesi Clinical Trial - Site 840643
state: Alabama
city: Phoenix
country: United States
facility: Chiesi Clinical Trial - Site 840638
state: Arizona
city: Conway
country: United States
facility: Chiesi Clinical Trial - Site 840684
state: Arkansas
city: Laguna Hills
country: United States
facility: Chiesi Clinical Trial - Site 840675
state: California
city: Los Angeles
country: United States
facility: Chiesi Clinical Trial - Site 840666
state: California
city: Newport Beach
country: United States
facility: Chiesi Clinical Trial - Site 840511
state: California
city: Northridge
country: United States
facility: Chiesi Clinical Trial - Site 840680
state: California
city: Northridge
country: United States
facility: Chiesi Clinical Trial - Site 840605
state: California
city: Pomona
country: United States
facility: Chiesi Clinical Trial - Site 840700
state: California
city: Westminster
country: United States
facility: Chiesi Clinical Trial - Site 840531
state: California
city: Centennial
country: United States
facility: Chiesi Clinical Trial - Site 840636
state: Colorado
city: Lakewood
country: United States
facility: Chiesi Clinical Trial - Site 840688
state: Colorado
city: Brooksville
country: United States
facility: Chiesi Clinical Trial - Site 840735
state: Florida
city: Chiefland
country: United States
facility: Chiesi Clinical Trial - Site 840513
state: Florida
city: Clearwater
country: United States
facility: Chiesi Clinical Trial - Site 840652
state: Florida
city: Clearwater
country: United States
facility: Chiesi Clinical Trial - Site 840569
state: Florida
city: Coral Gables
country: United States
facility: Chiesi Clinical Trial - Site 840545
state: Florida
city: Cutler Bay
country: United States
facility: Chiesi Clinical Trial - Site 840603
state: Florida
city: Cutler Bay
country: United States
facility: Chiesi Clinical Trial - Site 840587
state: Florida
city: Cutler Bay
country: United States
facility: Chiesi Clinical Trial - Site 840568
state: Florida
city: Daytona Beach
country: United States
facility: Chiesi Clinical Trial - Site840539
state: Florida
city: DeBary
country: United States
facility: Chiesi Clinical Trial - Site 840554
state: Florida
city: Doral
country: United States
facility: Chiesi Clinical Trial - Site 840625
state: Florida
city: Doral
country: United States
facility: Chiesi Clinical Trial - Site 840572
state: Florida
city: Hialeah Gardens
country: United States
facility: Chiesi Clinical Trial - Site 840637
state: Florida
city: Hialeah
country: United States
facility: Chiesi Clinical Trial - Site 840685
state: Florida
city: Hialeah
country: United States
facility: Chiesi Clinical Trial - Site 840504
state: Florida
city: Hialeah
country: United States
facility: Chiesi Clinical Trial - Site 840639
state: Florida
city: Hialeah
country: United States
facility: Chiesi Clinical Trial - Site 840582
state: Florida
city: Hialeah
country: United States
facility: Chiesi Clinical Trial - Site 840617
state: Florida
city: Hialeah
country: United States
facility: Chiesi Clinical Trial - Site 840514
state: Florida
city: Hollywood
country: United States
facility: Chiesi Clinical Trial - Site 840509
state: Florida
city: Hollywood
country: United States
facility: Chiesi Clinical Trial - Site 840730
state: Florida
city: Homestead
country: United States
facility: Chiesi Clinical Trial - Site 840565
state: Florida
city: Loxahatchee Groves
country: United States
facility: Chiesi Clinical Trial - Site 840674
state: Florida
city: Melbourne
country: United States
facility: Chiesi Clinical Trial - Site 840732
state: Florida
city: Miami Gardens
country: United States
facility: Chiesi Clinical Trial - Site 840506
state: Florida
city: Miami Lakes
country: United States
facility: Chiesi Clinical Trial - Site 840608
state: Florida
city: Miami
country: United States
facility: Chiesi Clinical Trial - Site 840624
state: Florida
city: Miami
country: United States
facility: Chiesi Clinical Trial - Site 840596
state: Florida
city: Miami
country: United States
facility: Chiesi Clinical Trial - Site 840556
state: Florida
city: Miami
country: United States
facility: Chiesi Clinical Trial - Site 840602
state: Florida
city: Miami
country: United States
facility: Chiesi Clinical Trial - Site 840507
state: Florida
city: Miami
country: United States
facility: Chiesi Clinical Trial - Site 840519
state: Florida
city: Miami
country: United States
facility: Chiesi Clinical Trial - Site 840505
state: Florida
city: Miami
country: United States
facility: Chiesi Clinical Trial - Site 840644
state: Florida
city: Miami
country: United States
facility: Chiesi Clinical Trial - Site 840557
state: Florida
city: Miami
country: United States
facility: Chiesi Clinical Trial - Site 840588
state: Florida
city: Miami
country: United States
facility: Chiesi Clinical Trial - Site 840618
state: Florida
city: Miami
country: United States
facility: Chiesi Clinical Trial - Site 840525
