AzTrials
AzTrials

Chronic Obstructive Pulmonary DiseasePhase 3PILLARNCT04636814

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)

A Phase 3 study testing CHF6001 1600µg, CHF6001 3200µg and Roflumilast in people with Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 460 sites in 28 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
CHF6001 1600µg, CHF6001 3200µg and Roflumilast
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,973 participants
Where
460 sitesin 28 countries
Study dates
12 Jul 2021to 23 Dec 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

460 sites in 28 countries.

460 sites in 28 countries

United States150 sites

  • Chiesi Clinical Trial - Site 840542

    Adairsville, Georgia, 30103-2438

  • Chiesi Clinical Trial - Site 840635

    Andalusia, Alabama, 36420-5310

  • Chiesi Clinical Trial - Site 840578

    Anderson, South Carolina, 29621-4822

  • Chiesi Clinical Trial - Site 840645

    Annapolis, Maryland, 21401

  • Chiesi Clinical Trial - Site 840661

    Baltimore, Maryland, 21224-6821

  • Chiesi Clinical Trial - Site 840722

    Bayonne, New Jersey, 07002

  • Chiesi Clinical Trial - Site 840535

    Baytown, Texas, 77521-2416

  • Chiesi Clinical Trial - Site 840634

    Boerne, Texas, 78006-1993

  • Chiesi Clinical Trial - Site 840735

    Brooksville, Florida, 34613

  • Chiesi Clinical Trial - Site 840667

    Buffalo, New York, 14203-1070

  • Chiesi Clinical Trial - Site 840704

    Carrollton, Texas, 14000

  • Chiesi Clinical Trial - Site 840636

    Centennial, Colorado, 80112-1406

  • Chiesi Clinical Trial - Site 840592

    Charleston, South Carolina, 29412-2625

  • Chiesi Clinical Trial - Site 840664

    Charlotte, North Carolina, 28210-0106

  • Chiesi Clinical Trial - Site 840721

    Charlotte, North Carolina, 28273

  • Chiesi Clinical Trial - Site 840513

    Chiefland, Florida, 32626

  • Chiesi Clinical Trial - Site 840627

    Cincinnati, Ohio, 45236

  • Chiesi Clinical Trial - Site 840652

    Clearwater, Florida, 33756

  • Chiesi Clinical Trial - Site 840569

    Clearwater, Florida, 33765-2103

  • Chiesi Clinical Trial - Site 840728

    College Park, Georgia, 30349

  • Chiesi Clinical Trial - Site 840717

    Columbus, Georgia, 31904

  • Chiesi Clinical Trial - Site 840713

    Columbus, Ohio, 43228

  • Chiesi Clinical Trial - Site 840684

    Conway, Arkansas, 72032

  • Chiesi Clinical Trial - Site 840545

    Coral Gables, Florida, 33135

  • Chiesi Clinical Trial - Site 840710

    Cordele, Georgia, 31015

  • Chiesi Clinical Trial - Site 840603

    Cutler Bay, Florida, 33144-2566

  • Chiesi Clinical Trial - Site 840587

    Cutler Bay, Florida, 33189-1230

  • Chiesi Clinical Trial - Site 840568

    Cutler Bay, Florida, 33189

  • Chiesi Clinical Trial - Site 840566

    Cypress, Texas, 77429-4696

  • Chiesi Clinical Trial - Site 840706

    Dallas, Texas, 75246

  • Chiesi Clinical Trial - Site 840647

    Dayton, Ohio, 45419-4336

  • Chiesi Clinical Trial - Site840539

    Daytona Beach, Florida, 33470-9216

  • Chiesi Clinical Trial - Site 840554

    DeBary, Florida, 32713-2260

  • Chiesi Clinical Trial - Site 840610

    Denver, North Carolina, 28037-7930

  • Chiesi Clinical Trial - Site 840625

    Doral, Florida, 33014-2426

  • Chiesi Clinical Trial - Site 840572

    Doral, Florida, 33122-1902

  • Chiesi Clinical Trial - Site 840689

    East Point, Georgia, 30344

  • Chiesi Clinical Trial - Site 840709

    Everett, Washington, 98208

  • Chiesi Clinical Trial - Site 840614

    Foley, Alabama, 36535-2248

  • Chiesi Clinical Trial - Site 840528

    Fort Mill, South Carolina, 29701

  • Chiesi Clinical Trial - Site 840660

    Franklin, Tennessee, 37067

  • Chiesi Clinical Trial - Site 840546

    Franklin, Tennessee, 38305

  • Chiesi Clinical Trial - Site 840659

    Gastonia, North Carolina, 28054-7481

  • Chiesi Clinical Trial - Site 840532

    Greenfield, Wisconsin, 53228-3467

  • Chiesi Clinical Trial - Site 840670

    Guntersville, Alabama, 35976-2206

  • Chiesi Clinical Trial - Site 840703

    Henderson, Nevada, 89052

  • Chiesi Clinical Trial - Site 840685

    Hialeah, Florida, 33010-4103

  • Chiesi Clinical Trial - Site 840504

    Hialeah, Florida, 33012-3618

  • Chiesi Clinical Trial - Site 840639

    Hialeah, Florida, 33015-2952

  • Chiesi Clinical Trial - Site 840582

    Hialeah, Florida, 33015-6003

  • Chiesi Clinical Trial - Site 840617

    Hialeah, Florida, 33016-2753

  • Chiesi Clinical Trial - Site 840514

    Hialeah, Florida, 33186-5331

  • Chiesi Clinical Trial - Site 840637

    Hialeah Gardens, Florida, 33016

  • Chiesi Clinical Trial - Site 840509

    Hollywood, Florida, 33021

  • Chiesi Clinical Trial - Site 840730

    Hollywood, Florida, 33024

  • Chiesi Clinical Trial - Site 840565

    Homestead, Florida, 33256

  • Chiesi Clinical Trial - Site 840716

    Houston, Texas, 77008

  • Chiesi Clinical Trial - Site 840698

