Study Investigating the Effect of 4 Doses of RPL554 Given in Addition to Tiotropium to Patients With COPD

PHASE2CompletedINTERVENTIONAL
Enrollment

416

Participants

Timeline

Start Date

May 1, 2019

Primary Completion Date

November 15, 2019

Study Completion Date

November 15, 2019

Conditions
COPD
Interventions
DRUG

Ensifentrine (formerly RPL554) 0.375 mg twice daily plus placebo, in addition to tiotropium

"Patients will be randomized to receive one of the following treatment arms plus tiotropiuim:~● RPL554 0.375 mg twice daily The approximate planned duration for each completed patient will be 14 days of run-in and 28 days of treatment with study medication."

DRUG

Ensifentrine (formerly RPL554) 0.75 mg twice daily plus placebo, in addition to tiotropium

"Patients will be randomized to receive one of the following treatment arms plus tiotropiuim:~● RPL554 0.75 mg twice daily The approximate planned duration for each completed patient will be 14 days of run-in and 28 days of treatment with study medication."

DRUG

Ensifentrine (formerly RPL554) 1.5 mg twice daily plus placebo, in addition to tiotropium

"Patients will be randomized to receive one of the following treatment arms plus tiotropiuim:~● RPL554 1.5 mg twice daily The approximate planned duration for each completed patient will be 14 days of run-in and 28 days of treatment with study medication."

DRUG

Ensifentrine (formerly RPL554) 3.0 mg twice daily plus placebo, in addition to tiotropium

"Patients will be randomized to receive one of the following treatment arms plus tiotropiuim:~● RPL554 3.0 mg twice daily The approximate planned duration for each completed patient will be 14 days of run-in and 28 days of treatment with study medication."

DRUG

Ensifentrine (formerly RPL554) placebo twice daily, in addition to tiotropium

"Patients will be randomized to receive one of the following treatment arms plus tiotropiuim:~● Placebo twice daily The approximate planned duration for each completed patient will be 14 days of run-in and 28 days of treatment with study medication."

Trial Locations (50)

28054

Clinical Research of Gastonia, Gastonia

28078

American Health Research, Charlotte

Research Carolina of Huntersville, Huntersville

28117

Clinical Research of Lake Norman, Mooresville

29301

Fusion Clinical Research of Spartanburg, LLC, Spartanburg

Spartanburg Medical Research, Spartanburg

29303

Vitalink Research-Spartanburg, Spartanburg

29340

VitaLink Research-Gaffney, Gaffney

29379

VitaLink Research - Union, Union

29406

Lowcountry Lung and Critical Care, PA, Charleston

29464

Clinical Research of Charleston, Mt. Pleasant

29615

VitaLink Research-Greenville, Greenville

VitaLink Research-UPSTATE, Greenville

29621

Vitalink Research - Anderson, Anderson

29640

VitaLink Research - Easley, Easley

29678

Vitalink Research-Seneca, Seneca

29707

Piedmont Research Partners, LLC, Fort Mill

29732

Clinical Research of Rock Hill, Rock Hill

30019

VitaLink Research - Hamilton Mill, Dacula

30046

Gwinnett Biomedical Research, Lawrenceville

30096

VitaLink Research - Duluth, Duluth

30680

Vitalink, Winder

31326

IACT Health, Rincon

31904

Columbus Regional Research Institute, Columbus

32127

Progressive Medical Research, Port Orange

32174

Peninsula Research, Ormond Beach, LLC, Ormond Beach

32789

Florida Pulmonary Research Institute, LLC, Winter Park

33186

Clinical Trials of Florida, LLC, Miami

33511

Meris Clinical Research, Brandon

33707

Pasadena Center for Medical Research, LLC, St. Petersburg

33765

Clinical Research of West Florida, Clearwater

VitaLink-Columbia, Columbia

33952

Medsol Clinical Research Center, Inc, Port Charlotte

34741

Pulmonary Disease Specialists, PA d/b/a PDS Research, Kissimmee

Cities Research Center, Fridley

34748

Medical Research of Central Florida, LLC, Leesburg

36207

Pinnacle Research Group, LLC, Anniston

37909

New Phase Research & Development, Knoxville

43016

Aventiv Research, Inc, Dublin

43213

Aventiv Research, Inc, Columbus

45242

New Horizons Clinical Research, Cincinnati

48336

Pulmonary Research Institute of Southeast Michigan, Farmington Hills

75069

Metroplex Pulmonary and Sleep Center, McKinney

75605

DCOL Center for Clinical Research, Longview

76550

FMC Science, LLC, Lampasas

80026

Innovative Clinical Research, Lafayette

90048

Southern California Institute For Respiratory Diseases, Inc., Los Angeles

92835

California Research Medical Group, Inc, Fullerton

97504

Crisor, LLC, Medford

02723

Genesis Clinical Research and Consulting, LLC, Fall River

All Listed Sponsors
collaborator

Iqvia Pty Ltd

INDUSTRY

collaborator

LGC Limited

INDUSTRY

lead

Verona Pharma plc

INDUSTRY

NCT03937479 - Study Investigating the Effect of 4 Doses of RPL554 Given in Addition to Tiotropium to Patients With COPD | Biotech Hunter | Biotech Hunter