state: Florida
city: Miami
country: United States
facility: Chiesi Clinical Trial - Site 840656
state: Florida
city: Miami
country: United States
facility: Chiesi Clinical Trial - Site 840622
state: Florida
city: Miami
country: United States
facility: Chiesi Clinical Trial - Site 840537
state: Florida
city: Miami
country: United States
facility: Chiesi Clinical Trial - Site 840691
state: Florida
city: Miami
country: United States
facility: Chiesi Clinical Trial - Site 840503
state: Florida
city: Miami
country: United States
facility: Chiesi Clinical Trial - Site 840694
state: Florida
city: Miami
country: United States
facility: Chiesi Clinical Trial - Site 840630
state: Florida
city: Orlando
country: United States
facility: Chiesi Clinical Trial - Site 840524
state: Florida
city: Orlando
country: United States
facility: Chiesi Clinical Trial - Site 840563
state: Florida
city: Pembroke Pines
country: United States
facility: Chiesi Clinical Trial - Site 840702
state: Florida
city: Pembroke Pines
country: United States
facility: Chiesi Clinical Trial - Site 840502
state: Florida
city: Pembroke Pines
country: United States
facility: Chiesi Clinical Trial - Site 840550
state: Florida
city: Pompano Beach
country: United States
facility: Chiesi Clinical Trial - Site 840527
state: Florida
city: Saint Petersburg
country: United States
facility: Chiesi Clinical Trial - Site 840699
state: Florida
city: Saint Petersburg
country: United States
facility: Chiesi Clinical Trial - Site 840697
state: Florida
city: South Miami
country: United States
facility: Chiesi Clinical Trial - Site 840654
state: Florida
city: Tampa
country: United States
facility: Chiesi Clinical Trial - Site 840567
state: Florida
city: Winter Park
country: United States
facility: Chiesi Clinical Trial - Site 840632
state: Florida
city: Adairsville
country: United States
facility: Chiesi Clinical Trial - Site 840542
state: Georgia
city: College Park
country: United States
facility: Chiesi Clinical Trial - Site 840728
state: Georgia
city: Columbus
country: United States
facility: Chiesi Clinical Trial - Site 840717
state: Georgia
city: Cordele
country: United States
facility: Chiesi Clinical Trial - Site 840710
state: Georgia
city: East Point
country: United States
facility: Chiesi Clinical Trial - Site 840689
state: Georgia
city: Stonecrest
country: United States
facility: Chiesi Clinical Trial - Site 840726
state: Georgia
city: Valdosta
country: United States
facility: Chiesi Clinical Trial - Site 840564
state: Georgia
city: Muncie
country: United States
facility: Chiesi Clinical Trial - Site 840724
state: Indiana
city: Zachary
country: United States
facility: Chiesi Clinical Trial - Site 840672
state: Louisiana
city: Annapolis
country: United States
facility: Chiesi Clinical Trial - Site 840645
state: Maryland
city: Baltimore
country: United States
facility: Chiesi Clinical Trial - Site 840661
state: Maryland
city: North Dartmouth
country: United States
facility: Chiesi Clinical Trial - Site 840707
state: Massachusetts
city: Troy
country: United States
facility: Chiesi Clinical Trial - Site 840657
state: Michigan
city: Port Gibson
country: United States
facility: Chiesi Clinical Trial - Site 840658
state: Mississippi
city: Saint Charles
country: United States
facility: Chiesi Clinical Trial - Site 840641
state: Missouri
city: Saint Louis
country: United States
facility: Chiesi Clinical Trial - Site 840714
state: Missouri
city: Saint Louis
country: United States
facility: Chiesi Clinical Trial - Site 840541
state: Missouri
city: Saint Louis
country: United States
facility: Chiesi Clinical Trial - Site 840669
state: Missouri
city: Omaha
country: United States
facility: Chiesi Clinical Trial - Site 840686
state: Nebraska
city: Henderson
country: United States
facility: Chiesi Clinical Trial - Site 840703
state: Nevada
city: Las Vegas
country: United States
facility: Chiesi Clinical Trial - Site 840529
state: Nevada
city: North Las Vegas
country: United States
facility: Chiesi Clinical Trial - Site 840701
state: Nevada
city: Bayonne
country: United States
facility: Chiesi Clinical Trial - Site 840722
state: New Jersey
city: Bronx
country: United States
facility: Chiesi Clinical Trial - Site 840626
state: New York
city: Bronx
country: United States
facility: Chiesi Clinical Trial - Site 840604
state: New York
city: Buffalo
country: United States
facility: Chiesi Clinical Trial - Site 840667
state: New York
city: New Windsor
country: United States
facility: Chiesi Clinical Trial - Site 840678
state: New York
city: New York
country: United States
facility: Chiesi Clinical Trial - Site 840520
state: New York
city: New York
country: United States
facility: Chiesi Clinical Trial - Site 840705
state: New York
city: Charlotte
country: United States
facility: Chiesi Clinical Trial - Site 840664
state: North Carolina
city: Charlotte
country: United States
facility: Chiesi Clinical Trial - Site 840721
