AzTrials
AzTrials

Chronic Obstructive Pulmonary DiseasePhase 3PILASTERNCT04636801

A 52-week, Placebo-controlled Study to Evaluate the Efficacy and Safety of 2 Doses of CHF6001 DPI (Tanimilast), as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis (PILASTER)

A Phase 3 study testing Experimental: CHF6001 1600µg and Experimental: CHF6001 3200µg in people with Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 447 sites in 30 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 the study is to evaluate the efficacy and safety of two doses of CHF6001 (Tanimilast), as add-on to maintenance triple therapy in the target patient population. 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?
Experimental: CHF6001 1600µg and Experimental: CHF6001 3200µg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
4,710 participants
Where
447 sitesin 30 countries
Study dates
14 Jul 2021to 31 Oct 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 chronic bronchitis
  • Current or ex-smokers (history ≥ 10 pack years).
  • Post-bronchodilator FEV1 <60% of the subject predicted normal value and FEV1/FVC ratio < 0.7.
  • At least, one moderate or severe COPD exacerbation in previous year.
  • CAT score ≥ 10
  • Subjects on regular maintenance triple therapy for at least 12 months prior to screening and receiving regular maintenance triple therapy for at least 3 months prior to screening visit

Who cannot join

  • Subjects with current asthma.
  • Subjects with moderate or severe COPD exacerbation 4 weeks prior to study entry and randomization.
  • Subjects with known α-1 antitrypsin deficiency as the underlying cause of COPD.
  • Subjects with COPD emphysema or mixed phenotypes.
  • Subjects with known respiratory disorders other than COPD.
  • Subjects with active cancer or a history of lung cancer with full recovery less than 1 year after completing cancer therapy.
Show all 12Show fewer
  • Subjects under Roflumilast treatment within 6 months before study entry.
  • Subjects with a diagnosis of depression, generalised anxiety disorder, suicidal ideation.
  • Subjects with clinically significant cardiovascular.
  • Subjects with a significant neurological disease.
  • Subjects with clinically significant laboratory abnormalities.
  • Subjects with moderate or severe hepatic impairment

Trial locations and contacts

447 sites in 30 countries.

