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)

NCT04636814 | Terminated Phase 3 DMC FDA Drug

• 3 other identifiers: CLI-06001AA1-052020-003648-972023-510174-13-00
• Study Type: interventional
• Target: 3,973
• Locations: 27 countries
• Sites: 454

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; chronic bronchitis; PDE4 inhibitor; anti-inflammatory respiratory drug; Tanimilast

Outcome Measures

Primary Outcomes (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

  Up to 52 weeks

Secondary Outcomes (15)

• The time to first moderate or severe exacerbation.

  Up to 52 weeks

• The annual rate of severe exacerbations.

  Up to 52 weeks

• The time to first severe exacerbation.

  Up to 52 weeks

• The number of all on-treatment severe exacerbations.

  Up to 52 weeks

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

  Up to 52 weeks

Study Arms (4)

CHF6001 1600µg

EXPERIMENTAL

Drug: CHF6001 1600µg

CHF6001 3200µg

EXPERIMENTAL

Drug: CHF6001 3200µg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Roflumilast

ACTIVE COMPARATOR

Drug: Roflumilast

Interventions

CHF6001 3200µg DRUG

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

CHF6001 3200µg

Placebo DRUG

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

Placebo

Roflumilast DRUG

\- 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

Roflumilast

CHF6001 1600µg DRUG

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

CHF6001 1600µg

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (460)