state: North Carolina
city: Denver
country: United States
facility: Chiesi Clinical Trial - Site 840610
state: North Carolina
city: Gastonia
country: United States
facility: Chiesi Clinical Trial - Site 840659
state: North Carolina
city: Huntersville
country: United States
facility: Chiesi Clinical Trial - Site 840540
state: North Carolina
city: New Bern
country: United States
facility: Chiesi Clinical Trial - Site 840523
state: North Carolina
city: Shelby
country: United States
facility: Chiesi Clinical Trial - Site 840708
state: North Carolina
city: Winston-Salem
country: United States
facility: Chiesi Clinical Trial - Site 840621
state: North Carolina
city: Cincinnati
country: United States
facility: Chiesi Clinical Trial - Site 840627
state: Ohio
city: Columbus
country: United States
facility: Chiesi Clinical Trial - Site 840713
state: Ohio
city: Dayton
country: United States
facility: Chiesi Clinical Trial - Site 840647
state: Ohio
city: Toledo
country: United States
facility: Chiesi Clinical Trial - Site 840646
state: Ohio
city: Oklahoma City
country: United States
facility: Chiesi Clinical Trial - Site 840668
state: Oklahoma
city: Tulsa
country: United States
facility: Chiesi Clinical Trial - Site 840692
state: Oklahoma
city: Philadelphia
country: United States
facility: Chiesi Clinical Trial - Site 840671
state: Pennsylvania
city: Philadelphia
country: United States
facility: Chiesi Clinical Trial - Site 840683
state: Pennsylvania
city: Anderson
country: United States
facility: Chiesi Clinical Trial - Site 840578
state: South Carolina
city: Charleston
country: United States
facility: Chiesi Clinical Trial - Site 840592
state: South Carolina
city: Fort Mill
country: United States
facility: Chiesi Clinical Trial - Site 840528
state: South Carolina
city: North Charleston
country: United States
facility: Chiesi Clinical Trial - Site 840598
state: South Carolina
city: Rock Hill
country: United States
facility: Chiesi Clinical Trial - Site 840696
state: South Carolina
city: Franklin
country: United States
facility: Chiesi Clinical Trial - Site 840660
state: Tennessee
city: Franklin
country: United States
facility: Chiesi Clinical Trial - Site 840546
state: Tennessee
city: Knoxville
country: United States
facility: Chiesi Clinical Trial - Site 840553
state: Tennessee
city: Baytown
country: United States
facility: Chiesi Clinical Trial - Site 840535
state: Texas
city: Boerne
country: United States
facility: Chiesi Clinical Trial - Site 840634
state: Texas
city: Carrollton
country: United States
facility: Chiesi Clinical Trial - Site 840704
state: Texas
city: Cypress
country: United States
facility: Chiesi Clinical Trial - Site 840566
state: Texas
city: Dallas
country: United States
facility: Chiesi Clinical Trial - Site 840706
state: Texas
city: Houston
country: United States
facility: Chiesi Clinical Trial - Site 840716
state: Texas
city: Houston
country: United States
facility: Chiesi Clinical Trial - Site 840698
state: Texas
city: Kerrville
country: United States
facility: Chiesi Clinical Trial - Site 840574
state: Texas
city: McKinney
country: United States
facility: Chiesi Clinical Trial - Site 840551
state: Texas
city: Mesquite
country: United States
facility: Chiesi Clinical Trial - Site 840575
state: Texas
city: North Richland Hills
country: United States
facility: Chiesi Clinical Trial - Site 840741
state: Texas
city: Pearland
country: United States
facility: Chiesi Clinical Trial - Site 840663
state: Texas
city: Plano
country: United States
facility: Chiesi Clinical Trial - Site 840609
state: Texas
city: San Antonio
country: United States
facility: Chiesi Clinical Trial - Site 840673
state: Texas
city: San Antonio
country: United States
facility: Chiesi Clinical Trial - Site 840681
state: Texas
city: San Antonio
country: United States
facility: Chiesi Clinical Trial - Site 840711
state: Texas
city: San Antonio
country: United States
facility: Chiesi Clinical Trial - Site 840729
state: Texas
city: San Antonio
country: United States
facility: Chiesi Clinical Trial - Site 840597
state: Texas
city: Sherman
country: United States
facility: Chiesi Clinical Trial - Site 840600
state: Texas
city: Sugar Land
country: United States
facility: Chiesi Clinical Trial - Site 840552
state: Texas
city: Tomball
country: United States
facility: Chiesi Clinical Trial - Site 840526
state: Texas
city: Portsmouth
country: United States
facility: Chiesi Clinical Trial - Site 840693
state: Virginia
city: Everett
country: United States
facility: Chiesi Clinical Trial - Site 840709
state: Washington
city: Morgantown
country: United States
facility: Chiesi Clinical Trial - Site 840562
state: West Virginia
city: Greenfield
country: United States
facility: Chiesi Clinical Trial - Site 840532
state: Wisconsin
city: Milwaukee
country: United States
facility: Chiesi Clinical Trial - Site 840723
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Chiesi Clinical Trial - Site 32502
