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A Long-Term Safety Trial of Treatment With Nebulized SUN-101 in Patients With COPD (GOLDEN-5)

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

SUN-101 50 mcg BID eFlow (CS) nebulizer

Spiriva® 18 mcg QD Handihaler

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Chronic Obstructive Pulmonary Disease, COPD

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female patients age ≥ 40 years, inclusive.
A clinical diagnosis of COPD according to the GOLD 2014 guidelines.
Current smokers or ex-smokers with at least 10 pack-year smoking history (eg, at least 1 pack/day for 10 years, or equivalent).
Post-bronchodilator (following inhalation of ipratropium bromide) FEV1 < 80% of predicted normal and > 0.7 L during Screening (Visit 1).
Post-bronchodilator (following inhalation of ipratropium bromide) FEV1/FVC ratio < 0.70 during Screening (Visit 1).
Ability to perform reproducible spirometry according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines (2005).
Subject, if female ≤ 65 years of age and of child bearing potential, must have a negative serum pregnancy test at Visit 1. Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control: a) an oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study with continued use throughout the study and for thirty days following participation; b) barrier method of contraception, e.g., condom and /or diaphragm with spermicide while participating in the study; and/or c) abstinence..
Willing and able to provide written informed consent.
Willing and able to attend all study visits and adhere to all study assessments and procedures.

Exclusion Criteria:

Severe comorbidities including unstable cardiac or pulmonary disease or any other medical conditions that would, in the opinion of the Investigator, preclude the subject from safely completing the required tests or the study, or is likely to result in disease progression that would require withdrawal of the subject.
Concomitant clinically significant respiratory disease other than COPD (eg, asthma, tuberculosis, bronchiectasis or other non-specific pulmonary disease).
Recent history of COPD exacerbation requiring hospitalization or need for increased treatments for COPD within 6 weeks prior to Screening (Visit 1).
Use of daily oxygen therapy > 12 hours per day.
Respiratory tract infection within 6 weeks prior to Screening (Visit 1).
Use of systemic steroids within 3 months prior to Screening (Visit 1).
History of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localized basal cell carcinoma of the skin.
Prolonged QTc (> 450 msec for males and > 470 msec for females) during Screening (Visit 1), or history of long QT syndrome.
History of or clinically significant ongoing bladder outflow obstruction or history of catheterization for relief of bladder outflow obstruction within the previous 6 months.
History of narrow angle glaucoma.
History of hypersensitivity or intolerance to aerosol medications.
Recent documented history (within the previous 3 months) of substance abuse.
Significant psychiatric disease that would likely result in the subject not being able to complete the study, in the opinion of the Investigator.
Participation in another investigational drug study where drug was received within 30 days prior to Screening (Visit 1) or current participation in another investigational drug trial, including a SUN-101 study.
Previously received SUN-101 (active treatment; formerly known as EP-101).
Contraindicated for treatment with, or having a history of reactions/ hypersensitivity to anticholinergic agents, beta2 agonists, or sympathomimetic amines.

Sites / Locations

SEC Lung LLC
Achieve Clinical Research LLC
Jasper Summit Research LLC
Clinical Research Advantage, Inc.lEast Valley Family Physicians, PLC
Desert Sun Clinical Research LLC
Allianz Research Institute, Inc.
Research Center of Fresno, Inc.
California Research Medical Group, lnc.
Southern California Institute For Respiratory Diseases, Inc.
Integrated Research Group, Inc
Institute of Healthcare Assessments Inc.
Waterbury Pulmonary Associates, LLC
Tampa Bay Clinical Research Center
Clinical Research of West Florida
Avail Clinical Research, llC
The Community Research of South Florida
AppleMed Research, Inc
Research Institute of South Florida, Inc
Clinical Trials of Florida, LLC
Florida Institute For Clinical Research, LLC
Ribo Research, LLC dba Peninsula Research, Inc.
Clinical Research of West Florida, Inc.
Clinical Research of West Florida
Vero Lung Center
Gwinnett Biomedical Research
H.C. Research LLC
Evanston Premier Healthcare Research LLC
Asthma and Allergy Center of Chicago SC
LaPorte County Institute For Clinical Research
Buynak Clinical Research, P.C.
Abraham Research, PLLC
Kentucky Lung Clinics, PSC
Bendel Medical Research Center, LLC
New Orleans Center for Clinical Research
Howard County Center for Lung and Sleep Medicine, LLC
Pulmonary and Critical Care Associates of Baltimore
Cadillac Clinical Research LLC
Pulmonary Research Institute of Southeast Michigan
Minnesota Lung Center
Clinical Research Institute, Inc.
Minnesota Lung Center
Minnesota Lung Center
Midwest Chest Consultants PC
CARE Clinical Research
Midwest Clinical Research LLC
The Clinical Research Center
Somnos Laboratories, Inc d/b/a Somnos Clinical Research
Clinical Research Advantage Inc
Delaware Valley Clinical Research, LLC
Atlantic Research Center, LLC
Pulmonary and Allergy Associates, PA
ISA Clinical Research
American Health Research, Inc.
ARSM Research
Clinical Research of Lake Norman
North Carolina Clinical Research
PMG Research of Wilmington, LLC
Southeastern Research Center
Lillestol Research, LLC
IVA Researcb
Remington Davis Inc
IPS Research Company
Clinical Research Institute of Southern Oregon, PC
Sunstone Medical Research, L.LC
Allergy Associates Research Center
Lowcountry Lung and Critical Care, PA
Easley Clinical Research
Palmetto Medical Research Associates
Gaffney Pharmaceutical Research
Spectrum Medical Research, LLC
Greenville Pharmaceutical Research, Inc.
Upstate Pharmaceutical Research, Inc.
DeGarmo Institute of Medical Research
Clinical Research of Charleston
Hope Clinical Research
S. Carolina Pharmaceutical Research
Spartanburg Medical Research
CU Pharmaceutical Research
New Phase Clinical Research & Development
Corsicana Medical Research, PLLC
Pioneer Research Solutions, Inc
Alamo Clinical Research Associates
Pulmonary Consultants PLLC
Medicentrum Beroun s.r o.
MediTrial, s.r.o Internf a pneumoloqicka ambulance
Nemocnice Kyjov, p.o.
Plicni ambulance
MephaCentrum, a s Plicni oddeleni
MephaCentrum, a.s.
PNEUMa-HOST s LO.
PLiCNI AMBULANCE ROKYCANY, s.r o.
Hrudnf ambulance s.r.o.
Dr. Kenessey Albert Korhaz-Rendetointezet, TOd6gy6gyaszati
Csornai Margit Korhaz, TOd6gy6gyaszat
Kenezy Gyula Korhaz es Rendelomtezet, Klinikai Farmakologiai
Veszprern Megyei Tudbgyogyintezet
Somogy Megyei Kaposi M6r Oktat6 Korhaz, Tudoqondozo
Lumniczer Sandor Korhaz as Rendelointezet, Tudoqondozo
Selye Janos Korhaz es Rendelointezet, Tud6gy6gyaszati Szakrendeles
Szakorvosi Rendelointezet Monor, Tudoqondozo
Revamed Eqeszsequqyi Szolqaltato Kft.
Si6fok Kornaz-Rendelointezet, Tudoqondozo
Farmakontroll Egeszsegugyi Szolqaltato Bt
Csonqrad Megyei Mellkasi Beteqseqek Szakkorhaza, Tudoqondozo lntezet
Territorial SBI of Healthcare <Territorial Clinical Hospital>
FSBI Far Eastern Research Centre ofPhysiology and Pathology of Breathing of Siberian branch of RAMS
SBI of Healthcare Regional Clinical Hospital #4 City consultative department for pulmonological patientsr
Municipal Autonomous Institution (City ClinicalHospital #14)
Municipal Budget Institution of Healthcare (City Clinical Hospital #3 n.a. M.A. Podgorbunsky)
FSSI Scientific Research Institute of Complex Cardiovascular Pathology
FSBI
Non-State Private Institution of Healthcare <Scientific Clinical Center>
SBI of Healthcare of Nizhny-Novgorod region
SB1 of Healthcare of Novosibirsk region <Novosibirsk State Regional Clinical Hospital>l
SBI of Healthcare of Novosibirsk region <Novosibirsk State Regional Clinical Hospital>
SBEI of HPE <North-West State Medical University n.a. LL Mechnikov>
Alliance Biomedical, Russian Group LLC
SBr of Helathcareof Yaraslavl region Clinical Hospital of Emervency care n.a.N.V. Solovyev

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SUN-101 50 mcg BID eFlow (CS) nebulizer

Spiriva 18 mcg QD Handihaler

Arm Description

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

Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

Outcomes

Primary Outcome Measures

Number of Subjects With Treatment-emergent Adverse Events (TEAE)

A TEAE is any adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date.

Percentage of Subjects With Treatment-emergent Adverse Events

Number of Subjects With Treatment-emergent Serious Adverse Events (SAE)

A treatment emergent serious adverse event (SAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.