Chiesi Clinical Trial - Site 840635

Andalusia, Alabama, 36420-5310, United States

Location

Chiesi Clinical Trial - Site 840614

Foley, Alabama, 36535-2248, United States

Location

Chiesi Clinical Trial - Site 840670

Guntersville, Alabama, 35976-2206, United States

Location

Chiesi Clinical Trial - Site 840720

Mobile, Alabama, 36608, United States

Location

Chiesi Clinical Trial - Site 840643

Saraland, Alabama, 36571-3014, United States

Location

Chiesi Clinical Trial - Site 840638

Phoenix, Arizona, 85018-5434, United States

Location

Chiesi Clinical Trial - Site 840684

Conway, Arkansas, 72032, United States

Location

Chiesi Clinical Trial - Site 840675

Laguna Hills, California, 92653-5509, United States

Location

Chiesi Clinical Trial - Site 840666

Los Angeles, California, 90017-5649, United States

Location

Chiesi Clinical Trial - Site 840511

Newport Beach, California, 92663-3661, United States

Location

Chiesi Clinical Trial - Site 840680

Northridge, California, 91324-6200, United States

Location

Chiesi Clinical Trial - Site 840605

Northridge, California, 91324, United States

Location

Chiesi Clinical Trial - Site 840700

Pomona, California, 91768, United States

Location

Chiesi Clinical Trial - Site 840531

Westminster, California, 92708, United States

Location

Chiesi Clinical Trial - Site 840636

Centennial, Colorado, 80112-1406, United States

Location

Chiesi Clinical Trial - Site 840688

Lakewood, Colorado, 80228, United States

Location

Chiesi Clinical Trial - Site 840735

Brooksville, Florida, 34613, United States

Location

Chiesi Clinical Trial - Site 840513

Chiefland, Florida, 32626, United States

Location

Chiesi Clinical Trial - Site 840652

Clearwater, Florida, 33756, United States

Location

Chiesi Clinical Trial - Site 840569

Clearwater, Florida, 33765-2103, United States

Location

Chiesi Clinical Trial - Site 840545

Coral Gables, Florida, 33135, United States

Location

Chiesi Clinical Trial - Site 840603

Cutler Bay, Florida, 33144-2566, United States

Location

Chiesi Clinical Trial - Site 840587

Cutler Bay, Florida, 33189-1230, United States

Location

Chiesi Clinical Trial - Site 840568

Cutler Bay, Florida, 33189, United States

Location

Chiesi Clinical Trial - Site840539

Daytona Beach, Florida, 33470-9216, United States

Location

Chiesi Clinical Trial - Site 840554

DeBary, Florida, 32713-2260, United States

Location

Chiesi Clinical Trial - Site 840625

Doral, Florida, 33014-2426, United States

Location

Chiesi Clinical Trial - Site 840572

Doral, Florida, 33122-1902, United States

Location

Chiesi Clinical Trial - Site 840685

Hialeah, Florida, 33010-4103, United States

Location

Chiesi Clinical Trial - Site 840504

Hialeah, Florida, 33012-3618, United States

Location

Chiesi Clinical Trial - Site 840639

Hialeah, Florida, 33015-2952, United States

Location

Chiesi Clinical Trial - Site 840582

Hialeah, Florida, 33015-6003, United States

Location

Chiesi Clinical Trial - Site 840617

Hialeah, Florida, 33016-2753, United States

Location

Chiesi Clinical Trial - Site 840514

Hialeah, Florida, 33186-5331, United States

Location

Chiesi Clinical Trial - Site 840637

Hialeah Gardens, Florida, 33016, United States

Location

Chiesi Clinical Trial - Site 840509

Hollywood, Florida, 33021, United States

Location

Chiesi Clinical Trial - Site 840730

Hollywood, Florida, 33024, United States

Location

Chiesi Clinical Trial - Site 840565

Homestead, Florida, 33256, United States

Location

Chiesi Clinical Trial - Site 840674

Loxahatchee Groves, Florida, 33470, United States

Location

Chiesi Clinical Trial - Site 840732

Melbourne, Florida, 32934, United States

Location

Chiesi Clinical Trial - Site 840624

Miami, Florida, 33125-5114, United States

Location

Chiesi Clinical Trial - Site 840596

Miami, Florida, 33126-1921, United States

Location

Chiesi Clinical Trial - Site 840556

Miami, Florida, 33126-1926, United States

Location

Chiesi Clinical Trial - Site 840602

Miami, Florida, 33135-2967, United States

Location

Chiesi Clinical Trial - Site 840507

Miami, Florida, 33144-2100, United States

Location

Chiesi Clinical Trial - Site 840519

Miami, Florida, 33144-4273, United States

Location

Chiesi Clinical Trial - Site 840505

Miami, Florida, 33144-5037, United States

Location

Chiesi Clinical Trial - Site 840644

Miami, Florida, 33144, United States

Location

Chiesi Clinical Trial - Site 840557

Miami, Florida, 33155-1694, United States

Location

Chiesi Clinical Trial - Site 840588

Miami, Florida, 33155-4630, United States

Location

Chiesi Clinical Trial - Site 840618

Miami, Florida, 33155-6538, United States

Location

Chiesi Clinical Trial - Site 840525

Miami, Florida, 33155-6541, United States

Location

Chiesi Clinical Trial - Site 840656

Miami, Florida, 33155-6542, United States

Location

Chiesi Clinical Trial - Site 840622

Miami, Florida, 33155, United States

Location

Chiesi Clinical Trial - Site 840537

Miami, Florida, 33165-2075, United States

Location

Chiesi Clinical Trial - Site 840691

Miami, Florida, 33165-2470, United States

Location

Chiesi Clinical Trial - Site 840503

Miami, Florida, 33175-3598, United States

Location

Chiesi Clinical Trial - Site 840694

Miami, Florida, 33184-1176, United States

Location

Chiesi Clinical Trial - Site 840630

Miami, Florida, 33185, United States

Location

Chiesi Clinical Trial - Site 840506

Miami Gardens, Florida, 33014-6426, United States

Location

Chiesi Clinical Trial - Site 840608

Miami Lakes, Florida, 33014-2425, United States

Location

Chiesi Clinical Trial - Site 840524

Orlando, Florida, 32807-3555, United States

Location

Chiesi Clinical Trial - Site 840563

Orlando, Florida, 32825, United States

Location

Chiesi Clinical Trial - Site 840702

Pembroke Pines, Florida, 14000, United States

Location

Chiesi Clinical Trial - Site 840502

Pembroke Pines, Florida, 33024-3618, United States

Location

Chiesi Clinical Trial - Site 840550

Pembroke Pines, Florida, 33024-6442, United States

Location

Chiesi Clinical Trial - Site 840527

Pompano Beach, Florida, 33064-3547, United States

Location

Chiesi Clinical Trial - Site 840654

South Miami, Florida, 33143-4960, United States

Location

Chiesi Clinical Trial - Site 840699

St. Petersburg, Florida, 33707-6129, United States

Location

Chiesi Clinical Trial - Site 840697

St. Petersburg, Florida, 33713-8900, United States

Location

Chiesi Clinical Trial - Site 840567

Tampa, Florida, 33613-3740, United States

Location

Chiesi Clinical Trial - Site 840632

Winter Park, Florida, 32789, United States

Location

Chiesi Clinical Trial - Site 840542

Adairsville, Georgia, 30103-2438, United States

Location

Chiesi Clinical Trial - Site 840728

College Park, Georgia, 30349, United States

Location

Chiesi Clinical Trial - Site 840717

Columbus, Georgia, 31904, United States

Location

Chiesi Clinical Trial - Site 840710

Cordele, Georgia, 31015, United States

Location

Chiesi Clinical Trial - Site 840689

East Point, Georgia, 30344, United States

Location

Chiesi Clinical Trial - Site 840726

Stonecrest, Georgia, 30038, United States

Location

Chiesi Clinical Trial - Site 840564

Valdosta, Georgia, 31605-1096, United States

Location

Chiesi Clinical Trial - Site 840724

Muncie, Indiana, 46303, United States

Location

Chiesi Clinical Trial - Site 840672

Zachary, Louisiana, 70791-4010, United States

Location

Chiesi Clinical Trial - Site 840645

Annapolis, Maryland, 21401, United States

Location

Chiesi Clinical Trial - Site 840661

Baltimore, Maryland, 21224-6821, United States

Location

Chiesi Clinical Trial - Site 840707

North Dartmouth, Massachusetts, 02747-1271, United States

Location

Chiesi Clinical Trial - Site 840657

Troy, Michigan, 48085, United States

Location

Chiesi Clinical Trial - Site 840658

Port Gibson, Mississippi, 39150, United States

Location

Chiesi Clinical Trial - Site 840641

Saint Charles, Missouri, 63301-2835, United States

Location

Chiesi Clinical Trial - Site 840714

St Louis, Missouri, 63110, United States

Location

Chiesi Clinical Trial - Site 840541

St Louis, Missouri, 63141, United States

Location

Chiesi Clinical Trial - Site 840669

St Louis, Missouri, 63141, United States

Location

Chiesi Clinical Trial - Site 840686

Omaha, Nebraska, 68178, United States

Location

Chiesi Clinical Trial - Site 840703

Henderson, Nevada, 89052, United States

Location

Chiesi Clinical Trial - Site 840529

Las Vegas, Nevada, 89106-4159, United States

Location

Chiesi Clinical Trial - Site 840701

North Las Vegas, Nevada, 89030-7193, United States

Location

Chiesi Clinical Trial - Site 840722

Bayonne, New Jersey, 07002, United States

Location

Chiesi Clinical Trial - Site 840667

Buffalo, New York, 14203-1070, United States

Location

Chiesi Clinical Trial - Site 840678

New Windsor, New York, 12553-7754, United States

Location

Chiesi Clinical Trial - Site 840520

New York, New York, 10021-0005, United States

Location

Chiesi Clinical Trial - Site 840705

New York, New York, 10029-6500, United States

Location

Chiesi Clinical Trial - Site 840626

The Bronx, New York, 10455, United States

Location

Chiesi Clinical Trial - Site 840604

The Bronx, New York, 10468-6401, United States

Location

Chiesi Clinical Trial - Site 840664

Charlotte, North Carolina, 28210-0106, United States

Location

Chiesi Clinical Trial - Site 840721

Charlotte, North Carolina, 28273, United States

Location

Chiesi Clinical Trial - Site 840610

Denver, North Carolina, 28037-7930, United States

Location

Chiesi Clinical Trial - Site 840659

Gastonia, North Carolina, 28054-7481, United States

Location

Chiesi Clinical Trial - Site 840540

Huntersville, North Carolina, 28078-5082, United States

Location

Chiesi Clinical Trial - Site 840523

New Bern, North Carolina, 28562-5238, United States

Location

Chiesi Clinical Trial - Site 840708

Shelby, North Carolina, 28150, United States

Location

Chiesi Clinical Trial - Site 840621

Winston-Salem, North Carolina, 27103, United States

Location

Chiesi Clinical Trial - Site 840627

Cincinnati, Ohio, 45236, United States

Location

Chiesi Clinical Trial - Site 840713

Columbus, Ohio, 43228, United States

Location

Chiesi Clinical Trial - Site 840647

Dayton, Ohio, 45419-4336, United States

Location

Chiesi Clinical Trial - Site 840646

Toledo, Ohio, 43617-1178, United States

Location

Chiesi Clinical Trial - Site 840668

Oklahoma City, Oklahoma, 73104, United States

Location

Chiesi Clinical Trial - Site 840692

Tulsa, Oklahoma, 74133-5829, United States

Location

Chiesi Clinical Trial - Site 840671

Philadelphia, Pennsylvania, 19107-5109, United States

Location

Chiesi Clinical Trial - Site 840683

Philadelphia, Pennsylvania, 19140, United States

Location

Chiesi Clinical Trial - Site 840578

Anderson, South Carolina, 29621-4822, United States

Location

Chiesi Clinical Trial - Site 840592

Charleston, South Carolina, 29412-2625, United States

Location

Chiesi Clinical Trial - Site 840528

Fort Mill, South Carolina, 29701, United States

Location

Chiesi Clinical Trial - Site 840598

North Charleston, South Carolina, 29420, United States

Location

Chiesi Clinical Trial - Site 840696

Rock Hill, South Carolina, 29732-1160, United States

Location

Chiesi Clinical Trial - Site 840660

Franklin, Tennessee, 37067, United States

Location

Chiesi Clinical Trial - Site 840546

Franklin, Tennessee, 38305, United States

Location

Chiesi Clinical Trial - Site 840553

Knoxville, Tennessee, 37909-1161, United States

Location

Chiesi Clinical Trial - Site 840535

Baytown, Texas, 77521-2416, United States

Location

Chiesi Clinical Trial - Site 840634

Boerne, Texas, 78006-1993, United States

Location

Chiesi Clinical Trial - Site 840704

Carrollton, Texas, 14000, United States

Location

Chiesi Clinical Trial - Site 840566

Cypress, Texas, 77429-4696, United States

Location

Chiesi Clinical Trial - Site 840706

Dallas, Texas, 75246, United States

Location

Chiesi Clinical Trial - Site 840716

Houston, Texas, 77008, United States

Location

Chiesi Clinical Trial - Site 840698

Houston, Texas, 77030, United States

Location

Chiesi Clinical Trial - Site 840574

Kerrville, Texas, 78028-9640, United States

Location

Chiesi Clinical Trial - Site 840551

McKinney, Texas, 75069, United States

Location

Chiesi Clinical Trial - Site 840575

Mesquite, Texas, 75149-2438, United States

Location

Chiesi Clinical Trial - Site 840741

North Richland Hills, Texas, 76180-7319, United States

Location

Chiesi Clinical Trial - Site 840663

Pearland, Texas, 77584-7401, United States

Location

Chiesi Clinical Trial - Site 840609

Plano, Texas, 75025, United States

Location

Chiesi Clinical Trial - Site 840673

San Antonio, Texas, 78215-1528, United States

Location

Chiesi Clinical Trial - Site 840681

San Antonio, Texas, 78229, United States

Location

Chiesi Clinical Trial - Site 840711

San Antonio, Texas, 78229, United States

Location

Chiesi Clinical Trial - Site 840729

San Antonio, Texas, 78229, United States

Location

Chiesi Clinical Trial - Site 840597

San Antonio, Texas, 78258, United States

Location

Chiesi Clinical Trial - Site 840600

Sherman, Texas, 75092-7351, United States

Location

Chiesi Clinical Trial - Site 840552

Sugar Land, Texas, 77479-3481, United States

Location

Chiesi Clinical Trial - Site 840526

Tomball, Texas, 77373, United States

Location

Chiesi Clinical Trial - Site 840693

Portsmouth, Virginia, 23703, United States

Location

Chiesi Clinical Trial - Site 840709

Everett, Washington, 98208, United States

Location

Chiesi Clinical Trial - Site 840562

Morgantown, West Virginia, 26505-0423, United States

Location

Chiesi Clinical Trial - Site 840532

Greenfield, Wisconsin, 53228-3467, United States

Location

Chiesi Clinical Trial - Site 32502

Buenos Aires, Argentina

Location

Chiesi Clinical Trial - Site 32510

Buenos Aires, Argentina

Location

Chiesi Clinical Trial - Site 32515

Buenos Aires, Argentina

Location

Chiesi Clinical Trial - Site 32565

Buenos Aires, Argentina

Location

Chiesi Clinical Trial - Site 32514

Ciudad Autonoma Buenos Aires, Argentina

Location

Chiesi Clinical Trial - Site 32567

Ciudad Autonoma Buenos Aires, Argentina

Location

Chiesi Clinical Trial - Site 32507

Ciudad Autónoma de Buenos Aire, Argentina

Location

Chiesi Clinical Trial - Site 32563

Concepción del Uruguay, Argentina

Location

Chiesi Clinical Trial - Site 32503

Córdoba, Argentina

Location

Chiesi Clinical Trial - Site 32509

Córdoba, Argentina

Location

Chiesi Clinical Trial - Site 32501

Florida, Argentina

Location

Chiesi Clinical Trial - Site 32562

Mar del Plata, Argentina

Location

Chiesi Clinical Trial - Site 32505

Mendoza, Argentina

Location

Chiesi Clinical Trial - Site 32511

Mendoza, Argentina

Location

Chiesi Clinical Trial - Site 32513

Mendoza, Argentina

Location

Chiesi Clinical Trial - Site 32506

Quilmes, Argentina

Location

Chiesi Clinical Trial - Site 32553

Rosario, Argentina

Location

Chiesi Clinical Trial - Site 32508

San Juan Bautista, Argentina

Location

Chiesi Clinical Trial - Site 32512

San Miguel de Tucumán, Argentina