city: Buenos Aires
country: Argentina
facility: Chiesi Clinical Trial - Site 32515
city: Buenos Aires
country: Argentina
facility: Chiesi Clinical Trial - Site 32565
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Chiesi Clinical Trial - Site 32514
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Chiesi Clinical Trial - Site 32567
city: Ciudad autónoma de Buenos Aires
country: Argentina
facility: Chiesi Clinical Trial - Site 32510
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: Chiesi Clinical Trial - Site 32507
city: Concepción Del Uruguay
country: Argentina
facility: Chiesi Clinical Trial - Site 32563
city: Córdoba
country: Argentina
facility: Chiesi Clinical Trial - Site 32503
city: Córdoba
country: Argentina
facility: Chiesi Clinical Trial - Site 32509
city: Florencio Varela
country: Argentina
facility: Chiesi Clinical Trial - Site 32508
city: Florida
country: Argentina
facility: Chiesi Clinical Trial - Site 32501
city: Mar Del Plata
country: Argentina
facility: Chiesi Clinical Trial - Site 32562
city: Mendoza
country: Argentina
facility: Chiesi Clinical Trial - Site 32505
city: Mendoza
country: Argentina
facility: Chiesi Clinical Trial - Site 32511
city: Mendoza
country: Argentina
facility: Chiesi Clinical Trial - Site 32513
city: Quilmes
country: Argentina
facility: Chiesi Clinical Trial - Site 32506
city: Rosario
country: Argentina
facility: Chiesi Clinical Trial - Site 32553
city: San Miguel De Tucumán
country: Argentina
facility: Chiesi Clinical Trial - Site 32512
city: San Miguel De Tucumán
country: Argentina
facility: Chiesi Clinical Trial - Site 32551
city: San Miguel de Tucumán
country: Argentina
facility: Chiesi Clinical Trial - Site 32561
city: San Miguel De Tucumán
country: Argentina
facility: Chiesi Clinical Trial - Site 32564
city: San Rafael
country: Argentina
facility: Chiesi Clinical Trial - Site 32566
city: Santa Fe
country: Argentina
facility: Chiesi Clinical Trial - Site 32556
city: Feldbach
country: Austria
facility: Chiesi Clinical Trial - Site 40502
city: Grieskirchen
country: Austria
facility: Chiesi Clinical Trial - Site 40504
city: Linz
country: Austria
facility: Chiesi Clinical Trial - Site 40501
city: Linz
country: Austria
facility: Chiesi Clinical Trial - Site 40503
city: Wels
country: Austria
facility: Chiesi Clinical Trial - Site 40505
city: Banja Luka
country: Bosnia and Herzegovina
facility: Chiesi Clinical Trial - Site 70553
city: Bihać
country: Bosnia and Herzegovina
facility: Chiesi Clinical Trial - Site 70555
city: Bijeljina
country: Bosnia and Herzegovina
facility: Chiesi Clinical Trial - Site 70554
city: Foča
country: Bosnia and Herzegovina
facility: Chiesi Clinical Trial - Site 70557
city: Gradiška
country: Bosnia and Herzegovina
facility: Chiesi Clinical Trial - Site 70556
city: Mostar
country: Bosnia and Herzegovina
facility: Chiesi Clinical Trial - Site 70560
city: Mostar
country: Bosnia and Herzegovina
facility: Chiesi Clinical Trial - Site 70562
city: Sarajevo
country: Bosnia and Herzegovina
facility: Chiesi Clinical Trial - Site 70559
city: Sarajevo
country: Bosnia and Herzegovina
facility: Chiesi Clinical Trial - Site 70561
city: Travnik
country: Bosnia and Herzegovina
facility: Chiesi Clinical Trial - Site 70551
city: Trebinje
country: Bosnia and Herzegovina
facility: Chiesi Clinical Trial - Site 70558
city: Tuzla
country: Bosnia and Herzegovina
facility: Chiesi Clinical Trial - Site 70563
city: Zenica
country: Bosnia and Herzegovina
facility: Chiesi Clinical Trial - Site 70552
city: Blagoevgrad
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100535
city: Dimitrovgrad
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100534
city: Gabrovo
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100525
city: Haskovo
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100523
city: Kozloduy
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100533
city: Lovech
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100527
city: Montana
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100515
city: Pernik
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100532
city: Pleven
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100522
city: Plovdiv
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100529
city: Razgrad
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100537
city: Ruse
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100512
city: Ruse
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100516
city: Sevlievo
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100536
city: Sofia
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100501
city: Sofia
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100509
city: Sofia
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100514
city: Sofia
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100517
city: Sofia
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100518