    Houston, Texas, 77030

  • Chiesi Clinical Trial - Site 840540

    Huntersville, North Carolina, 28078-5082

  • Chiesi Clinical Trial - Site 840574

    Kerrville, Texas, 78028-9640

  • Chiesi Clinical Trial - Site 840553

    Knoxville, Tennessee, 37909-1161

  • Chiesi Clinical Trial - Site 840675

    Laguna Hills, California, 92653-5509

  • Chiesi Clinical Trial - Site 840688

    Lakewood, Colorado, 80228

  • Chiesi Clinical Trial - Site 840529

    Las Vegas, Nevada, 89106-4159

  • Chiesi Clinical Trial - Site 840666

    Los Angeles, California, 90017-5649

  • Chiesi Clinical Trial - Site 840674

    Loxahatchee Groves, Florida, 33470

  • Chiesi Clinical Trial - Site 840551

    McKinney, Texas, 75069

  • Chiesi Clinical Trial - Site 840732

    Melbourne, Florida, 32934

  • Chiesi Clinical Trial - Site 840575

    Mesquite, Texas, 75149-2438

  • Chiesi Clinical Trial - Site 840624

    Miami, Florida, 33125-5114

  • Chiesi Clinical Trial - Site 840596

    Miami, Florida, 33126-1921

  • Chiesi Clinical Trial - Site 840556

    Miami, Florida, 33126-1926

  • Chiesi Clinical Trial - Site 840602

    Miami, Florida, 33135-2967

  • Chiesi Clinical Trial - Site 840507

    Miami, Florida, 33144-2100

  • Chiesi Clinical Trial - Site 840519

    Miami, Florida, 33144-4273

  • Chiesi Clinical Trial - Site 840505

    Miami, Florida, 33144-5037

  • Chiesi Clinical Trial - Site 840644

    Miami, Florida, 33144

  • Chiesi Clinical Trial - Site 840557

    Miami, Florida, 33155-1694

  • Chiesi Clinical Trial - Site 840588

    Miami, Florida, 33155-4630

  • Chiesi Clinical Trial - Site 840618

    Miami, Florida, 33155-6538

  • Chiesi Clinical Trial - Site 840525

    Miami, Florida, 33155-6541

  • Chiesi Clinical Trial - Site 840656

    Miami, Florida, 33155-6542

  • Chiesi Clinical Trial - Site 840622

    Miami, Florida, 33155

  • Chiesi Clinical Trial - Site 840537

    Miami, Florida, 33165-2075

  • Chiesi Clinical Trial - Site 840691

    Miami, Florida, 33165-2470

  • Chiesi Clinical Trial - Site 840503

    Miami, Florida, 33175-3598

  • Chiesi Clinical Trial - Site 840694

    Miami, Florida, 33184-1176

  • Chiesi Clinical Trial - Site 840630

    Miami, Florida, 33185

  • Chiesi Clinical Trial - Site 840506

    Miami Gardens, Florida, 33014-6426

  • Chiesi Clinical Trial - Site 840608

    Miami Lakes, Florida, 33014-2425

  • Chiesi Clinical Trial - Site 840720

    Mobile, Alabama, 36608

  • Chiesi Clinical Trial - Site 840562

    Morgantown, West Virginia, 26505-0423

  • Chiesi Clinical Trial - Site 840724

    Muncie, Indiana, 46303

  • Chiesi Clinical Trial - Site 840523

    New Bern, North Carolina, 28562-5238

  • Chiesi Clinical Trial - Site 840678

    New Windsor, New York, 12553-7754

  • Chiesi Clinical Trial - Site 840520

    New York, New York, 10021-0005

  • Chiesi Clinical Trial - Site 840705

    New York, New York, 10029-6500

  • Chiesi Clinical Trial - Site 840511

    Newport Beach, California, 92663-3661

  • Chiesi Clinical Trial - Site 840598

    North Charleston, South Carolina, 29420

  • Chiesi Clinical Trial - Site 840707

    North Dartmouth, Massachusetts, 02747-1271

  • Chiesi Clinical Trial - Site 840701

    North Las Vegas, Nevada, 89030-7193

  • Chiesi Clinical Trial - Site 840741

    North Richland Hills, Texas, 76180-7319

  • Chiesi Clinical Trial - Site 840680

    Northridge, California, 91324-6200

  • Chiesi Clinical Trial - Site 840605

    Northridge, California, 91324

  • Chiesi Clinical Trial - Site 840668

    Oklahoma City, Oklahoma, 73104

  • Chiesi Clinical Trial - Site 840686

    Omaha, Nebraska, 68178

  • Chiesi Clinical Trial - Site 840524

    Orlando, Florida, 32807-3555

  • Chiesi Clinical Trial - Site 840563

    Orlando, Florida, 32825

  • Chiesi Clinical Trial - Site 840663

    Pearland, Texas, 77584-7401

  • Chiesi Clinical Trial - Site 840702

    Pembroke Pines, Florida, 14000

  • Chiesi Clinical Trial - Site 840502

    Pembroke Pines, Florida, 33024-3618

  • Chiesi Clinical Trial - Site 840550

    Pembroke Pines, Florida, 33024-6442

  • Chiesi Clinical Trial - Site 840671

    Philadelphia, Pennsylvania, 19107-5109

  • Chiesi Clinical Trial - Site 840683

    Philadelphia, Pennsylvania, 19140

  • Chiesi Clinical Trial - Site 840638

    Phoenix, Arizona, 85018-5434

  • Chiesi Clinical Trial - Site 840609

    Plano, Texas, 75025

  • Chiesi Clinical Trial - Site 840700

    Pomona, California, 91768

  • Chiesi Clinical Trial - Site 840527

    Pompano Beach, Florida, 33064-3547

  • Chiesi Clinical Trial - Site 840658

    Port Gibson, Mississippi, 39150

  • Chiesi Clinical Trial - Site 840693

    Portsmouth, Virginia, 23703

  • Chiesi Clinical Trial - Site 840696

    Rock Hill, South Carolina, 29732-1160

  • Chiesi Clinical Trial - Site 840641

    Saint Charles, Missouri, 63301-2835

  • Chiesi Clinical Trial - Site 840673

    San Antonio, Texas, 78215-1528