Location

Chiesi Clinical Trial - Site 32551

San Miguel de Tucumán, Argentina

Location

Chiesi Clinical Trial - Site 32561

San Miguel de Tucumán, Argentina

Location

Chiesi Clinical Trial - Site 32564

San Miguel de Tucumán, Argentina

Location

Chiesi Clinical Trial - Site 32566

San Rafael, Argentina

Location

Chiesi Clinical Trial - Site 32556

Santa Fe, Argentina

Location

Chiesi Clinical Trial - Site 40502

Feldbach, Austria

Location

Chiesi Clinical Trial - Site 40504

Grieskirchen, Austria

Location

Chiesi Clinical Trial - Site 40501

Linz, Austria

Location

Chiesi Clinical Trial - Site 40503

Linz, Austria

Location

Chiesi Clinical Trial - Site 40505

Wels, Austria

Location

Chiesi Clinical Trial - Site 70553

Banja Luka, Bosnia and Herzegovina

Location

Chiesi Clinical Trial - Site 70555

Bihać, Bosnia and Herzegovina

Location

Chiesi Clinical Trial - Site 70554

Bijeljina, Bosnia and Herzegovina

Location

Chiesi Clinical Trial - Site 70557

Foča, Bosnia and Herzegovina

Location

Chiesi Clinical Trial - Site 70556

Gradiška, Bosnia and Herzegovina

Location

Chiesi Clinical Trial - Site 70560

Mostar, Bosnia and Herzegovina

Location

Chiesi Clinical Trial - Site 70562

Mostar, Bosnia and Herzegovina

Location

Chiesi Clinical Trial - Site 70559

Sarajevo, Bosnia and Herzegovina

Location

Chiesi Clinical Trial - Site 70561

Sarajevo, Bosnia and Herzegovina

Location

Chiesi Clinical Trial - Site 70551

Travnik, Bosnia and Herzegovina

Location

Chiesi Clinical Trial - Site 70558

Trebinje, Bosnia and Herzegovina

Location

Chiesi Clinical Trial - Site 70563

Tuzla, Bosnia and Herzegovina

Location

Chiesi Clinical Trial - Site 70552

Zenica, Bosnia and Herzegovina

Location

Chiesi Clinical Trial - Site 100535

Blagoevgrad, Bulgaria

Location

Chiesi Clinical Trial - Site 100534

Dimitrovgrad, Bulgaria

Location

Chiesi Clinical Trial - Site 100525

Gabrovo, Bulgaria

Location

Chiesi Clinical Trial - Site 100523

Haskovo, Bulgaria

Location

Chiesi Clinical Trial - Site 100533

Kozloduy, Bulgaria

Location

Chiesi Clinical Trial - Site 100527

Lovech, Bulgaria

Location

Chiesi Clinical Trial - Site 100515

Montana, Bulgaria

Location

Chiesi Clinical Trial - Site 100532

Pernik, Bulgaria

Location

Chiesi Clinical Trial - Site 100522

Pleven, Bulgaria

Location

Chiesi Clinical Trial - Site 100529

Plovdiv, Bulgaria

Location

Chiesi Clinical Trial - Site 100537

Razgrad, Bulgaria

Location

Chiesi Clinical Trial - Site 100512

Rousse, Bulgaria

Location

Chiesi Clinical Trial - Site 100516

Rousse, Bulgaria

Location

Chiesi Clinical Trial - Site 100536

Sevlievo, Bulgaria

Location

Chiesi Clinical Trial - Site 100501

Sofia, Bulgaria

Location

Chiesi Clinical Trial - Site 100509

Sofia, Bulgaria

Location

Chiesi Clinical Trial - Site 100514

Sofia, Bulgaria

Location

Chiesi Clinical Trial - Site 100517

Sofia, Bulgaria

Location

Chiesi Clinical Trial - Site 100518

Sofia, Bulgaria

Location

Chiesi Clinical Trial - Site 100530

Sofia, Bulgaria

Location

Chiesi Clinical Trial - Site 100531

Sofia, Bulgaria

Location

Chiesi Clinical Trial - Site 100538

Sofia, Bulgaria

Location

Chiesi Clinical Trial - Site 100524

Stara Zagora, Bulgaria

Location

Chiesi Clinical Trial - Site 100519

Vidin, Bulgaria

Location

Chiesi Clinical Trial - Site 100557

Vidin, Bulgaria

Location

Chiesi Clinical Trial - Site 152506

Concepción, Chile

Location

Chiesi Clinical Trial - Site 152507

Quillota, Chile

Location

Chiesi Clinical Trial - Site 152503

Santiago, Chile

Location

Chiesi Clinical Trial - Site 152504

Santiago, Chile

Location

Chiesi Clinical Trial - Site 152508

Santiago, Chile

Location

Chiesi Clinical Trial - Site 152509

Talca, Chile

Location

Chiesi Clinical Trial - Site 152501

Valparaíso, Chile

Location

Chiesi Clinical Trial - Site 191562

Dubrovnik, Croatia

Location

Chiesi Clinical Trial - Site 191552

Karlovac, Croatia

Location

Chiesi Clinical Trial - Site 191557

Osijek, Croatia

Location

Chiesi Clinical Trial - Site 191561

Rijeka, Croatia

Location

Chiesi Clinical Trial - Site 191563

Rijeka, Croatia

Location

Chiesi Clinical Trial - Site 191553

Sisak, Croatia

Location

Chiesi Clinical Trial - Site 191558

Split, Croatia

Location

Chiesi Clinical Trial - Site 191555

Zadar, Croatia

Location

Chiesi Clinical Trial - Site 191551

Zagreb, Croatia

Location

Chiesi Clinical Trial - Site 191554

Zagreb, Croatia

Location

Chiesi Clinical Trial - Site 191556

Zagreb, Croatia

Location

Chiesi Clinical Trial - Site 191559

Zagreb, Croatia

Location

Chiesi Clinical Trial - Site 191560

Zagreb, Croatia

Location

Chiesi Clinical Trial - Site 203551

Brandýs nad Labem, Czechia

Location

Chiesi Clinical Trial - Site 203518

Havlíčkův Brod, Czechia

Location

Chiesi Clinical Trial - Site 203501

Jindřichův Hradec, Czechia

Location

Chiesi Clinical Trial - Site 203517

Měšice, Czechia

Location

Chiesi Clinical Trial - Site 203504

Miroslav, Czechia

Location

Chiesi Clinical Trial - Site 203516

Mladá Boleslav, Czechia