city: Sofia
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100530
city: Sofia
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100531
city: Sofia
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100538
city: Stara Zagora
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100524
city: Vidin
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100519
city: Vidin
country: Bulgaria
facility: Chiesi Clinical Trial - Site 100557
city: Concepcion
country: Chile
facility: Chiesi Clinical Trial - Site 152506
city: Quillota
country: Chile
facility: Chiesi Clinical Trial - Site 152507
city: Santiago
country: Chile
facility: Chiesi Clinical Trial - Site 152503
city: Santiago
country: Chile
facility: Chiesi Clinical Trial - Site 152504
city: Santiago
country: Chile
facility: Chiesi Clinical Trial - Site 152508
city: Talca
country: Chile
facility: Chiesi Clinical Trial - Site 152509
city: Valparaiso
country: Chile
facility: Chiesi Clinical Trial - Site 152501
city: Dubrovnik
country: Croatia
facility: Chiesi Clinical Trial - Site 191562
city: Karlovac
country: Croatia
facility: Chiesi Clinical Trial - Site 191552
city: Osijek
country: Croatia
facility: Chiesi Clinical Trial - Site 191557
city: Rijeka
country: Croatia
facility: Chiesi Clinical Trial - Site 191561
city: Rijeka
country: Croatia
facility: Chiesi Clinical Trial - Site 191563
city: Sisak
country: Croatia
facility: Chiesi Clinical Trial - Site 191553
city: Split
country: Croatia
facility: Chiesi Clinical Trial - Site 191558
city: Zadar
country: Croatia
facility: Chiesi Clinical Trial - Site 191555
city: Zagreb
country: Croatia
facility: Chiesi Clinical Trial - Site 191551
city: Zagreb
country: Croatia
facility: Chiesi Clinical Trial - Site 191554
city: Zagreb
country: Croatia
facility: Chiesi Clinical Trial - Site 191556
city: Zagreb
country: Croatia
facility: Chiesi Clinical Trial - Site 191559
city: Zagreb
country: Croatia
facility: Chiesi Clinical Trial - Site 191560
city: Brandýs Nad Labem
country: Czechia
facility: Chiesi Clinical Trial - Site 203551
city: Havlíčkův Brod
country: Czechia
facility: Chiesi Clinical Trial - Site 203518
city: Jindřichův Hradec
country: Czechia
facility: Chiesi Clinical Trial - Site 203501
city: Miroslav
country: Czechia
facility: Chiesi Clinical Trial - Site 203504
city: Mladá Boleslav
country: Czechia
facility: Chiesi Clinical Trial - Site 203516
city: Měšice
country: Czechia
facility: Chiesi Clinical Trial - Site 203517
city: Praha
country: Czechia
facility: Chiesi Clinical Trial - Site 203505
city: Praha
country: Czechia
facility: Chiesi Clinical Trial - Site 203507
city: Praha
country: Czechia
facility: Chiesi Clinical Trial - Site 203513
city: Praha
country: Czechia
facility: Chiesi Clinical Trial - Site 203515
city: Narva
country: Estonia
facility: Chiesi Clinical Trial - Site 372553
city: Tallinn
country: Estonia
facility: Chiesi Clinical Trial - Site 372551
city: Tartu
country: Estonia
facility: Chiesi Clinical Trial - Site 372552
city: Berlin
country: Germany
facility: Chiesi Clinical Trial - Site 276505
city: Berlin
country: Germany
facility: Chiesi Clinical Trial - Site 276506
city: Berlin
country: Germany
facility: Chiesi Clinical Trial - Site 276510
city: Berlin
country: Germany
facility: Chiesi Clinical Trial - Site 276511
city: Berlin
country: Germany
facility: Chiesi Clinical Trial - Site 276515
city: Cottbus
country: Germany
facility: Chiesi Clinical Trial - Site 276556
city: Darmstadt
country: Germany
facility: Chiesi Clinical Trial - Site 276509
city: Delitzsch
country: Germany
facility: Chiesi Clinical Trial - Site 276503
city: Frankfurt Am Main
country: Germany
facility: Chiesi Clinical Trial - Site 276504
city: Geesthacht
country: Germany
facility: Chiesi Clinical Trial - Site 276557
city: Hamburg
country: Germany
facility: Chiesi Clinical Trial - Site 276501
city: Hamburg
country: Germany
facility: Chiesi Clinical Trial - Site 276513
city: Hamburg
country: Germany
facility: Chiesi Clinical Trial - Site 276514
city: Hannover
country: Germany
facility: Chiesi Clinical Trial - Site 276558
city: Koblenz
country: Germany
facility: Chiesi Clinical Trial - Site 276517
city: Leipzig
country: Germany
facility: Chiesi Clinical Trial - Site 276502
city: Leipzig
country: Germany
facility: Chiesi Clinical Trial - Site 276516
city: Leipzig
country: Germany
facility: Chiesi Clinical Trial - Site 276551
city: Mainz
country: Germany
facility: Chiesi Clinical Trial - Site 276507
city: Munich
country: Germany
facility: Chiesi Clinical Trial - Site 276508
city: Peine
country: Germany
facility: Chiesi Clinical Trial - Site 276518
city: Athens
country: Greece
facility: Chiesi Clinical Trial - Site 300506
city: Chortiátis
country: Greece
facility: Chiesi Clinical Trial - Site 300504
city: Heraklion
country: Greece
facility: Chiesi Clinical Trial - Site 300501
city: Ioannina
country: Greece
facility: Chiesi Clinical Trial - Site 300503
