A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD

PHASE3CompletedINTERVENTIONAL
Enrollment

763

Participants

Timeline

Start Date

September 29, 2020

Primary Completion Date

September 12, 2022

Study Completion Date

December 2, 2022

Conditions
Chronic Obstructive Pulmonary Disease
Interventions
DRUG

Ensifentrine

Dosage Formulation: Ensifentrine Nebulizer suspension Dosage 3mg Frequency: Twice Daily for 24 weeks or 48 weeks

DRUG

Placebo

Dosage Formulation: Ensifentrine Placebo Nebulizer solution Frequency: Twice Daily for 24 weeks or 48 weeks

Trial Locations (122)

1033

Clinexpert Kft., Budapest

1510

Medical Center Hera EOOD, Sofia

2200

Bajcsy-Zsilinszky Kórház és Rendelőintézet Monori Rendelőintézete, Monor

3700

"MC Sv. Ivan Rilski, OOD", Vidin

4003

UMHAT-Plovdiv AD, Plovdiv

4080

Szalay János Rendelőintézet Tüdőgyógyászati Szakrendelés, Hajdúnánás

4150

Püspökladányi Egészségügyi Szolgáltató Nonprofit Kft., Püspökladány

5800

Medical center Medconsult Pleven OOD, Pleven

6300

SHATPPD - Haskovo, EOOD, Haskovo

9200

Karolina Kórház-Rendelőintézet, Tüdőgyógyászat, Mosonmagyaróvár

9700

Markusovszky Egyetemi Oktatókórház Tüdőgondozó, Szombathely

10036

IMA Clinical Research, LLC, New York

10119

Studienpraxis Berlin-Brandenburg, Berlin

10625

Praxis an der Oper., Berlin

11527

"General Hospital of Athens of Chest Diseases SOTIRIA, 7th Respiratory Clinic", Athens

13187

Clinical Studies Pankow Dr Dr Evelin Liefring/Ishak Teber, Berlin

15213

University of Pittsburgh Physicians, Emphysema/COPD Research Center, Pittsburgh

15300

Plicni centrum s.r.o., Prague

15801

Clinical Research Associates of Central PA, LLC, DuBois

21224

John Hopkins University School of Medicine, Baltimore

22927

PRI Pulmonary Research Institute, Pneumologisches Forschungsinstitut GmbH, Großhansdorf