Location

Chiesi Clinical Trial - Site 203505

Prague, Czechia

Location

Chiesi Clinical Trial - Site 203507

Prague, Czechia

Location

Chiesi Clinical Trial - Site 203513

Prague, Czechia

Location

Chiesi Clinical Trial - Site 203515

Prague, Czechia

Location

Chiesi Clinical Trial - Site 372553

Narva, Estonia

Location

Chiesi Clinical Trial - Site 372551

Tallinn, Estonia

Location

Chiesi Clinical Trial - Site 372552

Tartu, Estonia

Location

Chiesi Clinical Trial - Site 276505

Berlin, Germany

Location

Chiesi Clinical Trial - Site 276506

Berlin, Germany

Location

Chiesi Clinical Trial - Site 276510

Berlin, Germany

Location

Chiesi Clinical Trial - Site 276511

Berlin, Germany

Location

Chiesi Clinical Trial - Site 276515

Berlin, Germany

Location

Chiesi Clinical Trial - Site 276556

Cottbus, Germany

Location

Chiesi Clinical Trial - Site 276509

Darmstadt, Germany

Location

Chiesi Clinical Trial - Site 276503

Delitzsch, Germany

Location

Chiesi Clinical Trial - Site 276504

Frankfurt am Main, Germany

Location

Chiesi Clinical Trial - Site 276557

Geesthacht, Germany

Location

Chiesi Clinical Trial - Site 276501

Hamburg, Germany

Location

Chiesi Clinical Trial - Site 276513

Hamburg, Germany

Location

Chiesi Clinical Trial - Site 276514

Hamburg, Germany

Location

Chiesi Clinical Trial - Site 276558

Hanover, Germany

Location

Chiesi Clinical Trial - Site 276517

Koblenz, Germany

Location

Chiesi Clinical Trial - Site 276502

Leipzig, Germany

Location

Chiesi Clinical Trial - Site 276516

Leipzig, Germany

Location

Chiesi Clinical Trial - Site 276551

Leipzig, Germany

Location

Chiesi Clinical Trial - Site 276507

Mainz, Germany

Location

Chiesi Clinical Trial - Site 276508

Munich, Germany

Location

Chiesi Clinical Trial - Site 276518

Peine, Germany

Location

Chiesi Clinical Trial - Site 300506

Athens, Greece

Location

Chiesi Clinical Trial - Site 300504

Chortiatis, Greece

Location

Chiesi Clinical Trial - Site 300501

Heraklion, Greece

Location

Chiesi Clinical Trial - Site 300503

Ioannina, Greece

Location

Chiesi Clinical Trial - Site 300505

Thessaloniki, Greece

Location

Chiesi Clinical Trial - Site 300507

Volos, Greece

Location

Chiesi Clinical Trial - Site 348506

Balassagyarmat, Hungary

Location

Chiesi Clinical Trial - Site 348501

Budapest, Hungary

Location

Chiesi Clinical Trial - Site 348505

Csorna, Hungary

Location

Chiesi Clinical Trial - Site 348512

Edelény, Hungary

Location

Chiesi Clinical Trial - Site 348508

Gödöllő, Hungary

Location

Chiesi Clinical Trial - Site 348509

Monor, Hungary

Location

Chiesi Clinical Trial - Site 348507

Nyíregyháza, Hungary

Location

Chiesi Clinical Trial - Site 348513

Pécs, Hungary

Location

Chiesi Clinical Trial - Site 348552

Sellye, Hungary

Location

Chiesi Clinical Trial - Site 348510

Szeged, Hungary

Location

Chiesi Clinical Trial - Site 348503

Szombathely, Hungary

Location

Chiesi Clinical Trial - Site 348515

Törökbálint, Hungary

Location

Chiesi Clinical Trial - Site 376502

Ashkelon, Israel

Location

Chiesi Clinical Trial - Site 376501

Beersheba, Israel

Location

Chiesi Clinical Trial - Site 376511

Hadera, Israel

Location

Chiesi Clinical Trial - Site 376508

Haifa, Israel

Location

Chiesi Clinical Trial - Site 376510

Haifa, Israel

Location

Chiesi Clinical Trial - Site 376503

Jerusalem, Israel

Location

Chiesi Clinical Trial - Site 376506

Jerusalem, Israel

Location

Chiesi Clinical Trial - Site 376507

Kfar Saba, Israel

Location

Chiesi Clinical Trial - Site 376504

Ramat Gan, Israel

Location

Chiesi Clinical Trial - Site 376509

Tel Aviv, Israel

Location

Chiesi Clinical Trial - Site 371557

Balvi, Latvia

Location

Chiesi Clinical Trial - Site 371553

Daugavpils, Latvia

Location

Chiesi Clinical Trial - Site 371554

Daugavpils, Latvia

Location

Chiesi Clinical Trial - Site 371555

Jūrmala, Latvia

Location

Chiesi Clinical Trial - Site 371558

Rēzekne, Latvia

Location

Chiesi Clinical Trial - Site 371551

Riga, Latvia

Location

Chiesi Clinical Trial - Site 371552

Riga, Latvia

Location

Chiesi Clinical Trial - Site 371556

Riga, Latvia

Location

Chiesi Clinical Trial - Site 484502

Chihuahua City, Mexico

Location

Chiesi Clinical Trial - Site 484510

Chihuahua City, Mexico

Location

Chiesi Clinical Trial - Site 484505

Córdoba, Mexico

Location

Chiesi Clinical Trial - Site 484506

Cuauhtémoc, Mexico

Location

Chiesi Clinical Trial - Site 484501

Guadalajara, Mexico

Location

Chiesi Clinical Trial - Site 484507

Guadalajara, Mexico

Location

Chiesi Clinical Trial - Site 484509

Guadalajara, Mexico

Location

Chiesi Clinical Trial - Site 484503

Monterrey, Mexico

Location

Chiesi Clinical Trial - Site 484511

Monterrey, Mexico

Location

Chiesi Clinical Trial - Site 484504

Veracruz, Mexico

Location

Chiesi Clinical Trial - Site 528501

Beek, Netherlands

Location

Chiesi Clinical Trial - Site 528504

Breda, Netherlands

Location

Chiesi Clinical Trial - Site 528502

Heerlen, Netherlands

Location

Chiesi Clinical Trial - Site 528505