447 sites in 30 countries

China60 sites

  • Chiesi Clinical Trial - Site 156473

    Baotou

  • Chiesi Clinical Trial - Site 156507

    Baotou

  • Chiesi Clinical Trial - Site 156474

    Beijing

  • Chiesi Clinical Trial - Site 156489

    Beijing

  • Chiesi Clinical Trial - Site 156509

    Beijing

  • Chiesi Clinical Trial - Site 156501

    Changchun

  • Chiesi Clinical Trial - Site 156455

    Changsha

  • Chiesi Clinical Trial - Site 156488

    Changsha

  • Chiesi Clinical Trial - Site 156451

    Chengdu

  • Chiesi Clinical Trial - Site 156490

    Chengdu

  • Chiesi Clinical Trial - Site 156463

    Chongqing

  • Chiesi Clinical Trial - Site 156511

    Chongqing

  • Chiesi Clinical Trial - Site 156452

    Guangzhou

  • Chiesi Clinical Trial - Site 156460

    Guangzhou

  • Chiesi Clinical Trial - Site 156471

    Guangzhou

  • Chiesi Clinical Trial - Site 156472

    Guangzhou

  • Chiesi Clinical Trial - Site 156494

    Guangzhou

  • Chiesi Clinical Trial - Site 156504

    Guangzhou

  • Chiesi Clinical Trial - Site 156468

    Haikou

  • Chiesi Clinical Trial - Site 156498

    Hangzhou

  • Chiesi Clinical Trial - Site 156510

    Harbin

  • Chiesi Clinical Trial - Site 156486

    Hefei

  • Chiesi Clinical Trial - Site 156503

    Hefei

  • Chiesi Clinical Trial - Site 156483

    Hengyang

  • Chiesi Clinical Trial - Site 156512

    Hohhot

  • Chiesi Clinical Trial - Site 156495

    Huanghou

  • Chiesi Clinical Trial - Site 156506

    Huizhou

  • Chiesi Clinical Trial - Site 156456

    Jinan

  • Chiesi Clinical Trial - Site 156485

    Jinhua

  • Chiesi Clinical Trial - Site 156454

    Liaoyang

  • Chiesi Clinical Trial - Site 156453

    Nanchang

  • Chiesi Clinical Trial - Site 156467

    Nanchang

  • Chiesi Clinical Trial - Site 156484

    Nanjing

  • Chiesi Clinical Trial - Site 156496

    Nanjing

  • Chiesi Clinical Trial - Site 156497

    Nanjing

  • Chiesi Clinical Trial - Site 156481

    Pingxiang

  • Chiesi Clinical Trial - Site 156464

    Qingyuan

  • Chiesi Clinical Trial - Site 156458

    Shanghai

  • Chiesi Clinical Trial - Site 156461

    Shanghai

  • Chiesi Clinical Trial - Site 156475

    Shanghai

  • Chiesi Clinical Trial - Site 156476

    Shanghai

  • Chiesi Clinical Trial - Site 156477

    Shanghai

  • Chiesi Clinical Trial - Site 156487

    Shanghai

  • Chiesi Clinical Trial - Site 156457

    Suzhou

  • Chiesi Clinical Trial - Site 156499

    Taiyuan

  • Chiesi Clinical Trial - Site 156469

    Taizhou

  • Chiesi Clinical Trial - Site 156465

    Tianjin

  • Chiesi Clinical Trial - Site 156480

    Tianjin

  • Chiesi Clinical Trial - Site 156491

    Wuhan

  • Chiesi Clinical Trial - Site 156505

    Wuhan

  • Chiesi Clinical Trial - Site 156492

    Wuxi

  • Chiesi Clinical Trial - Site 156493

    Wuxi

  • Chiesi Clinical Trial - Site 156470

    Xiangtan

  • Chiesi Clinical Trial - Site 156482

    Xining

  • Chiesi Clinical Trial - Site 156478

    Xinxiang

  • Chiesi Clinical Trial - Site 156466

    Xuzhou

  • Chiesi Clinical Trial - Site 156479

    Xuzhou

  • Chiesi Clinical Trial - Site 156508

    Yanji

  • Chiesi Clinical Trial - Site 156459

    Yiyang

  • Chiesi Clinical Trial - Site 156462

    Zhanjiang

Other trials in China

Ukraine38 sites

  • LLC "Euromedservice" - Site 804463

    Chernivtsi, 58029

  • Chiesi Clinical Trial - Site 804452

    Chernivtsi

  • Chiesi Clinical Trial - Site 804422

    Dnipro

  • Chiesi Clinical Trial - Site 804458

    Dnipro

  • Ivano-Frankivsk City Clinical Hospital No. 1 - Site 804453

    Ivano-Frankivsk, 76018

  • The Ivano-Frankivsk National Medical Univeristy - Site 804465

    Ivano-Frankivsk, 76018

  • Chiesi Clinical Trial - Site 804402

    Ivano-Frankivsk

  • Chiesi Clinical Trial - Site 804453

    Ivano-Frankivsk

  • Chiesi Clinical Trial - Site 804404

    Kharkiv

  • Chiesi Clinical Trial - Site 804405

    Kharkiv

  • Chiesi Clinical Trial - Site 804406

    Kharkiv

  • Chiesi Clinical Trial - Site 804409

    Kharkiv

  • Chiesi Clinical Trial - Site 804450

    Kharkiv

  • Chiesi Clinical Trial - Site 804457

    Kharkiv

  • Chiesi Clinical Trial - Site 804403

    Kherson

  • Chiesi Clinical Trial - Site 804421

    Kiev

  • Chiesi Clinical Trial - Site 804459

    Kiev

  • Municipal Non-profit Enterpirse-Regional Territorial Medical - Site 804454

    Kramatorsk, 84307

  • Chiesi Clinical Trial - Site 804420

    Kremenchuk

  • Chiesi Clinical Trial - Site 804451

    Kryvyi Rih

  • ARENSIA Exploratory Medicine Medical Center - Site 804468

    Kyiv, 01135

  • Medical Center- OkClinic of International Institute of Clinical Studies, LLC - Site 804466

    Kyiv, 02091

  • Chiesi Clinical Trial - Site 804401

    Kyiv

  • Chiesi Clinical Trial - Site 804408

    Kyiv

  • Chiesi Clinical Trial - Site 804411

    Kyiv

  • Chiesi Clinical Trial - Site 804412

    Kyiv

  • Chiesi Clinical Trial - Site 804416

    Kyiv

  • Chiesi Clinical Trial - Site 804460

    Kyiv

  • Chiesi Clinical Trial - Site 804462

    Kyiv

  • Chiesi Clinical Trial - Site 804427

    Odesa

  • Limited Liability Company Medical and Diagnostic Center "Medion" - Site 804407

    Poltava, 36039

  • Chiesi Clinical Trial - Site 804415

    Vinnytsia

  • Chiesi Clinical Trial - Site 804417

    Vinnytsia

  • Chiesi Clinical Trial - Site 804455

    Vinnytsia

  • Chiesi Clinical Trial - Site 804456

    Vinnytsia

  • Chiesi Clinical Trial - Site 804423

    Zaporizhzhya

  • Chiesi Clinical Trial - Site 804426

    Zaporizhzhya

  • Central City Hospital No.1 - Zhytomyr - Site 804467

    Zhytomyr, 10002

Other trials in Ukraine

Russia35 sites

  • Chiesi Clinical Trial - Site 643433

    Chelyabinsk

  • Chiesi Clinical Trial - Site 643417

    Kazan'

  • Chiesi Clinical Trial - Site 643462

    Kazan'