city: Thessaloníki
country: Greece
facility: Chiesi Clinical Trial - Site 300505
city: Volos
country: Greece
facility: Chiesi Clinical Trial - Site 300507
city: Balassagyarmat
country: Hungary
facility: Chiesi Clinical Trial - Site 348506
city: Budapest
country: Hungary
facility: Chiesi Clinical Trial - Site 348501
city: Csorna
country: Hungary
facility: Chiesi Clinical Trial - Site 348505
city: Edelény
country: Hungary
facility: Chiesi Clinical Trial - Site 348512
city: Gödöllő
country: Hungary
facility: Chiesi Clinical Trial - Site 348508
city: Monor
country: Hungary
facility: Chiesi Clinical Trial - Site 348509
city: Nyíregyháza
country: Hungary
facility: Chiesi Clinical Trial - Site 348507
city: Pécs
country: Hungary
facility: Chiesi Clinical Trial - Site 348513
city: Sellye
country: Hungary
facility: Chiesi Clinical Trial - Site 348552
city: Szeged
country: Hungary
facility: Chiesi Clinical Trial - Site 348510
city: Szombathely
country: Hungary
facility: Chiesi Clinical Trial - Site 348503
city: Törökbálint
country: Hungary
facility: Chiesi Clinical Trial - Site 348515
city: Ashkelon
country: Israel
facility: Chiesi Clinical Trial - Site 376502
city: Be'er Sheva
country: Israel
facility: Chiesi Clinical Trial - Site 376501
city: Hadera
country: Israel
facility: Chiesi Clinical Trial - Site 376511
city: Haifa
country: Israel
facility: Chiesi Clinical Trial - Site 376508
city: Haifa
country: Israel
facility: Chiesi Clinical Trial - Site 376510
city: Jerusalem
country: Israel
facility: Chiesi Clinical Trial - Site 376503
city: Jerusalem
country: Israel
facility: Chiesi Clinical Trial - Site 376506
city: Kfar Saba
country: Israel
facility: Chiesi Clinical Trial - Site 376507
city: Ramat Gan
country: Israel
facility: Chiesi Clinical Trial - Site 376504
city: Tel Aviv
country: Israel
facility: Chiesi Clinical Trial - Site 376509
city: Anyang-si
country: Korea, Republic of
facility: Chiesi Clinical Trial - Site 408556
city: Daegu
country: Korea, Republic of
facility: Chiesi Clinical Trial - Site 408551
city: Dongjak
country: Korea, Republic of
facility: Chiesi Clinical Trial - Site 408560
city: Gwangju
country: Korea, Republic of
facility: Chiesi Clinical Trial - Site 408554
city: Haeundae
country: Korea, Republic of
facility: Chiesi Clinical Trial - Site 408559
city: Incheon
country: Korea, Republic of
facility: Chiesi Clinical Trial - Site 408557
city: Incheon
country: Korea, Republic of
facility: Chiesi Clinical Trial - Site 408558
city: Jeonju
country: Korea, Republic of
facility: Chiesi Clinical Trial - Site 408555
city: Seoul
country: Korea, Republic of
facility: Chiesi Clinical Trial - Site 408552
city: Seoul
country: Korea, Republic of
facility: Chiesi Clinical Trial - Site 408553
city: Suwon,Gyeonggi-do
country: Korea, Republic of
facility: Chiesi Clinical Trial - Site 408561
city: Balvi
country: Latvia
facility: Chiesi Clinical Trial - Site 371557
city: Daugavpils
country: Latvia
facility: Chiesi Clinical Trial - Site 371553
city: Daugavpils
country: Latvia
facility: Chiesi Clinical Trial - Site 371554
city: Jūrmala
country: Latvia
facility: Chiesi Clinical Trial - Site 371555
city: Riga
country: Latvia
facility: Chiesi Clinical Trial - Site 371551
city: Riga
country: Latvia
facility: Chiesi Clinical Trial - Site 371552
city: Rēzekne
country: Latvia
facility: Chiesi Clinical Trial - Site 371558
city: Rīga
country: Latvia
facility: Chiesi Clinical Trial - Site 371556
city: Chihuahua
country: Mexico
facility: Chiesi Clinical Trial - Site 484502
city: Chihuahua
country: Mexico
facility: Chiesi Clinical Trial - Site 484510
city: Cordoba
country: Mexico
facility: Chiesi Clinical Trial - Site 484505
city: Cuauhtémoc
country: Mexico
facility: Chiesi Clinical Trial - Site 484506
city: Guadalajara
country: Mexico
facility: Chiesi Clinical Trial - Site 484501
city: Guadalajara
country: Mexico
facility: Chiesi Clinical Trial - Site 484507
city: Guadalajara
country: Mexico
facility: Chiesi Clinical Trial - Site 484509
city: Monterrey
country: Mexico
facility: Chiesi Clinical Trial - Site 484503
city: Monterrey
country: Mexico
facility: Chiesi Clinical Trial - Site 484511
city: Veracruz
country: Mexico
facility: Chiesi Clinical Trial - Site 484504
city: Beek
country: Netherlands
facility: Chiesi Clinical Trial - Site 528501
city: Breda
country: Netherlands
facility: Chiesi Clinical Trial - Site 528504
city: Heerlen
country: Netherlands
facility: Chiesi Clinical Trial - Site 528502
city: Leeuwarden
country: Netherlands
facility: Chiesi Clinical Trial - Site 528505
city: Christchurch
country: New Zealand
facility: Chiesi Clinical Trial - Site 554504
city: Hamilton
country: New Zealand
facility: Chiesi Clinical Trial - Site 554502
city: Tauranga
country: New Zealand
facility: Chiesi Clinical Trial - Site 554503
city: Bitola
country: North Macedonia
facility: Chiesi Clinical Trial - Site 807555
city: Gevgelija
country: North Macedonia