Leeuwarden, Netherlands

Location

Chiesi Clinical Trial - Site 554504

Christchurch, New Zealand

Location

Chiesi Clinical Trial - Site 554502

Hamilton, New Zealand

Location

Chiesi Clinical Trial - Site 554503

Tauranga, New Zealand

Location

Chiesi Clinical Trial - Site 807555

Bitola, North Macedonia

Location

Chiesi Clinical Trial - Site 807559

Gevgelija, North Macedonia

Location

Chiesi Clinical Trial - Site 807557

Ohrid, North Macedonia

Location

Chiesi Clinical Trial - Site 807553

Shtip, North Macedonia

Location

Chiesi Clinical Trial - Site 807552

Skopje, North Macedonia

Location

Chiesi Clinical Trial - Site 807554

Skopje, North Macedonia

Location

Chiesi Clinical Trial - Site 807556

Skopje, North Macedonia

Location

Chiesi Clinical Trial - Site 616518

Bialystok, Poland

Location

Chiesi Clinical Trial - Site 616504

Giżycko, Poland

Location

Chiesi Clinical Trial - Site 616515

Katowice, Poland

Location

Chiesi Clinical Trial - Site 616522

Katowice, Poland

Location

Chiesi Clinical Trial - Site 616509

Krakow, Poland

Location

Chiesi Clinical Trial - Site 616511

Krakow, Poland

Location

Chiesi Clinical Trial - Site 616514

Krakow, Poland

Location

Chiesi Clinical Trial - Site 616503

Lodz, Poland

Location

Chiesi Clinical Trial - Site 616523

Lodz, Poland

Location

Chiesi Clinical Trial - Site 616519

Ostrowiec Świętokrzyski, Poland

Location

Chiesi Clinical Trial - Site 616506

Poznan, Poland

Location

Chiesi Clinical Trial - Site 616508

Poznan, Poland

Location

Chiesi Clinical Trial - Site 616501

Sosnowiec, Poland

Location

Chiesi Clinical Trial - Site 616502

Torun, Poland

Location

Chiesi Clinical Trial - Site 616554

Wroclaw, Poland

Location

Chiesi Clinical Trial - Site 642510

Bacau, Romania

Location

Chiesi Clinical Trial - Site 642551

Brasov, Romania

Location

Chiesi Clinical Trial - Site 642502

Cluj-Napoca, Romania

Location

Chiesi Clinical Trial - Site 642504

Cluj-Napoca, Romania

Location

Chiesi Clinical Trial - Site 642512

Cluj-Napoca, Romania

Location

Chiesi Clinical Trial - Site 642554

Cluj-Napoca, Romania

Location

Chiesi Clinical Trial - Site 642506

Cluj-Napoca Cluj, Romania

Location

Chiesi Clinical Trial - Site 642508

Cluj-Napoca Cluj, Romania

Location

Chiesi Clinical Trial - Site 642501

Constanța, Romania

Location

Chiesi Clinical Trial - Site 642509

Craiova, Romania

Location

Chiesi Clinical Trial - Site 642511

Craiova, Romania

Location

Chiesi Clinical Trial - Site 642514

Iași, Romania

Location

Chiesi Clinical Trial - Site 642503

Oradea, Romania

Location

Chiesi Clinical Trial - Site 642513

Reșca, Romania

Location

Chiesi Clinical Trial - Site 642505

Timișoara, Romania

Location

Chiesi Clinical Trial - Site 642507

Timișoara, Romania

Location

Chiesi Clinical Trial - Site 642515

Timișoara, Romania

Location

Chiesi Clinical Trial - Site 643517

Kazan', Russia

Location

Chiesi Clinical Trial - Site 643513

Moscow, Russia

Location

Chiesi Clinical Trial - Site 643528

Moscow, Russia

Location

Chiesi Clinical Trial - Site 643516

Nizhny Novgorod, Russia

Location

Chiesi Clinical Trial - Site 643503

Odintsovskiy, Russia

Location

Chiesi Clinical Trial - Site 643504

Saint Petersburg, Russia

Location

Chiesi Clinical Trial - Site 643505

Saint Petersburg, Russia

Location

Chiesi Clinical Trial - Site 643506

Saint Petersburg, Russia

Location

Chiesi Clinical Trial - Site 643508

Saint Petersburg, Russia

Location

Chiesi Clinical Trial - Site 643510

Saint Petersburg, Russia

Location

Chiesi Clinical Trial - Site 643511

Saint Petersburg, Russia

Location

Chiesi Clinical Trial - Site 643512

Saint Petersburg, Russia

Location

Chiesi Clinical Trial - Site 643514

Saint Petersburg, Russia

Location

Chiesi Clinical Trial - Site 643519

Saint Petersburg, Russia

Location

Chiesi Clinical Trial - Site 643520

Saint Petersburg, Russia

Location

Chiesi Clinical Trial - Site 643531

Saint Petersburg, Russia

Location

Chiesi Clinical Trial - Site 643515

Saratov, Russia

Location

Chiesi Clinical Trial - Site 643525

Saratov, Russia

Location

Chiesi Clinical Trial - Site 643521

Ulyanovsk, Russia

Location

Chiesi Clinical Trial - Site 643502

Voronezh, Russia

Location

Chiesi Clinical Trial - Site 643524

Vsevolozhsk, Russia

Location

Chiesi Clinical Trial - Site 643507

Yaroslavl, Russia

Location

Chiesi Clinical Trial - Site 643518

Yaroslavl, Russia

Location

Chiesi Clinical Trial - Site 688552

Belgrade, Serbia

Location

Chiesi Clinical Trial - Site 688553

Belgrade, Serbia

Location

Chiesi Clinical Trial - Site 688555

Belgrade, Serbia

Location

Chiesi Clinical Trial - Site 688557

Belgrade, Serbia

Location

Chiesi Clinical Trial - Site 688558

Belgrade, Serbia

Location

Chiesi Clinical Trial - Site 688559

Belgrade, Serbia

Location

Chiesi Clinical Trial - Site 688561

Belgrade, Serbia

Location

Chiesi Clinical Trial - Site 688569

Belgrade, Serbia

Location

Chiesi Clinical Trial - Site 688570

Jagodina, Serbia

Location

Chiesi Clinical Trial - Site 688564