  • Chiesi Clinical Trial - Site 643456

    Kemerovo

  • Chiesi Clinical Trial - Site 643401

    Moscow

  • Chiesi Clinical Trial - Site 643413

    Moscow

  • Chiesi Clinical Trial - Site 643428

    Moscow

  • Chiesi Clinical Trial - Site 643460

    Moscow

  • Chiesi Clinical Trial - Site 643454

    Moskva

  • Chiesi Clinical Trial - Site 643416

    Nizhny Novgorod

  • Chiesi Clinical Trial - Site 643403

    Odintsovskiy

  • Chiesi Clinical Trial - Site 643457

    Rostov-on-Don

  • Chiesi Clinical Trial - Site 643459

    Rostov-on-Don

  • Chiesi Clinical Trial - Site 643404

    Saint Petersburg

  • Chiesi Clinical Trial - Site 643405

    Saint Petersburg

  • Chiesi Clinical Trial - Site 643406

    Saint Petersburg

  • Chiesi Clinical Trial - Site 643408

    Saint Petersburg

  • Chiesi Clinical Trial - Site 643410

    Saint Petersburg

  • Chiesi Clinical Trial - Site 643411

    Saint Petersburg

  • Chiesi Clinical Trial - Site 643412

    Saint Petersburg

  • Chiesi Clinical Trial - Site 643414

    Saint Petersburg

  • Chiesi Clinical Trial - Site 643419

    Saint Petersburg

  • Chiesi Clinical Trial - Site 643420

    Saint Petersburg

  • Chiesi Clinical Trial - Site 643423

    Saint Petersburg

  • Chiesi Clinical Trial - Site 643424

    Saint Petersburg

  • Chiesi Clinical Trial - Site 643431

    Saint Petersburg

  • Chiesi Clinical Trial - Site 643458

    Saint Petersburg

  • Chiesi Clinical Trial - Site 643451

    Saint-Peterburg

  • Chiesi Clinical Trial - Site 643415

    Saratov

  • Chiesi Clinical Trial - Site 643425

    Saratov

  • Chiesi Clinical Trial - Site 643421

    Ulyanovsk

  • Chiesi Clinical Trial - Site 643402

    Voronezh

  • Chiesi Clinical Trial - Site 643407

    Yaroslavl

  • Chiesi Clinical Trial - Site 643418

    Yaroslavl

  • Chiesi Clinical Trial - Site 643426

    Yaroslavl

Other trials in Russia

Bulgaria29 sites

  • Chiesi Clinical Trial - Site 100435

    Blagoevgrad

  • Chiesi Clinical Trial - Site 100434

    Dimitrovgrad

  • Chiesi Clinical Trial - Site 100453

    Gabrovo

  • Chiesi Clinical Trial - Site 100423

    Haskovo

  • Chiesi Clinical Trial - Site 100433

    Kozloduy

  • Chiesi Clinical Trial - Site 100455

    Lovech

  • Chiesi Clinical Trial - Site 100415

    Montana

  • Chiesi Clinical Trial - Site 100432

    Pernik

  • Chiesi Clinical Trial - Site 100422

    Pleven

  • Chiesi Clinical Trial - Site 100452

    Plovdiv

  • Chiesi Clinical Trial - Site 100456

    Plovdiv

  • Chiesi Clinical Trial - Site 100437

    Razgrad

  • Chiesi Clinical Trial - Site 100412

    Rousse

  • Chiesi Clinical Trial - Site 100416

    Rousse

  • Chiesi Clinical Trial - Site 100436

    Sevlievo

  • Chiesi Clinical Trial - Site 100460

    Sliven

  • Chiesi Clinical Trial - Site 100409

    Sofia

  • Chiesi Clinical Trial - Site 100414

    Sofia

  • Chiesi Clinical Trial - Site 100417

    Sofia

  • Chiesi Clinical Trial - Site 100418

    Sofia

  • Chiesi Clinical Trial - Site 100420

    Sofia

  • Chiesi Clinical Trial - Site 100430

    Sofia

  • Chiesi Clinical Trial - Site 100431

    Sofia

  • Chiesi Clinical Trial - Site 100438

    Sofia

  • Chiesi Clinical Trial - Site 100424

    Stara Zagora

  • Chiesi Clinical Trial - Site 100454

    Stara Zagora

  • Chiesi Clinical Trial - Site 100462

    Veliko Tarnovo

  • Chiesi Clinical Trial - Site 100419

    Vidin

  • Chiesi Clinical Trial - Site 100457

    Vidin

Other trials in Bulgaria

Argentina28 sites

  • Chiesi Clinical Trial - Site 32415

    Buenos Aires, 7540

  • Chiesi Clinical Trial - Site 32407

    Buenos Aires

  • Chiesi Clinical Trial - Site 32410

    Buenos Aires

  • Chiesi Clinical Trial - Site 32454

    Buenos Aires

  • Chiesi Clinical Trial - Site 32457

    Caba

  • Chiesi Clinical Trial - Site 32459

    CABA

  • Chiesi Clinical Trial - Site 32414

    Ciudad Autonoma de Buenos Aire

  • Chiesi Clinical Trial - Site 32403

    Córdoba

  • Chiesi Clinical Trial - Site 32409

    Córdoba

  • Chiesi Clinical Trial - Site 32401

    Florida

  • Centro de Medicina Respiratoria - Concepcion del Uruguay - site 32463