facility: Chiesi Clinical Trial - Site 807559
city: Ohrid
country: North Macedonia
facility: Chiesi Clinical Trial - Site 807557
city: Shtip
country: North Macedonia
facility: Chiesi Clinical Trial - Site 807553
city: Skopje
country: North Macedonia
facility: Chiesi Clinical Trial - Site 807552
city: Skopje
country: North Macedonia
facility: Chiesi Clinical Trial - Site 807554
city: Skopje
country: North Macedonia
facility: Chiesi Clinical Trial - Site 807556
city: Bialystok
country: Poland
facility: Chiesi Clinical Trial - Site 616518
city: Giżycko
country: Poland
facility: Chiesi Clinical Trial - Site 616504
city: Katowice
country: Poland
facility: Chiesi Clinical Trial - Site 616515
city: Katowice
country: Poland
facility: Chiesi Clinical Trial - Site 616522
city: Krakow
country: Poland
facility: Chiesi Clinical Trial - Site 616514
city: Kraków
country: Poland
facility: Chiesi Clinical Trial - Site 616509
city: Kraków
country: Poland
facility: Chiesi Clinical Trial - Site 616511
city: Ostrowiec Świętokrzyski
country: Poland
facility: Chiesi Clinical Trial - Site 616519
city: Poznań
country: Poland
facility: Chiesi Clinical Trial - Site 616506
city: Poznań
country: Poland
facility: Chiesi Clinical Trial - Site 616508
city: Sosnowiec
country: Poland
facility: Chiesi Clinical Trial - Site 616501
city: Torun
country: Poland
facility: Chiesi Clinical Trial - Site 616502
city: Wrocław
country: Poland
facility: Chiesi Clinical Trial - Site 616554
city: Łódź
country: Poland
facility: Chiesi Clinical Trial - Site 616503
city: Łódź
country: Poland
facility: Chiesi Clinical Trial - Site 616523
city: Bacău
country: Romania
facility: Chiesi Clinical Trial - Site 642510
city: Braşov
country: Romania
facility: Chiesi Clinical Trial - Site 642551
city: Cluj-Napoca Cluj
country: Romania
facility: Chiesi Clinical Trial - Site 642506
city: Cluj-Napoca Cluj
country: Romania
facility: Chiesi Clinical Trial - Site 642508
city: Cluj-Napoca
country: Romania
facility: Chiesi Clinical Trial - Site 642502
city: Cluj-Napoca
country: Romania
facility: Chiesi Clinical Trial - Site 642504
city: Cluj-Napoca
country: Romania
facility: Chiesi Clinical Trial - Site 642554
city: Cluj
country: Romania
facility: Chiesi Clinical Trial - Site 642512
city: Constanţa
country: Romania
facility: Chiesi Clinical Trial - Site 642501
city: Craiova
country: Romania
facility: Chiesi Clinical Trial - Site 642509
city: Craiova
country: Romania
facility: Chiesi Clinical Trial - Site 642511
city: Iaşi
country: Romania
facility: Chiesi Clinical Trial - Site 642514
city: Oradea
country: Romania
facility: Chiesi Clinical Trial - Site 642503
city: Resca
country: Romania
facility: Chiesi Clinical Trial - Site 642513
city: Timisoara
country: Romania
facility: Chiesi Clinical Trial - Site 642507
city: Timisoara
country: Romania
facility: Chiesi Clinical Trial - Site 642515
city: Timişoara
country: Romania
facility: Chiesi Clinical Trial - Site 642505
city: Kazan
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643517
city: Moscow
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643513
city: Moscow
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643528
city: Nizhniy Novgorod
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643516
city: Odintsovskiy
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643503
city: Saint Petersburg
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643505
city: Saint Petersburg
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643506
city: Saint Petersburg
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643508
city: Saint Petersburg
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643511
city: Saint Petersburg
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643514
city: Saint Petersburg
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643519
city: Saint Petersburg
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643531
city: Saint-Petersburg
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643510
city: Saint-Petersburg
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643512
city: Saint-Petersburg
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643520
city: Sankt-Peterburg
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643504
city: Saratov
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643515
city: Saratov
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643525
city: Ulyanovsk
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643521
city: Voronezh
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643502
city: Vsevolozhsk
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643524
city: Yaroslavl
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643507
city: Yaroslavl
country: Russian Federation
facility: Chiesi Clinical Trial - Site 643518
city: Belgrade
country: Serbia
facility: Chiesi Clinical Trial - Site 688552
city: Belgrade
country: Serbia
facility: Chiesi Clinical Trial - Site 688553
