Search / 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)
Launched by CHIESI FARMACEUTICI S.P.A. · Nov 16, 2020

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Trial Information

Current as of July 26, 2025

Recruiting

Keywords

Copd Chronic Bronchitis Pde4 Inhibitor Anti Inflammatory Respiratory Drug Tanimilast

ClinConnect Summary

This clinical trial, known as the PILLAR study, is looking at the effectiveness and safety of a new medication called CHF6001 (also known as Tanimilast) when added to existing treatments for people with Chronic Obstructive Pulmonary Disease (COPD) and chronic bronchitis. The study will last for 52 weeks and will compare CHF6001 to a placebo (a treatment that looks like the real medication but has no active ingredients) and to another medication called Roflumilast.

To participate in this study, you must be an adult aged 40 or older with COPD and chronic bronchitis, and you should have had at least one moderate or severe worsening of your COPD in the last year. You should also have been on a specific combination of maintenance therapy for at least the past year. The study is currently recruiting participants, and it’s open to both men and women. If you join the trial, you will receive regular check-ups and monitoring to ensure your safety and to see how well the treatment works for improving your condition. It's important to know that certain health issues, like asthma or serious heart problems, may prevent you from participating in this study.

Gender

ALL

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.

About Chiesi Farmaceutici S.P.A.

Chiesi Farmaceutici S.p.A. is a global pharmaceutical company headquartered in Parma, Italy, specializing in the research, development, and commercialization of innovative therapeutic solutions. With a strong focus on respiratory diseases, neonatology, and rare diseases, Chiesi is dedicated to improving patient outcomes through advanced science and technology. The company operates in more than 30 countries and invests significantly in R&D to enhance its product portfolio and expand its global reach. Committed to sustainability and social responsibility, Chiesi adheres to the highest ethical standards in clinical trials and strives to address unmet medical needs with cutting-edge therapies.