    Forestal Entre Ríos, 89862-000

  • Chiesi Clinical Trial - Site 32455

    La Plata

  • Chiesi Clinical Trial - Site 32458

    Mar del Plata

  • Chiesi Clinical Trial - Site 32462

    Mar del Plata

  • Chiesi Clinical Trial - Site 32405

    Mendoza

  • Chiesi Clinical Trial - Site 32411

    Mendoza

  • Chiesi Clinical Trial - Site 32413

    Mendoza

  • Chiesi Clinical Trial - Site 32402

    Monte Grande

  • Chiesi Clinical Trial - Site 32406

    Quilmes

  • Chiesi Clinical Trial - Site 32453

    Rosario

  • Chiesi Clinical Trial - Site 32460

    San Fernando

  • Chiesi Clinical Trial - Site 32408

    San Juan Bautista

  • Chiesi Clinical Trial - Site 32412

    San Miguel de Tucumán

  • Chiesi Clinical Trial - Site 32451

    San Miguel de Tucumán

  • Chiesi Clinical Trial - Site 32452

    San Miguel de Tucumán

  • Chiesi Clinical Trial - Site 32461

    San Miguel de Tucumán

  • Chiesi Clinical Trial - Site 32464

    San Miguel de Tucumán

  • Chiesi Clinical Trial - Site 32456

    Santa Fe

Other trials in Argentina

Germany26 sites

  • Chiesi Clinical Trial - Site 276462

    Bamberg

  • Chiesi Clinical Trial - Site 276405

    Berlin

  • Chiesi Clinical Trial - Site 276406

    Berlin

  • Chiesi Clinical Trial - Site 276410

    Berlin

  • Chiesi Clinical Trial - Site 276411

    Berlin

  • Chiesi Clinical Trial - Site 276415

    Berlin

  • Chiesi Clinical Trial - Site 276452

    Berlin

  • Chiesi Clinical Trial - Site 276453

    Berlin

  • Chiesi Clinical Trial - Site 276457

    Berlin

  • Chiesi Clinical Trial - Site 276456

    Cottbus

  • Chiesi Clinical Trial - Site 276409

    Darmstadt

  • Chiesi Clinical Trial - Site 276403

    Delitzsch

  • Chiesi Clinical Trial - Site 276455

    Essen

  • Chiesi Clinical Trial - Site 276404

    Frankfurt

  • Chiesi Clinical Trial - Site 276401

    Hamburg

  • Chiesi Clinical Trial - Site 276413

    Hamburg

  • Chiesi Clinical Trial - Site 276463

    Hanover

  • Chiesi Clinical Trial - Site 276417

    Koblenz

  • Chiesi Clinical Trial - Site 276402

    Leipzig

  • Chiesi Clinical Trial - Site 276416

    Leipzig

  • Chiesi Clinical Trial - Site 276461

    Leipzig

  • Chiesi Clinical Trial - Site 276407

    Mainz

  • Chiesi Clinical Trial - Site 276408

    Munich

  • Chiesi Clinical Trial - Site 276459

    Münster

  • Chiesi Clinical Trial - Site 276418

    Peine

  • Chiesi Clinical Trial - Site 276464

    Schleswig

Other trials in Germany

Poland24 sites

  • Chiesi Clinical Trial - Site 616413

    Bialystok

  • Chiesi Clinical Trial - Site 616418

    Bialystok

  • HolsaClinical - Gyncentrum Bielsko-Biala - Site 616460

    Bielsko-Biala, 43-300

  • Chiesi Clinical Trial - Site 616404

    Giżycko

  • Chiesi Clinical Trial - Site 616415

    Katowice

  • Chiesi Clinical Trial - Site 616422

    Katowice

  • Chiesi Clinical Trial - Site 616409

    Krakow

  • Chiesi Clinical Trial - Site 616411

    Krakow

  • Chiesi Clinical Trial - Site 616414

    Krakow

  • Chiesi Clinical Trial - Site 616455

    Krakow

  • AmiCare Medical Centre - Site 616459

    Lodz, 91-495

  • Chiesi Clinical Trial - Site 616403

    Lodz

  • Chiesi Clinical Trial - Site 616423

    Lodz

  • Chiesi Clinical Trial - Site 616458

    Lodz

  • Chiesi Clinical Trial - Site 616457

    Lublin

  • Chiesi Clinical Trial - Site 616419

    Ostrowiec

  • Chiesi Clinical Trial - Site 616456

    Piaseczno

  • Chiesi Clinical Trial - Site 616406

    Poznan

  • Chiesi Clinical Trial - Site 616408

    Poznan

  • Chiesi Clinical Trial - Site 616401

    Sosnowiec

  • Chiesi Clinical Trial - Site 616451

    Tarnów

  • Chiesi Clinical Trial - Site 616402

    Torun

  • Chiesi Clinical Trial - Site 616452

    Wroclaw

  • Chiesi Clinical Trial - Site 616454

    Wroclaw

Other trials in Poland

Hungary18 sites

  • Chiesi Clinical Trial - Site 348406

    Balassagyarmat

  • Chiesi Clinical Trial - Site 348401

    Budapest

  • Chiesi Clinical Trial - Site 348457

    Budapest

  • Chiesi Clinical Trial - Site 348459

    Budapest

  • Chiesi Clinical Trial - Site 348405

    Csorna

  • Chiesi Clinical Trial - Site 348412

    Edelény

  • Chiesi Clinical Trial - Site 348408

    Gödöllő

  • Chiesi Clinical Trial - Site 348451

    Gyula

  • Chiesi Clinical Trial - Site 348409

    Monor

  • Chiesi Clinical Trial - Site 348407

    Nyíregyháza

  • Chiesi Clinical Trial - Site 348413

    Pécs

  • Chiesi Clinical Trial - Site 348452

    Sellye

  • Chiesi Clinical Trial - Site 348458

    Százhalombatta

  • Chiesi Clinical Trial - Site 348410

    Szeged

  • Chiesi Clinical Trial - Site 348461

    Szolnok

  • Chiesi Clinical Trial - Site 348403

    Szombathely

  • Chiesi Clinical Trial - Site 348453

    Tatabánya

  • Chiesi Clinical Trial - Site 348415

    Törökbálint

Other trials in Hungary

Romania18 sites

  • Chiesi Clinical Trial - Site 642410

    Bacau

  • Chiesi Clinical Trial - Site 642452

    Bragadiru

  • Chiesi Clinical Trial - Site 642402

    Cluj-Napoca

  • Chiesi Clinical Trial - Site 642404

    Cluj-Napoca

  • Chiesi Clinical Trial - Site 642406

    Cluj-Napoca

  • Chiesi Clinical Trial - Site 642408

    Cluj-Napoca

  • Chiesi Clinical Trial - Site 642412

    Cluj-Napoca

  • Chiesi Clinical Trial - Site 642454

    Cluj-Napoca

  • Chiesi Clinical Trial - Site 642401

    Constanța

  • Chiesi Clinical Trial - Site 642409

    Craiova

  • Chiesi Clinical Trial - Site 642411

    Craiova

  • Chiesi Clinical Trial - Site 642453

    Deva

  • Chiesi Clinical Trial - Site 642414

    Iași

  • Chiesi Clinical Trial - Site 642403

    Oradea

  • Chiesi Clinical Trial - Site 642413

    Reșca

  • Chiesi Clinical Trial - Site 642405

    Timișoara

  • Chiesi Clinical Trial - Site 642407

    Timișoara

  • Chiesi Clinical Trial - Site 642415

    Timișoara

Other trials in Romania

Czechia16 sites

  • Chiesi Clinical Trial - Site 203406

    Brandýs nad Labem

  • Chiesi Clinical Trial - Site 203418

    Havlíčkův Brod

  • Chiesi Clinical Trial - Site 203401

    Jindřichův Hradec

  • Chiesi Clinical Trial - Site 203410

    Lovosice

  • Chiesi Clinical Trial - Site 203417

    Měšice

  • Chiesi Clinical Trial - Site 203404

    Miroslav

  • Chiesi Clinical Trial - Site 203416

    Mladá Boleslav

  • Chiesi Clinical Trial - Site 203453

    Olomouc

  • Chiesi Clinical Trial - Site 203405

    Prague

  • Chiesi Clinical Trial - Site 203407

    Prague

  • Chiesi Clinical Trial - Site 203413

    Prague

  • Chiesi Clinical Trial - Site 203415

    Prague

  • Chiesi Clinical Trial - Site 203452

    Prague

  • Chiesi Clinical Trial - Site 203402

    Strakonice

  • Chiesi Clinical Trial - Site 203451

    Tábor

  • Chiesi Clinical Trial - Site 203412

    Varnsdorf

Other trials in Czechia

United States15 sites

  • Chiesi Clinical Trial - Site 840487

    Cutler Bay, Florida, 33189-1230

  • Chiesi Clinical Trial - Site 840404

    Hollywood, Florida, 33021

  • Chiesi Clinical Trial - Site 840474

    Kerrville, Texas, 78028-9640

  • Chiesi Clinical Trial - Site 840407

    Miami, Florida, 33144-2100

  • Chiesi Clinical Trial - Site 840444

    Miami, Florida, 33144

  • Chiesi Clinical Trial - Site 840437

    Miami, Florida, 33165-2075

  • Chiesi Clinical Trial - Site 840403

    Miami, Florida, 33175-3598

  • Chiesi Clinical Trial - Site 840478

    New Windsor, New York, 12553-7754

  • Chiesi Clinical Trial - Site 840480

    Northridge, California, 91324-6200

  • Chiesi Clinical Trial - Site 840463

    Orlando, Florida, 32822-5806

  • Chiesi Clinical Trial - Site 840401

    Peachtree Corners, Georgia, 30071-2656

  • Chiesi Clinical Trial - Site 840483

    Philadelphia, Pennsylvania, 19140

  • Chiesi Clinical Trial - Site 840409

    Plano, Texas, 75025

  • Chiesi Clinical Trial - Site 840481

    San Antonio, Texas, 78229

  • Chiesi Clinical Trial - Site 840402

    Sheffield, Alabama, 35660-4020

Other trials in United States

Mexico12 sites

  • Chiesi Clinical Trial - Site 484402

    Chihuahua City

  • Chiesi Clinical Trial - Site 484410

    Chihuahua City

  • Chiesi Clinical Trial - Site 484405

    Córdoba

  • Chiesi Clinical Trial - Site 484452

    Durango

  • Chiesi Clinical Trial - Site 484401

    Guadalajara

  • Chiesi Clinical Trial - Site 484407

    Guadalajara

  • Chiesi Clinical Trial - Site 484409

    Guadalajara

  • Chiesi Clinical Trial - Site 484453

    Guadalajara

  • Chiesi Clinical Trial - Site 484406

    Mexico City

  • Chiesi Clinical Trial - Site 484403

    Monterrey

  • Chiesi Clinical Trial - Site 484411

    Monterrey

  • Chiesi Clinical Trial - Site 484404

    Veracruz

Other trials in Mexico

Spain11 sites

  • Chiesi Clinical Trial - Site 724454

    Barakaldo

  • Chiesi Clinical Trial - Site 724403

    Barcelona

  • Chiesi Clinical Trial - Site 724457

    Barcelona

  • Chiesi Clinical Trial - Site 724401

    Córdoba

  • Chiesi Clinical Trial - Site 724404

    Madrid

  • Chiesi Clinical Trial - Site 724405

    Madrid

  • Chiesi Clinical Trial - Site 724451

    Madrid

  • Chiesi Clinical Trial - Site 724455

    Palma de Mallorca

  • Chiesi Clinical Trial - Site 724458

    Pontevedra

  • Chiesi Clinical Trial - Site 724452

    Valencia

  • Chiesi Clinical Trial - Site 724402

    Zaragoza

Other trials in Spain

Albania10 sites

  • Chiesi Clinical Trial - Site 8455

    Durrës

  • Chiesi Clinical Trial - Site 8459

    Durrës

  • Chiesi Clinical Trial - Site 8457

    Elbasan

  • Chiesi Clinical Trial - Site 8460

    Korçë

  • Chiesi Clinical Trial - Site 8451

    Tirana

  • Chiesi Clinical Trial - Site 8452

    Tirana

  • Chiesi Clinical Trial - Site 8453

    Tirana

  • Chiesi Clinical Trial - Site 8454

    Tirana

  • Chiesi Clinical Trial - Site 8456

    Tirana

  • Chiesi Clinical Trial - Site 8458

    Tirana

Other trials in Albania

Bosnia and Herzegovina10 sites

  • Chiesi Clinical Trial - Site 070401

    Banja Luka

  • Chiesi Clinical Trial - Site 070407

    Doboj

  • Chiesi Clinical Trial - Site 070460

    Mostar

  • Chiesi Clinical Trial - Site 070404

    Pale

  • OJ Dom zdravlja Novo Sarajevo "Omer Maslić" - Site 70408

    Sarajevo, 71000

  • Chiesi Clinical Trial - Site 070405

    Sarajevo

  • Chiesi Clinical Trial - Site 070406

    Sarajevo

  • Chiesi Clinical Trial - Site 070403

    Tešanj

  • Chiesi Clinical Trial - Site 070402

    Tuzla

  • Chiesi Clinical Trial - Site 070463

    Tuzla

Other trials in Bosnia and Herzegovina

Israel10 sites

  • Chiesi Clinical Trial - Site 376402

    Ashkelon

  • Chiesi Clinical Trial - Site 376401

    Beersheba

  • Chiesi Clinical Trial - Site 376408

    Haifa

  • Chiesi Clinical Trial - Site 376403

    Jerusalem

  • Chiesi Clinical Trial - Site 376406

    Jerusalem

  • Chiesi Clinical Trial - Site 376407

    Kfar Saba

  • Chiesi Clinical Trial - Site 376405

    Petah Tikva

  • Chiesi Clinical Trial - Site 376404

    Ramat Gan

  • Chiesi Clinical Trial - Site 376409

    Tel Aviv

  • Chiesi Clinical Trial - Site 376451

    Tel Litwinsky

Other trials in Israel

Serbia10 sites

  • Kliničko Bolnički Centar Zvezdara - Site 688459

    Belgrade, 11050

  • Chiesi Clinical Trial - Site 688401

    Belgrade

  • Institut za Plućne Bolesti Sremska Kamenica - Site 688464

    Kamenitz, 21204

  • Institute for Pulmonary Diseases of Vojvodina - Site 688466

    Kamenitz, 21204

  • Klinički Centar Kragujevac - Site 688456

    Kragujevac, 34000

  • Chiesi Clinical Trial - Site 688402

    Kragujevac

  • Chiesi Clinical Trial - Site 688403

    Kruševac

  • Chiesi Clinical Trial - Site 688404

    Niš

  • Chiesi Clinical Trial - Site 688405

    Niš

  • Chiesi Clinical Trial - Site 688463

    Užice

Other trials in Serbia

Turkey (Türkiye)9 sites

  • Chiesi Clinical Trial - Site 792412

    Adana

  • Chiesi Clinical Trial - Site 792410

    Bornova

  • Chiesi Clinical Trial - Site 792415

    Çanakkale

  • Chiesi Clinical Trial - Site 792408

    Istanbul

  • Chiesi Clinical Trial - Site 792414

    Kocaeli

  • Chiesi Clinical Trial - Site 792413

    Mersin

  • Chiesi Clinical Trial - Site 792406

    Pamukkale

  • Chiesi Clinical Trial - Site 792411

    Yenişehir

  • Chiesi Clinical Trial - Site 792407

    Zeytinburnu

Other trials in Turkey (Türkiye)

North Macedonia8 sites

  • Chiesi Clinical Trial - Site 807402

    Gostivar

  • Chiesi Clinical Trial - Site 807401

    Prilep

  • Chiesi Clinical Trial - Site 807452

    Skopje

  • Chiesi Clinical Trial - Site 807454

    Skopje

  • General Hospital-Struga - Site 807405

    Struga, 6330

  • General Hospital-Strumica - Site 807406

    Strumica, 2400

  • Chiesi Clinical Trial - Site 807403

    Tetovo

  • General Hospital - Veles - Site 807404

    Veles, 1400

Other trials in North Macedonia

Georgia7 sites

  • Chiesi Clinical Trial - Site 268451

    Tbilisi

  • Chiesi Clinical Trial - Site 268452

    Tbilisi

  • Chiesi Clinical Trial - Site 268453

    Tbilisi

  • Chiesi Clinical Trial - Site 268454

    Tbilisi

  • Chiesi Clinical Trial - Site 268455

    Tbilisi

  • Chiesi Clinical Trial - Site 268456

    Tbilisi

  • Chiesi Clinical Trial - Site 268457

    Tbilisi

Other trials in Georgia

South Africa7 sites

  • Chiesi Clinical Trial - Site 710458

    Benoni

  • Chiesi Clinical Trial - Site 710451

    Bloemfontein

  • Chiesi Clinical Trial - Site 710456

    Centurion

  • Chiesi Clinical Trial - Site 710454

    Durban

  • Chiesi Clinical Trial - Site 710455

    George

  • Chiesi Clinical Trial - Site 710453

    Johannesburg

  • Chiesi Clinical Trial - Site 710452

    Pretoria

Other trials in South Africa

Australia6 sites

  • Chiesi Clinical Trial - Site 36453

    Adelaide

  • Chiesi Clinical Trial - Site 36454

    Box Hill

  • Chiesi Clinical Trial - Site 36455

    Campbelltown

  • Chiesi Clinical Trial - Site 36456

    Clayton

  • Chiesi Clinical Trial - Site 36451

    South Brisbane

  • Chiesi Clinical Trial - Site 36452

    Westmead

Other trials in Australia

Austria6 sites

  • Chiesi Clinical Trial - Site 40402

    Feldbach

  • Chiesi Clinical Trial - Site 40404

    Grieskirchen

  • Chiesi Clinical Trial - Site 40406

    Linz, 4020

  • Chiesi Clinical Trial - Site 40401

    Linz

  • Chiesi Clinical Trial - Site 40403

    Linz

  • Chiesi Clinical Trial - Site 40405

    Wels, 4600

Other trials in Austria

Chile6 sites

  • Chiesi Clinical Trial - Site 152406

    Concepción

  • Chiesi Clinical Trial - Site 152407

    Quillota

  • Chiesi Clinical Trial - Site 152403

    Santiago

  • Chiesi Clinical Trial - Site 152404

    Santiago

  • Chiesi Clinical Trial - Site 152409

    Talca

  • Chiesi Clinical Trial - Site 152401

    Valparaíso

Other trials in Chile

Greece6 sites

  • Chiesi Clinical Trial - Site 300406

    Athens

  • Chiesi Clinical Trial - Site 300401

    Heraklion

  • Chiesi Clinical Trial - Site 300403

    Ioannina

  • Chiesi Clinical Trial - Site 300404

    Thessaloniki

  • Chiesi Clinical Trial - Site 300405

    Thessaloniki

  • Chiesi Clinical Trial - Site 300407

    Volos

Other trials in Greece

Italy5 sites

  • Chiesi Clinical Trial - Site 380454

    Brescia

  • Chiesi Clinical Trial - Site 380451

    Catania

  • Chiesi Clinical Trial - Site 380453

    Ferrara

  • Chiesi Clinical Trial - Site 380455

    Roma

  • Chiesi Clinical Trial - Site 380452

    Trieste

Other trials in Italy

Netherlands5 sites

  • Chiesi Clinical Trial - Site 528403

    Almere Stad

  • Chiesi Clinical Trial - Site 528401

    Beek

  • Chiesi Clinical Trial - Site 528404

    Breda

  • Chiesi Clinical Trial - Site 528402

    Heerlen

  • Chiesi Clinical Trial - Site 528405

    Leeuwarden

Other trials in Netherlands

Slovakia5 sites

  • Chiesi Clinical Trial - Site 703401

    Bardejov

  • Chiesi Clinical Trial - Site 703452

    Humenné

  • Chiesi Clinical Trial - Site 703403

    Košice

  • Chiesi Clinical Trial - Site 703453

    Levice

  • Chiesi Clinical Trial - Site 703402

    Spišská Nová Ves

Other trials in Slovakia

United Kingdom4 sites

  • Chiesi Clinical Trial - Site 826410

    Belfast

  • Chiesi Clinical Trial - Site 826409

    Bradford

  • Chiesi Clinical Trial - Site 826411

    London

  • Chiesi Clinical Trial - Site 826412

    Rochdale

Other trials in United Kingdom

New Zealand3 sites

  • Chiesi Clinical Trial - Site 554404

    Christchurch

  • Chiesi Clinical Trial - Site 554402

    Hamilton

  • Chiesi Clinical Trial - Site 554406

    Wellington

Other trials in New Zealand

About this study

Official title: A 52-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI add-on to Maintenance Triple Therapy in Subjects With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Bronchitis

The purpose of the study is to evaluate the efficacy and safety of two doses of CHF6001 (Tanimilast), as add-on to maintenance triple therapy in the target patient population.

Being tested
Experimental: CHF6001 1600µg, Experimental: CHF6001 3200µg, Placebo
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.

  • Experimental: CHF6001 1600µgDrug

    CHF6001 400µg, 2 inhalations bid (total daily dose of 1600µg).

  • Experimental: CHF6001 3200µgDrug

    CHF6001 800µg, 2 inhalations bid (total daily dose of 3200µg).

  • PlaceboDrug

    CHF6001 matching placebo, 2 inhalations bid.

Study groups in NCT04636801
Study groupRoleWhat they receive
CHF6001 1600µgExperimentalNot described
Receives: Drug: Experimental: CHF6001 1600µg
CHF6001 3200µgExperimentalNot described
Receives: Drug: Experimental: CHF6001 3200µg
CHF6001 PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. The number of moderate and severe COPD 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 corticosteroid (oral/IV/IM corticosteroids), and/or use of antibiotics
    • Severe: requiring hospitalisation or resulting in death

    Measured: Up to 52 weeks

Secondary outcomes (12)

  1. The time to first moderate or severe exacerbation.

    Measured: Up to 52 weeks

  2. The annual rate of severe exacerbation.

    Measured: Up to 52 weeks

  3. The time to first severe exacerbation.

    Measured: Up to 52 weeks

  4. The number of on-treatment severe exacerbations.

    Measured: Up to 52 weeks

  5. Change from baseline (pre-dose visit 2) in pre-dose FEV1 at week 52.

    Measured: At Week 52

  6. Change from baseline in SGRQ total and domain scores at week 52.

    Measured: At week 52

  7. SGRQ response (change from baseline SGRQ total score ≤ -4) at week 52.

    Measured: At week 52

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

    Measured: Up to 52 weeks

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

    Measured: At week 52

  10. 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)

    Measured: Up to 52 weeks

  11. Time to study medication discontinuation for any reason.

    Measured: Up to 52 weeks

  12. 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

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 start14 Jul 2021
  3. Primary completion31 Oct 2025
  4. Study completion31 Oct 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
4,710 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04636801
Sponsor's protocol ID
CLI-06001AA1-04
Other IDs
2020-003666-40
Acronym
PILASTER
Status last verified
Dec 2025
First submitted
16 Nov 2020
Last updated
17 Dec 2025
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 Experimental: CHF6001 1600µg and Experimental: CHF6001 3200µg in people with Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 447 sites in 30 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 12 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 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 447 sites in China, Ukraine, Russia, Bulgaria, Argentina and 25 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 COPD 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 NCT04636801.

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 17 Dec 2025.

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