city: Belgrade
country: Serbia
facility: Chiesi Clinical Trial - Site 688555
city: Belgrade
country: Serbia
facility: Chiesi Clinical Trial - Site 688557
city: Belgrade
country: Serbia
facility: Chiesi Clinical Trial - Site 688558
city: Belgrade
country: Serbia
facility: Chiesi Clinical Trial - Site 688559
city: Belgrade
country: Serbia
facility: Chiesi Clinical Trial - Site 688561
city: Belgrade
country: Serbia
facility: Chiesi Clinical Trial - Site 688569
city: Jagodina
country: Serbia
facility: Chiesi Clinical Trial - Site 688570
city: Kragujevac
country: Serbia
facility: Chiesi Clinical Trial - Site 688556
city: Leskovac
country: Serbia
facility: Chiesi Clinical Trial - Site 688562
city: Niš
country: Serbia
facility: Chiesi Clinical Trial - Site 688554
city: Niš
country: Serbia
facility: Chiesi Clinical Trial - Site 688568
city: Pančevo
country: Serbia
facility: Chiesi Clinical Trial - Site 688567
city: Paraćin
country: Serbia
facility: Chiesi Clinical Trial - Site 688560
city: Sombor
country: Serbia
facility: Chiesi Clinical Trial - Site 688551
city: Sremska Kamenica
country: Serbia
facility: Chiesi Clinical Trial - Site 688564
city: Sremska Kamenica
country: Serbia
facility: Chiesi Clinical Trial - Site 688566
city: Sremska Mitrovica
country: Serbia
facility: Chiesi Clinical Trial - Site 688571
city: Užice
country: Serbia
facility: Chiesi Clinical Trial - Site 688563
city: Valjevo
country: Serbia
facility: Chiesi Clinical Trial - Site 688565
city: Bardejov
country: Slovakia
facility: Chiesi Clinical Trial - Site 703501
city: Košice
country: Slovakia
facility: Chiesi Clinical Trial - Site 703503
city: Spišská Nová Ves
country: Slovakia
facility: Chiesi Clinical Trial - Site 703502
city: Barcelona
country: Spain
facility: Chiesi Clinical Trial - Site 724503
city: Cordoba
country: Spain
facility: Chiesi Clinical Trial - Site 724501
city: Madrid
country: Spain
facility: Chiesi Clinical Trial - Site 724505
city: Madrid
country: Spain
facility: Chiesi Clinical Trial - Site 724551
city: Majadahonda
country: Spain
facility: Chiesi Clinical Trial - Site 724504
city: Zaragoza
country: Spain
facility: Chiesi Clinical Trial - Site 724502
city: Adana
country: Turkey
facility: Chiesi Clinical Trial - Site 792512
city: Bornova
country: Turkey
facility: Chiesi Clinical Trial - Site 792510
city: Istanbul
country: Turkey
facility: Chiesi Clinical Trial - Site 792507
city: Kocaeli
country: Turkey
facility: Chiesi Clinical Trial - Site 792514
city: Mersin
country: Turkey
facility: Chiesi Clinical Trial - Site 792513
city: Pamukkale
country: Turkey
facility: Chiesi Clinical Trial - Site 792506
city: Pendik
country: Turkey
facility: Chiesi Clinical Trial - Site 792508
city: Yenişehir
country: Turkey
facility: Chiesi Clinical Trial - Site 792511
city: Çanakkale
country: Turkey
facility: Chiesi Clinical Trial - Site 792551
city: Dnipro
country: Ukraine
facility: Chiesi Clinical Trial - Site 804522
city: Ivano-Frankivs'k
country: Ukraine
facility: Chiesi Clinical Trial - Site 804502
city: Kharkiv
country: Ukraine
facility: Chiesi Clinical Trial - Site 804504
city: Kharkiv
country: Ukraine
facility: Chiesi Clinical Trial - Site 804506
city: Kharkiv
country: Ukraine
facility: Chiesi Clinical Trial - Site 804509
city: Kharkov
country: Ukraine
facility: Chiesi Clinical Trial - Site 804505
city: Kherson
country: Ukraine
facility: Chiesi Clinical Trial - Site 804503
city: Kiev
country: Ukraine
facility: Chiesi Clinical Trial - Site 804511
city: Kremenchuk
country: Ukraine
facility: Chiesi Clinical Trial - Site 804520
city: Kyiv
country: Ukraine
facility: Chiesi Clinical Trial - Site 804501
city: Kyiv
country: Ukraine
facility: Chiesi Clinical Trial - Site 804508
city: Kyiv
country: Ukraine
facility: Chiesi Clinical Trial - Site 804512
city: Kyiv
country: Ukraine
facility: Chiesi Clinical Trial - Site 804516
city: Kyiv
country: Ukraine
facility: Chiesi Clinical Trial - Site 804518
city: Kyiv
country: Ukraine
facility: Chiesi Clinical Trial - Site 804521
city: Odessa
country: Ukraine
facility: Chiesi Clinical Trial - Site 804527
city: Poltava
country: Ukraine
facility: Chiesi Clinical Trial - Site 804507
city: Vinnytsia
country: Ukraine
facility: Chiesi Clinical Trial - Site 804515
city: Vinnytsia
country: Ukraine
facility: Chiesi Clinical Trial - Site 804517
city: Zaporizhia
country: Ukraine
facility: Chiesi Clinical Trial - Site 804528
city: Belfast
country: United Kingdom
facility: Chiesi Clinical Trial - Site 826510
city: Bradford
country: United Kingdom
facility: Chiesi Clinical Trial - Site 826509
city: London
country: United Kingdom
facility: Chiesi Clinical Trial - Site 826511
city: Rochdale
country: United Kingdom
facility: Chiesi Clinical Trial - Site 826512
Study officials:
affiliation: Weill Cornell Medical College, New York Presbyterian Hospital, 1305 York avenue box 96 NY 10021 USA
name: Fernando J. MARTINEZ, Prof.
role: PRINCIPAL_INVESTIGATOR
References: