Efficacy and Safety Trial of 12 Weeks of Treatment With Nebulized SUN-101 in Patients With COPD (GOLDEN-4)

PHASE3CompletedINTERVENTIONAL
Enrollment

641

Participants

Timeline

Start Date

February 28, 2015

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2015

Conditions
COPDChronic Obstructive Pulmonary Disease
Interventions
DRUG

SUN-101 50 mcg BID eFlow (CS) nebulizer

SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer

DRUG

SUN-101 25 mcg BID eFlow (CS) nebulizer

SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer

DRUG

Placebo eFlow (CS) nebulizer

Placebo BID eFlow (R) Closed System (CS) nebulizer

Trial Locations (45)

23229

Pulmonary Associates of Richmond, Inc, Richmond

23606

Health Research of Hampton Roads, Inc., Newport News

27103

Southeastern Research Center, LLC, Winston-Salem

27408

PharmQuest, Greensboro

27609

PMG Research of Raleigh, LLC, Raleigh

28054

Clinical Research of Gastonia, Gastonia

28078

Clinical Research of Lake Norman, Huntersville

29340

Gaffney Pharmaceutical Research, Gaffney

29341

Spectrum Medical Research, LLC, Gaffney

29406

Lowcountry Lung and Critical Care, PA, Charleston

29464

Clinical Research of Charleston, Mt. Pleasant

29640

Easley Clinical Research, Easley

29678

Hope Clinical Research, Seneca

29732

CU Pharmaceutical Research, Rock Hill

30096

Duluth Biomedical Research, LLC, Duluth

30331

Atlanta Center for Medical Research, Atlanta

31326

Southeast Regional Research Group, Rincon

32127

Progressive Medical Research, Port Orange

32174

Ribo Research, LLC dba Peninsula Research Inc., Ormond Beach

32789

Pulmonary Care Research Group, PA, Winter Park

35501

Jasper Summit Research, LLC, Jasper

36420

SEC Lung, LLC, Andalusia

37919

New Phase Research & Development, Knoxville

43016

Sridhar Guduri, MD, Dublin

43215

Remington-Davis, Inc, Columbus

45242

New Horizons Clinical Research, Cincinnati

46360

LaPorte County Institute for Clinical Research, Michigan City

55407

Minnesota Lung Center, Minneapolis

58103

Liliestol Research LLC, Fargo

60305

Asthma and Allergy Center of Chicago, SC, River Forest

63141

CAR.E. Clinical Research, St Louis

The Clinical Research Center, LLC, St Louis

70115

George Stanley Walker, MD, New Orleans

73103

IPS Research Company, Oklahoma City

80023

Innovative Clinical Research, Broomfield

80112

IMMUNOe International Research Centers, Centennial

80501

Longmont Pulmonary and Critical Care, Longmont

85283

Clinical Research Consortium, Tempe

85306

Pulmonary Associates, PA, Glendale

85381

Phoenix Medical Research Institute, LLC, Peoria

92120

Institute of HealthCare Assessment, Inc, San Diego

95823

Center for Clinical Trials of Sacramento, Inc., Sacramento

97202

Allergy Associates Research Center, Portland

98405

Multicare Pulmonary Specialists, Tacoma

08053

Delaware Valley Clinical Research, Marlton

All Listed Sponsors
lead

Sunovion Respiratory Development Inc.

INDUSTRY

NCT02347774 - Efficacy and Safety Trial of 12 Weeks of Treatment With Nebulized SUN-101 in Patients With COPD (GOLDEN-4) | Biotech Hunter | Biotech Hunter