  • Chiesi Clinical Trial - Site 840681

    San Antonio, Texas, 78229

  • Chiesi Clinical Trial - Site 840711

    San Antonio, Texas, 78229

  • Chiesi Clinical Trial - Site 840729

    San Antonio, Texas, 78229

  • Chiesi Clinical Trial - Site 840597

    San Antonio, Texas, 78258

  • Chiesi Clinical Trial - Site 840643

    Saraland, Alabama, 36571-3014

  • Chiesi Clinical Trial - Site 840708

    Shelby, North Carolina, 28150

  • Chiesi Clinical Trial - Site 840600

    Sherman, Texas, 75092-7351

  • Chiesi Clinical Trial - Site 840654

    South Miami, Florida, 33143-4960

  • Chiesi Clinical Trial - Site 840714

    St Louis, Missouri, 63110

  • Chiesi Clinical Trial - Site 840541

    St Louis, Missouri, 63141

  • Chiesi Clinical Trial - Site 840669

    St Louis, Missouri, 63141

  • Chiesi Clinical Trial - Site 840699

    St. Petersburg, Florida, 33707-6129

  • Chiesi Clinical Trial - Site 840697

    St. Petersburg, Florida, 33713-8900

  • Chiesi Clinical Trial - Site 840726

    Stonecrest, Georgia, 30038

  • Chiesi Clinical Trial - Site 840552

    Sugar Land, Texas, 77479-3481

  • Chiesi Clinical Trial - Site 840567

    Tampa, Florida, 33613-3740

  • Chiesi Clinical Trial - Site 840626

    The Bronx, New York, 10455

  • Chiesi Clinical Trial - Site 840604

    The Bronx, New York, 10468-6401

  • Chiesi Clinical Trial - Site 840646

    Toledo, Ohio, 43617-1178

  • Chiesi Clinical Trial - Site 840526

    Tomball, Texas, 77373

  • Chiesi Clinical Trial - Site 840657

    Troy, Michigan, 48085

  • Chiesi Clinical Trial - Site 840692

    Tulsa, Oklahoma, 74133-5829

  • Chiesi Clinical Trial - Site 840564

    Valdosta, Georgia, 31605-1096

  • Chiesi Clinical Trial - Site 840531

    Westminster, California, 92708

  • Chiesi Clinical Trial - Site 840621

    Winston-Salem, North Carolina, 27103

  • Chiesi Clinical Trial - Site 840632

    Winter Park, Florida, 32789

  • Chiesi Clinical Trial - Site 840672

    Zachary, Louisiana, 70791-4010

Other trials in United States

Bulgaria25 sites

  • Chiesi Clinical Trial - Site 100535

    Blagoevgrad

  • Chiesi Clinical Trial - Site 100534

    Dimitrovgrad

  • Chiesi Clinical Trial - Site 100525

    Gabrovo

  • Chiesi Clinical Trial - Site 100523

    Haskovo

  • Chiesi Clinical Trial - Site 100533

    Kozloduy

  • Chiesi Clinical Trial - Site 100527

    Lovech

  • Chiesi Clinical Trial - Site 100515

    Montana

  • Chiesi Clinical Trial - Site 100532

    Pernik

  • Chiesi Clinical Trial - Site 100522

    Pleven

  • Chiesi Clinical Trial - Site 100529

    Plovdiv

  • Chiesi Clinical Trial - Site 100537

    Razgrad

  • Chiesi Clinical Trial - Site 100512

    Rousse

  • Chiesi Clinical Trial - Site 100516

    Rousse

  • Chiesi Clinical Trial - Site 100536

    Sevlievo

  • Chiesi Clinical Trial - Site 100501

    Sofia

  • Chiesi Clinical Trial - Site 100509

    Sofia

  • Chiesi Clinical Trial - Site 100514

    Sofia

  • Chiesi Clinical Trial - Site 100517

    Sofia

  • Chiesi Clinical Trial - Site 100518

    Sofia

  • Chiesi Clinical Trial - Site 100530

    Sofia

  • Chiesi Clinical Trial - Site 100531

    Sofia

  • Chiesi Clinical Trial - Site 100538

    Sofia

  • Chiesi Clinical Trial - Site 100524

    Stara Zagora

  • Chiesi Clinical Trial - Site 100519

    Vidin

  • Chiesi Clinical Trial - Site 100557

    Vidin

Other trials in Bulgaria

Argentina24 sites

  • Chiesi Clinical Trial - Site 32502

    Buenos Aires

  • Chiesi Clinical Trial - Site 32510

    Buenos Aires

  • Chiesi Clinical Trial - Site 32515

    Buenos Aires

  • Chiesi Clinical Trial - Site 32565

    Buenos Aires

  • Chiesi Clinical Trial - Site 32514

    Ciudad Autonoma Buenos Aires

  • Chiesi Clinical Trial - Site 32567

    Ciudad Autonoma Buenos Aires

  • Chiesi Clinical Trial - Site 32507

    Ciudad Autónoma de Buenos Aire

  • Chiesi Clinical Trial - Site 32563

    Concepción del Uruguay

  • Chiesi Clinical Trial - Site 32503

    Córdoba

  • Chiesi Clinical Trial - Site 32509

    Córdoba

  • Chiesi Clinical Trial - Site 32501

    Florida

  • Chiesi Clinical Trial - Site 32562

    Mar del Plata

  • Chiesi Clinical Trial - Site 32505

    Mendoza

  • Chiesi Clinical Trial - Site 32511

    Mendoza

  • Chiesi Clinical Trial - Site 32513

    Mendoza

  • Chiesi Clinical Trial - Site 32506

    Quilmes

  • Chiesi Clinical Trial - Site 32553

    Rosario

  • Chiesi Clinical Trial - Site 32508

    San Juan Bautista

  • Chiesi Clinical Trial - Site 32512

    San Miguel de Tucumán

  • Chiesi Clinical Trial - Site 32551

    San Miguel de Tucumán

  • Chiesi Clinical Trial - Site 32561

    San Miguel de Tucumán

  • Chiesi Clinical Trial - Site 32564

    San Miguel de Tucumán

  • Chiesi Clinical Trial - Site 32566

    San Rafael

  • Chiesi Clinical Trial - Site 32556

    Santa Fe

Other trials in Argentina

Russia23 sites

  • Chiesi Clinical Trial - Site 643517

    Kazan'