23188

TPMG Clinical Research Williamsburg, Williamsburg

23552

KLB Gesundheitsforschung Luebeck GmbH; Praxis Dr. med. Jens Becker, Lübeck

24210

Pulmonary Research of Abingdon, LLC, Abingdon

25001

MUDr. I. Cierna Peterova s.r.o., Brandýs nad Labem

28112

Monroe Biomedical Research, Monroe

29204

Medtrial, Columbia

29720

MDFirst Research, Lancaster

30024

In-Quest Medical Research, LLC, Suwanee

30030

iResearch Atlanta, LLC, Decatur

31224

Dr. Christian Schlenska, Peine

31326

IACT Health, Rincon

32055

Multi-Specialty Research Associates, Inc., Lake City

32825

Florida Institute for Clinical Research, Orlando

33010

Qway Research, LLC, Hialeah

33144

Elite Clinical Research, Miami

Global Research Solutions Corp, Miami

33165

Phoenix Medical Research, Miami

33351

Precision Clinical Research, Sunrise

33606

Clinical Research of West Florida, Inc., Tampa

33701

MUDr. Josef Veverka, Plicni ambulacne, Rokycany

33765

Clinical Research of West Florida, Inc., Clearwater

St. Francis Medical Institute, Clearwater

37404

Chattanooga Research & Medicine (CHARM), Chattanooga

37601

MultiSpecialty Clinical Research, Inc., Johnson City

37909

New Phase Research Development, Knoxville

39120

SMO.MD GmbH, Magdeburg

41002

CEFISPIRO s.r.o., Lovosice

41110

University General Hospital of Larissa, University Pulmonary Clinic, Larissa

41501

Plicni stredisko Teplice s.r.o., Teplice

42415

Yeungnam University Hospital, Daegu

43215

Remington Davis Clinical Research, Columbus

45500

University General Hospital of Ioannina, University Respiratory Clinic, Ioannina

48336

Pulmonary Research Institute of SE Michigan, Farmington Hills

48431

Framol-med GmbH, Pneumologische Gemeinschaftspraxis Rheine, Rheine

51069

Zentrum fur Klinische Forschung, Cologne

60389

Praxis Dr. Keller, Frankfurt am Main

60596

IKF Pneumologie GmbH & Co. KG, Frankfurt am Main

63141

The Clinical Research Center, LLC, St Louis

63263

Ballenberger, Freytag, Wenisch Institut für klinische Forschung, Neu-Isenburg

63301

Midwest Chest Consultants, Saint Charles

71110

University General Hospital of Heraklion, Pulmonary Clinic, Heraklion

74601

Odborná plicní ambulance Opava s.r.o., Opava

74801

MUDr. Petr Pravda, Hlučín

75092

Sherman Clinical Research, Sherman

77055

West Houston Clinical Research Services, Houston

77584

LinQ Research, LLC, Pearland

85281

AMR Tempe, Tempe

85381

Phoenix Medical Group, Peoria

89106

Sierra Clinical Research, Las Vegas

89119

Alliance for Multispecialty Research, LLC, Las Vegas

90017

Downtown LA Research Center, Inc., Los Angeles

92647

Beach Physicians Medical Group, Huntington Beach

97527

Velocity Clinical Research - Grants Pass, Grants Pass

150010

"SBHI of Yaroslavl Region Clinical Hospital # 2", Yaroslavl

150047

SBHI Outpatient 2, Yaroslavl

191180

"SPb SBHI Vvedenskaya hospital", Saint Petersburg

194156

"LEC at the LLC LLC Energiy Zdorovya", Saint Petersburg

196084

"LLC Institute of Medical Examinations", Saint Petersburg

196143

Research center Eco-safety, LLC, Saint Petersburg

197022

Pavlov First Saint Petersburg State Medical University, Saint Petersburg

197706

"SPb SBIH City Hospital # 40 of Kurortnyi region", Sestroretsk

300134

Fundatia Cardioprevent, Timișoara

300310

"Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes Timisoara", Timișoara

400371

S.C Cardiomed S.R.L, Cluj-Napoca

454091

"SBHI Regional Clinical Hospital #3", Chelyabinsk

500091

S.C Centrul Medical Unirea S.R.L, Campus Medical Brasov, Brasov

500283

S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L, Brasov

500366

"Spitalul Clinic de Pneumoftiziologie Leon Daniello Cluj-Napoca", Brasov

505100

Impatiens SRL, Codlea

620109

LLC MA New Hospital, Yekaterinburg

620149

City Hospital #6, Yekaterinburg

630007

"LLC Novosibirsk GastroCenter", Novosibirsk

630008

"SBIH of Novosibirsk Region Clinical Emergency Hospital #2", Novosibirsk

630075

City Clinical Hospital #25, Novosibirsk

650002

"FSBI Scientific-research Institute for Complex Problems of cardiovascular disease", Kemerovo

656038

"NSHI Departmental CH on St. Barnaul of JSCO Russian Railways", Barnaul

1500030

"SBHI of Yaroslavl Region Clinical Hospital # 2", Yaroslavl

625 00

Fakultni nemocnice Brno, Dept of Klinika nemoci plicnich a tuberkulozy, Brno

550 01

EDUMED s.r.o., Broumov

377 01

MediTrial s.r.o., Jindřichův Hradec

278 01

Plicni ambulance Kralupy s.r.o., Kralupy nad Vltavou

149 00

DAWON spol. s.r.o., Plicni ambulance, Prague

03050

MECS GmbH Cottbus, Cottbus

04157

Pneumologische Praxis Dr. Falk Brunner, Leipzig

04207

Salvus-Klinische Studien GmbH., Leipzig

85-231

NZOZ Centrum Medyczne KERmed, Bydgoszcz

80-214

Uniwersyteckie Centrum Kliniczne, Gdansk

20-552

Centrum Alergologii Sp. z o. o., Lublin

08-110

ETG Siedlce, Siedlce

87-100

NASZ LEKARZ Ośrodek Badań Klinicznych, Torun

02-793

ETG Warszawa, Warsaw

012071

Quantum Medical Center S.R.L., Bucharest

050159

"Institutul de Pneumoftiziologie Marius Nasta", Bucharest

08501

Nemocnica s poliklinikou Sv. Jakuba, n.o. Bardejov, Bardejov

06601

Inspiro, s.r.o., Humenné

05201

Plucna ambulancia Hrebenar, s.r.o., Spišská Nová Ves

02447

Kyung Hee University Hospital, Seoul

05505

Asan Medical Center, Seoul

06591

The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul

07345

The Catholic University of Korea, Yeouido St.Mary's Hospital, Seoul

W1T6AH

Respiratory Clinical Trials Ltd, London

All Listed Sponsors
collaborator

Iqvia Pty Ltd

INDUSTRY

lead

Verona Pharma plc

INDUSTRY

NCT04535986 - A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD | Biotech Hunter | Biotech Hunter