Locations

Stara Zagora, , Bulgaria

Andalusia, Alabama, United States

Foley, Alabama, United States

Guntersville, Alabama, United States

Saraland, Alabama, United States

Phoenix, Arizona, United States

Conway, Arkansas, United States

Laguna Hills, California, United States

Los Angeles, California, United States

Newport Beach, California, United States

Northridge, California, United States

Westminster, California, United States

Centennial, Colorado, United States

Lakewood, Colorado, United States

Chiefland, Florida, United States

Clearwater, Florida, United States

Coral Gables, Florida, United States

Cutler Bay, Florida, United States

Daytona Beach, Florida, United States

Debary, Florida, United States

Doral, Florida, United States

Hialeah Gardens, Florida, United States

Hialeah, Florida, United States

Hollywood, Florida, United States

Loxahatchee Groves, Florida, United States

Miami Gardens, Florida, United States

Miami Lakes, Florida, United States

Miami, Florida, United States

Orlando, Florida, United States

Pembroke Pines, Florida, United States

Pompano Beach, Florida, United States

South Miami, Florida, United States

Tampa, Florida, United States

Winter Park, Florida, United States

Adairsville, Georgia, United States

Valdosta, Georgia, United States

Zachary, Louisiana, United States

Annapolis, Maryland, United States

Baltimore, Maryland, United States

Flint, Michigan, United States

Troy, Michigan, United States

Saint Charles, Missouri, United States

Saint Louis, Missouri, United States

Omaha, Nebraska, United States

Las Vegas, Nevada, United States

Bronx, New York, United States

Buffalo, New York, United States

New Windsor, New York, United States

New York, New York, United States

Charlotte, North Carolina, United States

Denver, North Carolina, United States

Gastonia, North Carolina, United States

Huntersville, North Carolina, United States

New Bern, North Carolina, United States

Winston Salem, North Carolina, United States

Cincinnati, Ohio, United States

Dayton, Ohio, United States

Toledo, Ohio, United States

Oklahoma City, Oklahoma, United States

Philadelphia, Pennsylvania, United States

Anderson, South Carolina, United States

Charleston, South Carolina, United States

Fort Mill, South Carolina, United States

North Charleston, South Carolina, United States

Franklin, Tennessee, United States

Knoxville, Tennessee, United States

Baytown, Texas, United States

Boerne, Texas, United States

Cypress, Texas, United States

Kerrville, Texas, United States

Mckinney, Texas, United States

Mesquite, Texas, United States

Pearland, Texas, United States

Plano, Texas, United States

San Antonio, Texas, United States

Sherman, Texas, United States

Sugar Land, Texas, United States

Tomball, Texas, United States

Bellingham, Washington, United States

Morgantown, West Virginia, United States

Greenfield, Wisconsin, United States

Buenos Aires, , Argentina

Ciudad Autonoma Buenos Aires, , Argentina

Ciudad Autónoma De Buenos Aires, , Argentina

Ciudad Autónoma De Buenos Aire, , Argentina

Córdoba, , Argentina

Florencio Varela, , Argentina

Florida, , Argentina

Mar Del Plata, , Argentina

Mendoza, , Argentina

Quilmes, , Argentina

Rosario, , Argentina

San Miguel De Tucumán, , Argentina

San Rafael, , Argentina

Santa Fe, , Argentina

Feldbach, , Austria

Grieskirchen, , Austria

Linz, , Austria

Banja Luka, , Bosnia And Herzegovina

Bihać, , Bosnia And Herzegovina

Bijeljina, , Bosnia And Herzegovina

Foča, , Bosnia And Herzegovina

Gradiška, , Bosnia And Herzegovina

Mostar, , Bosnia And Herzegovina

Sarajevo, , Bosnia And Herzegovina

Travnik, , Bosnia And Herzegovina

Trebinje, , Bosnia And Herzegovina

Tuzla, , Bosnia And Herzegovina

Zenica, , Bosnia And Herzegovina

Blagoevgrad, , Bulgaria

Dimitrovgrad, , Bulgaria

Gabrovo, , Bulgaria

Haskovo, , Bulgaria

Kozloduy, , Bulgaria

Lovech, , Bulgaria

Montana, , Bulgaria

Pernik, , Bulgaria

Pleven, , Bulgaria

Plovdiv, , Bulgaria

Razgrad, , Bulgaria

Ruse, , Bulgaria

Sevlievo, , Bulgaria

Sofia, , Bulgaria

Vidin, , Bulgaria

Concepcion, , Chile

Quillota, , Chile

Santiago, , Chile

Talca, , Chile

Valparaiso, , Chile

Dubrovnik, , Croatia

Karlovac, , Croatia

Osijek, , Croatia

Rijeka, , Croatia

Sisak, , Croatia

Split, , Croatia

Zadar, , Croatia

Zagreb, , Croatia

Brandýs Nad Labem, , Czechia

Havlíčkův Brod, , Czechia

Jindřichův Hradec, , Czechia

Miroslav, , Czechia

Mladá Boleslav, , Czechia

Měšice, , Czechia

Praha, , Czechia

Narva, , Estonia

Tallinn, , Estonia

Tartu, , Estonia

Berlin, , Germany

Cottbus, , Germany

Darmstadt, , Germany

Delitzsch, , Germany

Frankfurt Am Main, , Germany

Geesthacht, , Germany

Hamburg, , Germany

Hannover, , Germany

Koblenz, , Germany

Leipzig, , Germany

Mainz, , Germany

Munich, , Germany

Peine, , Germany

Athens, , Greece

Chortiátis, , Greece

Heraklion, , Greece

Ioannina, , Greece