  • Chiesi Clinical Trial - Site 643513

    Moscow

  • Chiesi Clinical Trial - Site 643528

    Moscow

  • Chiesi Clinical Trial - Site 643516

    Nizhny Novgorod

  • Chiesi Clinical Trial - Site 643503

    Odintsovskiy

  • Chiesi Clinical Trial - Site 643504

    Saint Petersburg

  • Chiesi Clinical Trial - Site 643505

    Saint Petersburg

  • Chiesi Clinical Trial - Site 643506

    Saint Petersburg

  • Chiesi Clinical Trial - Site 643508

    Saint Petersburg

  • Chiesi Clinical Trial - Site 643510

    Saint Petersburg

  • Chiesi Clinical Trial - Site 643511

    Saint Petersburg

  • Chiesi Clinical Trial - Site 643512

    Saint Petersburg

  • Chiesi Clinical Trial - Site 643514

    Saint Petersburg

  • Chiesi Clinical Trial - Site 643519

    Saint Petersburg

  • Chiesi Clinical Trial - Site 643520

    Saint Petersburg

  • Chiesi Clinical Trial - Site 643531

    Saint Petersburg

  • Chiesi Clinical Trial - Site 643515

    Saratov

  • Chiesi Clinical Trial - Site 643525

    Saratov

  • Chiesi Clinical Trial - Site 643521

    Ulyanovsk

  • Chiesi Clinical Trial - Site 643502

    Voronezh

  • Chiesi Clinical Trial - Site 643524

    Vsevolozhsk

  • Chiesi Clinical Trial - Site 643507

    Yaroslavl

  • Chiesi Clinical Trial - Site 643518

    Yaroslavl

Other trials in Russia

Germany21 sites

  • Chiesi Clinical Trial - Site 276505

    Berlin

  • Chiesi Clinical Trial - Site 276506

    Berlin

  • Chiesi Clinical Trial - Site 276510

    Berlin

  • Chiesi Clinical Trial - Site 276511

    Berlin

  • Chiesi Clinical Trial - Site 276515

    Berlin

  • Chiesi Clinical Trial - Site 276556

    Cottbus

  • Chiesi Clinical Trial - Site 276509

    Darmstadt

  • Chiesi Clinical Trial - Site 276503

    Delitzsch

  • Chiesi Clinical Trial - Site 276504

    Frankfurt am Main

  • Chiesi Clinical Trial - Site 276557

    Geesthacht

  • Chiesi Clinical Trial - Site 276501

    Hamburg

  • Chiesi Clinical Trial - Site 276513

    Hamburg

  • Chiesi Clinical Trial - Site 276514

    Hamburg

  • Chiesi Clinical Trial - Site 276558

    Hanover

  • Chiesi Clinical Trial - Site 276517

    Koblenz

  • Chiesi Clinical Trial - Site 276502

    Leipzig

  • Chiesi Clinical Trial - Site 276516

    Leipzig

  • Chiesi Clinical Trial - Site 276551

    Leipzig

  • Chiesi Clinical Trial - Site 276507

    Mainz

  • Chiesi Clinical Trial - Site 276508

    Munich

  • Chiesi Clinical Trial - Site 276518

    Peine

Other trials in Germany

Serbia21 sites

  • Chiesi Clinical Trial - Site 688552

    Belgrade

  • Chiesi Clinical Trial - Site 688553

    Belgrade

  • Chiesi Clinical Trial - Site 688555

    Belgrade

  • Chiesi Clinical Trial - Site 688557

    Belgrade

  • Chiesi Clinical Trial - Site 688558

    Belgrade

  • Chiesi Clinical Trial - Site 688559

    Belgrade

  • Chiesi Clinical Trial - Site 688561

    Belgrade

  • Chiesi Clinical Trial - Site 688569

    Belgrade

  • Chiesi Clinical Trial - Site 688570

    Jagodina

  • Chiesi Clinical Trial - Site 688564

    Kamenitz

  • Chiesi Clinical Trial - Site 688566

    Kamenitz

  • Chiesi Clinical Trial - Site 688556

    Kragujevac

  • Chiesi Clinical Trial - Site 688562

    Leskovac

  • Chiesi Clinical Trial - Site 688554

    Niš

  • Chiesi Clinical Trial - Site 688568

    Niš

  • Chiesi Clinical Trial - Site 688567

    Pančevo

  • Chiesi Clinical Trial - Site 688560

    Paraćin

  • Chiesi Clinical Trial - Site 688551

    Sombor

  • Chiesi Clinical Trial - Site 688571

    Sremska Mitrovica

  • Chiesi Clinical Trial - Site 688563

    Užice

  • Chiesi Clinical Trial - Site 688565

    Valjevo

Other trials in Serbia

Ukraine20 sites

  • Chiesi Clinical Trial - Site 804522

    Dnipro

  • Chiesi Clinical Trial - Site 804502

    Ivano-Frankivsk

  • Chiesi Clinical Trial - Site 804504

    Kharkiv

  • Chiesi Clinical Trial - Site 804505

    Kharkiv