Kamenitz, Serbia

Location

Chiesi Clinical Trial - Site 688566

Kamenitz, Serbia

Location

Chiesi Clinical Trial - Site 688556

Kragujevac, Serbia

Location

Chiesi Clinical Trial - Site 688562

Leskovac, Serbia

Location

Chiesi Clinical Trial - Site 688554

Niš, Serbia

Location

Chiesi Clinical Trial - Site 688568

Niš, Serbia

Location

Chiesi Clinical Trial - Site 688567

Pančevo, Serbia

Location

Chiesi Clinical Trial - Site 688560

Paraćin, Serbia

Location

Chiesi Clinical Trial - Site 688551

Sombor, Serbia

Location

Chiesi Clinical Trial - Site 688571

Sremska Mitrovica, Serbia

Location

Chiesi Clinical Trial - Site 688563

Užice, Serbia

Location

Chiesi Clinical Trial - Site 688565

Valjevo, Serbia

Location

Chiesi Clinical Trial - Site 703501

Bardejov, Slovakia

Location

Chiesi Clinical Trial - Site 703503

Košice, Slovakia

Location

Chiesi Clinical Trial - Site 703502

Spišská Nová Ves, Slovakia

Location

Chiesi Clinical Trial - Site 408556

Anyang-si, South Korea

Location

Chiesi Clinical Trial - Site 408551

Daegu, South Korea

Location

Chiesi Clinical Trial - Site 408560

Dongjak, South Korea

Location

Chiesi Clinical Trial - Site 408554

Gwangju, South Korea

Location

Chiesi Clinical Trial - Site 408559

Haeundae, South Korea

Location

Chiesi Clinical Trial - Site 408557

Incheon, South Korea

Location

Chiesi Clinical Trial - Site 408558

Incheon, South Korea

Location

Chiesi Clinical Trial - Site 408555

Jeonju, South Korea

Location

Chiesi Clinical Trial - Site 408552

Seoul, South Korea

Location

Chiesi Clinical Trial - Site 408553

Seoul, South Korea

Location

Chiesi Clinical Trial - Site 408561

Suwon,Gyeonggi-do, South Korea

Location

Chiesi Clinical Trial - Site 724503

Barcelona, Spain

Location

Chiesi Clinical Trial - Site 724501

Córdoba, Spain

Location

Chiesi Clinical Trial - Site 724505

Madrid, Spain

Location

Chiesi Clinical Trial - Site 724551

Madrid, Spain

Location

Chiesi Clinical Trial - Site 724504

Majadahonda, Spain

Location

Chiesi Clinical Trial - Site 724502

Zaragoza, Spain

Location

Chiesi Clinical Trial - Site 792512

Adana, Turkey (Türkiye)

Location

Chiesi Clinical Trial - Site 792510

Bornova, Turkey (Türkiye)

Location

Chiesi Clinical Trial - Site 792551

Çanakkale, Turkey (Türkiye)

Location

Chiesi Clinical Trial - Site 792507

Istanbul, Turkey (Türkiye)

Location

Chiesi Clinical Trial - Site 792514

Kocaeli, Turkey (Türkiye)

Location

Chiesi Clinical Trial - Site 792513

Mersin, Turkey (Türkiye)

Location

Chiesi Clinical Trial - Site 792506

Pamukkale, Turkey (Türkiye)

Location

Chiesi Clinical Trial - Site 792508

Pendik, Turkey (Türkiye)

Location

Chiesi Clinical Trial - Site 792511

Yenişehir, Turkey (Türkiye)

Location

Chiesi Clinical Trial - Site 804522

Dnipro, Ukraine

Location

Chiesi Clinical Trial - Site 804502

Ivano-Frankivsk, Ukraine

Location

Chiesi Clinical Trial - Site 804504

Kharkiv, Ukraine

Location

Chiesi Clinical Trial - Site 804505

Kharkiv, Ukraine

Location

Chiesi Clinical Trial - Site 804506

Kharkiv, Ukraine

Location

Chiesi Clinical Trial - Site 804509

Kharkiv, Ukraine

Location

Chiesi Clinical Trial - Site 804503

Kherson, Ukraine

Location

Chiesi Clinical Trial - Site 804511

Kiev, Ukraine

Location

Chiesi Clinical Trial - Site 804520

Kremenchuk, Ukraine

Location

Chiesi Clinical Trial - Site 804501

Kyiv, Ukraine

Location

Chiesi Clinical Trial - Site 804508

Kyiv, Ukraine

Location

Chiesi Clinical Trial - Site 804512

Kyiv, Ukraine

Location

Chiesi Clinical Trial - Site 804516

Kyiv, Ukraine

Location

Chiesi Clinical Trial - Site 804518

Kyiv, Ukraine

Location

Chiesi Clinical Trial - Site 804521

Kyiv, Ukraine

Location

Chiesi Clinical Trial - Site 804527

Odesa, Ukraine

Location

Chiesi Clinical Trial - Site 804507

Poltava, Ukraine

Location

Chiesi Clinical Trial - Site 804515

Vinnytsia, Ukraine

Location

Chiesi Clinical Trial - Site 804517

Vinnytsia, Ukraine

Location

Chiesi Clinical Trial - Site 804528

Zaporizhia, Ukraine

Location

Chiesi Clinical Trial - Site 826510

Belfast, United Kingdom

Location

Chiesi Clinical Trial - Site 826509

Bradford, United Kingdom

Location

Chiesi Clinical Trial - Site 826511

London, United Kingdom

Location

Chiesi Clinical Trial - Site 826512

Rochdale, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic

Interventions

tanimilast; Roflumilast

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Study Officials

• Fernando J. MARTINEZ, Prof.

  Weill Cornell Medical College, New York Presbyterian Hospital, 1305 York avenue box 96 NY 10021 USA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: November 19, 2020
• Study Start: July 12, 2021
• Primary Completion: December 23, 2025
• Study Completion: December 23, 2025
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

HU (12); BU (25); TU (9); UA (20); GB (4); IL (10); ES (3); LA (8); GR (6); AR (24); CL (7); DE (21); ME (10); US (150); RO (17); NZ (3); AU (5); CZ (10); NL (4); NO (7); PL (15); CR (13); BO (13); RU (23); SE (21); KR (11); SL (3)