Thessaloníki, , Greece

Volos, , Greece

Balassagyarmat, , Hungary

Budapest, , Hungary

Csorna, , Hungary

Edelény, , Hungary

Gödöllő, , Hungary

Monor, , Hungary

Nyíregyháza, , Hungary

Pécs, , Hungary

Sellye, , Hungary

Szeged, , Hungary

Szombathely, , Hungary

Törökbálint, , Hungary

Ashkelon, , Israel

Be'er Sheva, , Israel

Hadera, , Israel

Haifa, , Israel

Jerusalem, , Israel

Kfar Saba, , Israel

Ramat Gan, , Israel

Tel Aviv, , Israel

Anyang Si, , Korea, Republic Of

Daegu, , Korea, Republic Of

Dongjak, , Korea, Republic Of

Gwangju, , Korea, Republic Of

Haeundae, , Korea, Republic Of

Incheon, , Korea, Republic Of

Jeonju, , Korea, Republic Of

Seoul, , Korea, Republic Of

Suwon,Gyeonggi Do, , Korea, Republic Of

Balvi, , Latvia

Daugavpils, , Latvia

Jūrmala, , Latvia

Riga, , Latvia

Rēzekne, , Latvia

Rīga, , Latvia

Chihuahua, , Mexico

Cordoba, , Mexico

Cuauhtémoc, , Mexico

Guadalajara, , Mexico

Monterrey, , Mexico

Veracruz, , Mexico

Beek, , Netherlands

Breda, , Netherlands

Heerlen, , Netherlands

Leeuwarden, , Netherlands

Christchurch, , New Zealand

Hamilton, , New Zealand

Tauranga, , New Zealand

Bitola, , North Macedonia

Gevgelija, , North Macedonia

Ohrid, , North Macedonia

Shtip, , North Macedonia

Skopje, , North Macedonia

Bialystok, , Poland

Giżycko, , Poland

Katowice, , Poland

Krakow, , Poland

Kraków, , Poland

Ostrowiec świętokrzyski, , Poland

Poznań, , Poland

Sosnowiec, , Poland

Torun, , Poland

Wrocław, , Poland

łódź, , Poland

Bacău, , Romania

Braşov, , Romania

Cluj Napoca Cluj, , Romania

Cluj Napoca, , Romania

Cluj, , Romania

Constanţa, , Romania

Craiova, , Romania

Iaşi, , Romania

Oradea, , Romania

Resca, , Romania

Timisoara, , Romania

Timişoara, , Romania

Kazan, , Russian Federation

Moscow, , Russian Federation

Nizhniy Novgorod, , Russian Federation

Odintsovskiy, , Russian Federation

Saint Petersburg, , Russian Federation

Sankt Peterburg, , Russian Federation

Saratov, , Russian Federation

Ulyanovsk, , Russian Federation

Voronezh, , Russian Federation

Vsevolozhsk, , Russian Federation

Yaroslavl, , Russian Federation

Belgrade, , Serbia

Jagodina, , Serbia

Kragujevac, , Serbia

Leskovac, , Serbia

Niš, , Serbia

Pančevo, , Serbia

Paraćin, , Serbia

Sombor, , Serbia

Sremska Kamenica, , Serbia

Sremska Mitrovica, , Serbia

Užice, , Serbia

Valjevo, , Serbia

Bardejov, , Slovakia

Košice, , Slovakia

Spišská Nová Ves, , Slovakia

Barcelona, , Spain

Cordoba, , Spain

Madrid, , Spain

Majadahonda, , Spain

Zaragoza, , Spain

Adana, , Turkey

Bornova, , Turkey

Istanbul, , Turkey

Kocaeli, , Turkey

Mersin, , Turkey

Pamukkale, , Turkey

Pendik, , Turkey

Yenişehir, , Turkey

çanakkale, , Turkey

Dnipro, , Ukraine

Ivano Frankivs'k, , Ukraine

Kharkiv, , Ukraine

Kharkov, , Ukraine

Kherson, , Ukraine

Kiev, , Ukraine

Kremenchuk, , Ukraine

Kyiv, , Ukraine

Odessa, , Ukraine

Vinnytsia, , Ukraine

Zaporizhia, , Ukraine

Belfast, , United Kingdom

Bradford, , United Kingdom

London, , United Kingdom

Rochdale, , United Kingdom

Northridge, California, United States

Pomona, California, United States

Hialeah, Florida, United States

Homestead, Florida, United States

Miami, Florida, United States

Pembroke Pines, Florida, United States

Saint Petersburg, Florida, United States

East Point, Georgia, United States

Port Gibson, Mississippi, United States

Henderson, Nevada, United States

North Las Vegas, Nevada, United States

Tulsa, Oklahoma, United States

Carrollton, Texas, United States

Portsmouth, Virginia, United States

Buenos Aires, , Argentina

Wels, , Austria

Poltava, , Ukraine

Muncie, Indiana, United States

North Dartmouth, Massachusetts, United States

Bayonne, New Jersey, United States

Charlotte, North Carolina, United States

Houston, Texas, United States

Milwaukee, Wisconsin, United States

Mobile, Alabama, United States

Hollywood, Florida, United States

Saint Petersburg, Florida, United States

Columbus, Georgia, United States

Cordele, Georgia, United States

Stonecrest, Georgia, United States

Saint Louis, Missouri, United States

New York, New York, United States

Shelby, North Carolina, United States

Columbus, Ohio, United States

Rock Hill, South Carolina, United States

Houston, Texas, United States

San Antonio, Texas, United States

Everett, Washington, United States

Concepción Del Uruguay, , Argentina

Brooksville, Florida, United States

Melbourne, Florida, United States

College Park, Georgia, United States

Dallas, Texas, United States

North Richland Hills, Texas, United States

Patients applied

0 patients applied

Trial Officials

Fernando J. MARTINEZ, Prof.

Principal Investigator

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

Timeline

First submit

November 16, 2020

Trial launched

July 12, 2021

Trial updated

March 11, 2025

Estimated completion

Not reported

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