  • Chiesi Clinical Trial - Site 804506

    Kharkiv

  • Chiesi Clinical Trial - Site 804509

    Kharkiv

  • Chiesi Clinical Trial - Site 804503

    Kherson

  • Chiesi Clinical Trial - Site 804511

    Kiev

  • Chiesi Clinical Trial - Site 804520

    Kremenchuk

  • Chiesi Clinical Trial - Site 804501

    Kyiv

  • Chiesi Clinical Trial - Site 804508

    Kyiv

  • Chiesi Clinical Trial - Site 804512

    Kyiv

  • Chiesi Clinical Trial - Site 804516

    Kyiv

  • Chiesi Clinical Trial - Site 804518

    Kyiv

  • Chiesi Clinical Trial - Site 804521

    Kyiv

  • Chiesi Clinical Trial - Site 804527

    Odesa

  • Chiesi Clinical Trial - Site 804507

    Poltava

  • Chiesi Clinical Trial - Site 804515

    Vinnytsia

  • Chiesi Clinical Trial - Site 804517

    Vinnytsia

  • Chiesi Clinical Trial - Site 804528

    Zaporizhia

Other trials in Ukraine

Romania17 sites

  • Chiesi Clinical Trial - Site 642510

    Bacau

  • Chiesi Clinical Trial - Site 642551

    Brasov

  • Chiesi Clinical Trial - Site 642502

    Cluj-Napoca

  • Chiesi Clinical Trial - Site 642504

    Cluj-Napoca

  • Chiesi Clinical Trial - Site 642512

    Cluj-Napoca

  • Chiesi Clinical Trial - Site 642554

    Cluj-Napoca

  • Chiesi Clinical Trial - Site 642506

    Cluj-Napoca Cluj

  • Chiesi Clinical Trial - Site 642508

    Cluj-Napoca Cluj

  • Chiesi Clinical Trial - Site 642501

    Constanța

  • Chiesi Clinical Trial - Site 642509

    Craiova

  • Chiesi Clinical Trial - Site 642511

    Craiova

  • Chiesi Clinical Trial - Site 642514

    Iași

  • Chiesi Clinical Trial - Site 642503

    Oradea

  • Chiesi Clinical Trial - Site 642513

    Reșca

  • Chiesi Clinical Trial - Site 642505

    Timișoara

  • Chiesi Clinical Trial - Site 642507

    Timișoara

  • Chiesi Clinical Trial - Site 642515

    Timișoara

Other trials in Romania

Poland15 sites

  • Chiesi Clinical Trial - Site 616518

    Bialystok

  • Chiesi Clinical Trial - Site 616504

    Giżycko

  • Chiesi Clinical Trial - Site 616515

    Katowice

  • Chiesi Clinical Trial - Site 616522

    Katowice

  • Chiesi Clinical Trial - Site 616509

    Krakow

  • Chiesi Clinical Trial - Site 616511

    Krakow

  • Chiesi Clinical Trial - Site 616514

    Krakow

  • Chiesi Clinical Trial - Site 616503

    Lodz

  • Chiesi Clinical Trial - Site 616523

    Lodz

  • Chiesi Clinical Trial - Site 616519

    Ostrowiec Świętokrzyski

  • Chiesi Clinical Trial - Site 616506

    Poznan

  • Chiesi Clinical Trial - Site 616508

    Poznan

  • Chiesi Clinical Trial - Site 616501

    Sosnowiec

  • Chiesi Clinical Trial - Site 616502

    Torun

  • Chiesi Clinical Trial - Site 616554

    Wroclaw

Other trials in Poland

Bosnia and Herzegovina13 sites

  • Chiesi Clinical Trial - Site 70553

    Banja Luka

  • Chiesi Clinical Trial - Site 70555

    Bihać

  • Chiesi Clinical Trial - Site 70554

    Bijeljina

  • Chiesi Clinical Trial - Site 70557

    Foca

  • Chiesi Clinical Trial - Site 70556

    Gradiska

  • Chiesi Clinical Trial - Site 70560

    Mostar

  • Chiesi Clinical Trial - Site 70562

    Mostar

  • Chiesi Clinical Trial - Site 70559

    Sarajevo

  • Chiesi Clinical Trial - Site 70561

    Sarajevo

  • Chiesi Clinical Trial - Site 70551

    Travnik

  • Chiesi Clinical Trial - Site 70558

    Trebinje

  • Chiesi Clinical Trial - Site 70563

    Tuzla

  • Chiesi Clinical Trial - Site 70552

    Zenica

Other trials in Bosnia and Herzegovina

Croatia13 sites

  • Chiesi Clinical Trial - Site 191562

    Dubrovnik

  • Chiesi Clinical Trial - Site 191552

    Karlovac

  • Chiesi Clinical Trial - Site 191557

    Osijek

  • Chiesi Clinical Trial - Site 191561

    Rijeka

  • Chiesi Clinical Trial - Site 191563

    Rijeka

  • Chiesi Clinical Trial - Site 191553

    Sisak

  • Chiesi Clinical Trial - Site 191558

    Split

  • Chiesi Clinical Trial - Site 191555

    Zadar

  • Chiesi Clinical Trial - Site 191551

    Zagreb

  • Chiesi Clinical Trial - Site 191554

    Zagreb

  • Chiesi Clinical Trial - Site 191556

    Zagreb

  • Chiesi Clinical Trial - Site 191559

    Zagreb

  • Chiesi Clinical Trial - Site 191560

    Zagreb

Other trials in Croatia

Hungary12 sites

  • Chiesi Clinical Trial - Site 348506

    Balassagyarmat

  • Chiesi Clinical Trial - Site 348501

    Budapest

  • Chiesi Clinical Trial - Site 348505

    Csorna

  • Chiesi Clinical Trial - Site 348512

    Edelény

  • Chiesi Clinical Trial - Site 348508

    Gödöllő

  • Chiesi Clinical Trial - Site 348509

    Monor

  • Chiesi Clinical Trial - Site 348507

    Nyíregyháza

  • Chiesi Clinical Trial - Site 348513

    Pécs

  • Chiesi Clinical Trial - Site 348552

    Sellye

  • Chiesi Clinical Trial - Site 348510

    Szeged

  • Chiesi Clinical Trial - Site 348503

    Szombathely

  • Chiesi Clinical Trial - Site 348515

    Törökbálint

Other trials in Hungary

South Korea11 sites

  • Chiesi Clinical Trial - Site 408556

    Anyang-si

  • Chiesi Clinical Trial - Site 408551

    Daegu

  • Chiesi Clinical Trial - Site 408560

    Dongjak

  • Chiesi Clinical Trial - Site 408554

    Gwangju

  • Chiesi Clinical Trial - Site 408559

    Haeundae

  • Chiesi Clinical Trial - Site 408557

    Incheon

  • Chiesi Clinical Trial - Site 408558

    Incheon

  • Chiesi Clinical Trial - Site 408555

    Jeonju

  • Chiesi Clinical Trial - Site 408552

    Seoul

  • Chiesi Clinical Trial - Site 408553

    Seoul

  • Chiesi Clinical Trial - Site 408561

    Suwon,Gyeonggi-do

Other trials in South Korea

Czechia10 sites

  • Chiesi Clinical Trial - Site 203551

    Brandýs nad Labem

  • Chiesi Clinical Trial - Site 203518

    Havlíčkův Brod

  • Chiesi Clinical Trial - Site 203501

    Jindřichův Hradec

  • Chiesi Clinical Trial - Site 203517

    Měšice

  • Chiesi Clinical Trial - Site 203504

    Miroslav

  • Chiesi Clinical Trial - Site 203516

    Mladá Boleslav

  • Chiesi Clinical Trial - Site 203505

    Prague

  • Chiesi Clinical Trial - Site 203507

    Prague

  • Chiesi Clinical Trial - Site 203513

    Prague

  • Chiesi Clinical Trial - Site 203515

    Prague

Other trials in Czechia

Israel10 sites

  • Chiesi Clinical Trial - Site 376502

    Ashkelon

  • Chiesi Clinical Trial - Site 376501

    Beersheba

  • Chiesi Clinical Trial - Site 376511

    Hadera

  • Chiesi Clinical Trial - Site 376508

    Haifa

  • Chiesi Clinical Trial - Site 376510

    Haifa

  • Chiesi Clinical Trial - Site 376503

    Jerusalem

  • Chiesi Clinical Trial - Site 376506

    Jerusalem

  • Chiesi Clinical Trial - Site 376507

    Kfar Saba

  • Chiesi Clinical Trial - Site 376504

    Ramat Gan

  • Chiesi Clinical Trial - Site 376509

    Tel Aviv

Other trials in Israel

Mexico10 sites

  • Chiesi Clinical Trial - Site 484502

    Chihuahua City

  • Chiesi Clinical Trial - Site 484510

    Chihuahua City

  • Chiesi Clinical Trial - Site 484505

    Córdoba

  • Chiesi Clinical Trial - Site 484506

    Cuauhtémoc

  • Chiesi Clinical Trial - Site 484501

    Guadalajara

  • Chiesi Clinical Trial - Site 484507

    Guadalajara

  • Chiesi Clinical Trial - Site 484509

    Guadalajara

  • Chiesi Clinical Trial - Site 484503

    Monterrey

  • Chiesi Clinical Trial - Site 484511

    Monterrey

  • Chiesi Clinical Trial - Site 484504

    Veracruz

Other trials in Mexico

Turkey (Türkiye)9 sites

  • Chiesi Clinical Trial - Site 792512

    Adana

  • Chiesi Clinical Trial - Site 792510

    Bornova

  • Chiesi Clinical Trial - Site 792551

    Çanakkale

  • Chiesi Clinical Trial - Site 792507

    Istanbul

  • Chiesi Clinical Trial - Site 792514

    Kocaeli

  • Chiesi Clinical Trial - Site 792513

    Mersin

  • Chiesi Clinical Trial - Site 792506

    Pamukkale

  • Chiesi Clinical Trial - Site 792508

    Pendik

  • Chiesi Clinical Trial - Site 792511

    Yenişehir

Other trials in Turkey (Türkiye)

Latvia8 sites

  • Chiesi Clinical Trial - Site 371557

    Balvi

  • Chiesi Clinical Trial - Site 371553

    Daugavpils

  • Chiesi Clinical Trial - Site 371554

    Daugavpils

  • Chiesi Clinical Trial - Site 371555

    Jūrmala

  • Chiesi Clinical Trial - Site 371558

    Rēzekne

  • Chiesi Clinical Trial - Site 371551

    Riga

  • Chiesi Clinical Trial - Site 371552

    Riga

  • Chiesi Clinical Trial - Site 371556

    Riga

Other trials in Latvia

Chile7 sites

  • Chiesi Clinical Trial - Site 152506

    Concepción

  • Chiesi Clinical Trial - Site 152507

    Quillota

  • Chiesi Clinical Trial - Site 152503

    Santiago

  • Chiesi Clinical Trial - Site 152504

    Santiago

  • Chiesi Clinical Trial - Site 152508

    Santiago

  • Chiesi Clinical Trial - Site 152509

    Talca

  • Chiesi Clinical Trial - Site 152501

    Valparaíso

Other trials in Chile

North Macedonia7 sites

  • Chiesi Clinical Trial - Site 807555

    Bitola

  • Chiesi Clinical Trial - Site 807559

    Gevgelija

  • Chiesi Clinical Trial - Site 807557

    Ohrid

  • Chiesi Clinical Trial - Site 807553

    Shtip

  • Chiesi Clinical Trial - Site 807552

    Skopje

  • Chiesi Clinical Trial - Site 807554

    Skopje

  • Chiesi Clinical Trial - Site 807556

    Skopje

Other trials in North Macedonia

Greece6 sites

  • Chiesi Clinical Trial - Site 300506

    Athens

  • Chiesi Clinical Trial - Site 300504

    Chortiatis

  • Chiesi Clinical Trial - Site 300501

    Heraklion

  • Chiesi Clinical Trial - Site 300503

    Ioannina

  • Chiesi Clinical Trial - Site 300505

    Thessaloniki

  • Chiesi Clinical Trial - Site 300507

    Volos

Other trials in Greece

Spain6 sites

  • Chiesi Clinical Trial - Site 724503

    Barcelona

  • Chiesi Clinical Trial - Site 724501

    Córdoba

  • Chiesi Clinical Trial - Site 724505

    Madrid

  • Chiesi Clinical Trial - Site 724551

    Madrid

  • Chiesi Clinical Trial - Site 724504

    Majadahonda

  • Chiesi Clinical Trial - Site 724502

    Zaragoza

Other trials in Spain

Austria5 sites

  • Chiesi Clinical Trial - Site 40502

    Feldbach

  • Chiesi Clinical Trial - Site 40504

    Grieskirchen

  • Chiesi Clinical Trial - Site 40501

    Linz

  • Chiesi Clinical Trial - Site 40503

    Linz

  • Chiesi Clinical Trial - Site 40505

    Wels

Other trials in Austria

Netherlands4 sites

  • Chiesi Clinical Trial - Site 528501

    Beek

  • Chiesi Clinical Trial - Site 528504

    Breda

  • Chiesi Clinical Trial - Site 528502

    Heerlen

  • Chiesi Clinical Trial - Site 528505

    Leeuwarden

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United Kingdom4 sites

  • Chiesi Clinical Trial - Site 826510

    Belfast

  • Chiesi Clinical Trial - Site 826509

    Bradford

  • Chiesi Clinical Trial - Site 826511

    London

  • Chiesi Clinical Trial - Site 826512

    Rochdale

Other trials in United Kingdom

Estonia3 sites

  • Chiesi Clinical Trial - Site 372553

    Narva

  • Chiesi Clinical Trial - Site 372551

    Tallinn

  • Chiesi Clinical Trial - Site 372552

    Tartu

Other trials in Estonia

New Zealand3 sites

  • Chiesi Clinical Trial - Site 554504

    Christchurch

  • Chiesi Clinical Trial - Site 554502

    Hamilton

  • Chiesi Clinical Trial - Site 554503

    Tauranga

Other trials in New Zealand

Slovakia3 sites

  • Chiesi Clinical Trial - Site 703501

    Bardejov

  • Chiesi Clinical Trial - Site 703503

    Košice

  • Chiesi Clinical Trial - Site 703502

    Spišská Nová Ves

Other trials in Slovakia

About this study

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.

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.

Being tested
CHF6001 1600µg, CHF6001 3200µg, Placebo, Roflumilast
Keywords
COPD, chronic bronchitis, PDE4 inhibitor, anti-inflammatory respiratory drug, Tanimilast
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CHF6001 1600µgDrug

    CHF6001 400µg, 2 inhalations bid (total daily dose of 1600µg) and Roflumilast matching placebo, 1 tablet once daily

  • CHF6001 3200µgDrug

    CHF6001 800µg, 2 inhalations bid (total daily dose of 3200µg) and Roflumilast matching placebo, 1 tablet once daily

  • PlaceboDrug

    CHF6001 matching placebo, 2 inhalations bid and Roflumilast matching placebo, 1 tablet once daily

  • RoflumilastDrug

    • 1 tablet of Roflumilast (Daliresp®), 250µg, once daily during the first 4 weeks of treatment then 1 tablet of Roflumilast (Daliresp®), 500µg, once daily for the remaining treatment period and CHF6001 matching placebo, 2 inhalations bid
Study groups in NCT04636814
Study groupRoleWhat they receive
CHF6001 1600µgExperimentalNot described
Receives: Drug: CHF6001 1600µg
CHF6001 3200µgExperimentalNot described
Receives: Drug: CHF6001 3200µg
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
RoflumilastActive comparatorNot described
Receives: Drug: Roflumilast

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The number of moderate and severe exacerbations occurring during the planned 52-week treatment period.

    Moderate or severe exacerbation is defined by symptomatic worsening of COPD:

    • Moderate : requiring use of systemic corticosteroids (oral/IV/IM corticosteroids), and/or use of antibiotics
    • Severe : requiring hospitalisation or resulting in death

    Measured: Up to 52 weeks

Secondary outcomes (15)

  1. The time to first moderate or severe exacerbation.

    The time to first moderate or severe exacerbation.

    Measured: Up to 52 weeks

  2. The annual rate of severe exacerbations.

    The annual rate of severe exacerbations.

    Measured: Up to 52 weeks

  3. The time to first severe exacerbation.

    The time to first severe exacerbation.

    Measured: Up to 52 weeks

  4. The number of all on-treatment severe exacerbations.

    The number of all on-treatment severe exacerbations.

    Measured: Up to 52 weeks

  5. The number of all on-treatment exacerbations requiring systemic corticosteroids.

    The number of all on-treatment exacerbations requiring systemic corticosteroids.

    Measured: Up to 52 weeks

  6. Change from baseline (pre-dose Visit 2) in pre-dose FEV1, at week 52.

    Change from baseline (pre-dose Visit 2) in pre-dose FEV1, at week 52.

    Measured: At week 52

  7. Change from baseline in Saint Georges Respiratory Questionnaire (SGRQ) total and domain scores at week 52.

    Change from baseline in Saint Georges Respiratory Questionnaire (SGRQ) total and domain scores at week 52.

    Measured: At week 52

  8. Saint Georges Respiratory Questionnaire response (SGRQ) (change from baseline SGRQ total score ≤ -4) at week 52.

    Saint Georges Respiratory Questionnaire response (SGRQ) (change from baseline SGRQ total score ≤ -4) at week 52.

    Measured: At week 52

  9. Change from baseline to last inter-visit period (week 40-52) in EXACT-Respiratory Symptoms (E-RS) Total and subscale scores.

    Change from baseline to last inter-visit period (week 40-52) in EXACT-Respiratory Symptoms (E-RS) Total and subscale scores.

    Measured: Up to 52 weeks

  10. E-RS response (change from baseline E-RS Total score ≤ -2) at week 52.

    E-RS response (change from baseline E-RS Total score ≤ -2) at week 52.

    Measured: At week 52

  11. Change from baseline to last inter-visit period (week 40-52) in the percentage of days without intake of rescue medication and in the average rescue medication use (number of puffs).

    Change from baseline to last inter-visit period (week 40-52) in the percentage of days

    Measured: Up to 52 weeks

  12. Time to study medication discontinuation for any reason.

    Time to study medication discontinuation for any reason.

    Measured: Up to 52 weeks

  13. Time to moderate or severe exacerbation or study medication discontinuation due to any adverse event, lack of efficacy or death (composite endpoint) and time to study medication discontinuation component.

    Time to moderate or severe exacerbation or study medication discontinuation due to any adverse event, lack of efficacy or death (composite endpoint) and time to study medication discontinuation component.

    Measured: Up to 52 weeks

  14. Time to first moderate/severe exacerbation or study medication discontinuation due to any class-related AE, lack of efficacy, or death (composite endpoint) and time to study medication discontinuation component.

    Time to first moderate/severe exacerbation or study medication discontinuation due to any class-related AE, lack of efficacy, or death (composite endpoint) and time to study medication discontinuation component.

    Measured: Up to 52 weeks

  15. Key Secondary Variable: Change from baseline in SGRQ Total score at week 52

    Key Secondary Variable: Change from baseline in SGRQ Total score at week 52

    Measured: At week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2020
  2. Study start12 Jul 2021
  3. Primary completion23 Dec 2025
  4. Study completion23 Dec 2025

Why it stopped: Strategic decision by Sponsor; not due to safety reasons

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
3,973 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04636814
Sponsor's protocol ID
CLI-06001AA1-05
Other IDs
2020-003648-97, 2023-510174-13-00, 2023
Acronym
PILLAR
Status last verified
Jan 2026
First submitted
16 Nov 2020
Last updated
2 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CHF6001 1600µg, CHF6001 3200µg and Roflumilast in people with Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 460 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 460 sites in United States, Bulgaria, Argentina, Russia, Germany and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Strategic decision by Sponsor; not due to safety reasons). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of moderate and severe exacerbations occurring during the planned 52-week treatment period. (time frame: Up to 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04636814.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.

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