Percentage of Subjects With Treatment-emergent Serious Adverse

Number of Subjects Who Discontinue the Study Due to TEAE

Percentage of Subjects Who Discontinue the Study Due to TEAE

Secondary Outcome Measures

Number of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke

All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs "myocardial infarction", "other ischemic heart disease", "central nervous system hemorrhages and cerebrovascular conditions") were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected from the first date of study medication until the date of last contact.

Percentage of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke

Incidence Rate Per 1000 Person Years of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke

Mean Change From Baseline Over 48 Weeks in Trough FEV1 for All Subjects

Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the average of the FEV1 values collected at the end of the dosing interval at each clinic visit. The mean change from baseline in trough FEV1 over the 48 week treatment period is calculated by averaging the trough FEV1 changes from baseline across all study visits while subjects are taking randomized treatment. Values affected by other medication use were to be set to missing.

Full Information

NCT ID

NCT02276222

First Posted

October 14, 2014

Last Updated

February 13, 2018

Sponsor

Sunovion Respiratory Development Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02276222

Brief Title

A Long-Term Safety Trial of Treatment With Nebulized SUN-101 in Patients With COPD

Acronym

GOLDEN-5

Official Title

A Randomized, Open-Label, Active-Controlled, Parallel-Group, Multicenter, Long-Term Safety Trial of Treatment With Nebulized SUN-101 in Patients With COPD: GOLDEN-5 (Glycopyrrolate for Obstructive Lung Disease Via Electronic Nebulizer)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

October 2014 (undefined)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sunovion Respiratory Development Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a long-term safety trial of 48 weeks. Eligible subjects will enter the 48-week, open-label treatment period to receive one of two treatments (SUN-101 given as 50 mcg twice a day or Spiriva® [tiotropium] given as 18 mcg once a day).

Detailed Description

This is a Phase 3, randomized, open-label, active-controlled, parallel-group, multicenter, long-term safety trial of 48 weeks of treatment with nebulized SUN-101 using an Investigational eFlow® Closed System (CS) nebulizer or Spiriva in approximately 1050 subjects with chronic obstructive pulmonary disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD 2014) guidelines. Eligible subjects will enter the 48-week, open-label treatment period following randomization to receive one of two treatments (SUN-101 given as 50 mcg BID or Spiriva® [tiotropium] given as 18 mcg QD). The hypothesis for this study is that the incidence of treatment-emergent adverse events reported over the course of 48 weeks of treatment by subjects randomized to SUN-101 is numerically similar to the incidence of treatment-emergent adverse events reported over the course of 48 weeks of treatment by subject randomized to Spiriva (tiotropium).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic Obstructive Pulmonary Disease, COPD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1087 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SUN-101 50 mcg BID eFlow (CS) nebulizer

Arm Type

Experimental

Arm Description

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

Arm Title

Spiriva 18 mcg QD Handihaler

Arm Type

Active Comparator

Arm Description

Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

Intervention Type

Drug

Intervention Name(s)

SUN-101 50 mcg BID eFlow (CS) nebulizer

Other Intervention Name(s)

Glycopyrrolate

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Spiriva® 18 mcg QD Handihaler

Other Intervention Name(s)

(tiotropium)

Intervention Description

Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

Primary Outcome Measure Information:

Title

Number of Subjects With Treatment-emergent Adverse Events (TEAE)

Description

Time Frame

Up to Week 48

Title

Percentage of Subjects With Treatment-emergent Adverse Events

Description

Time Frame

Up to Week 48

Title

Number of Subjects With Treatment-emergent Serious Adverse Events (SAE)

Description

Time Frame

Up to Week 48

Title

Percentage of Subjects With Treatment-emergent Serious Adverse

Description

Time Frame

Up to Week 48

Title

Number of Subjects Who Discontinue the Study Due to TEAE

Description

Time Frame

Up to Week 48

Title

Percentage of Subjects Who Discontinue the Study Due to TEAE

Description

Time Frame

Up to 48 Weeks

Secondary Outcome Measure Information:

Title

Number of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke

Description

Time Frame

Up to Week 48

Title

Percentage of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke

Description

Time Frame

Up to 48 Weeks

Title

Incidence Rate Per 1000 Person Years of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke

Description

Time Frame

up to week 48

Title

Mean Change From Baseline Over 48 Weeks in Trough FEV1 for All Subjects

Description

Time Frame

Up to Week 48

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female patients age ≥ 40 years, inclusive. A clinical diagnosis of COPD according to the GOLD 2014 guidelines. Current smokers or ex-smokers with at least 10 pack-year smoking history (eg, at least 1 pack/day for 10 years, or equivalent). Post-bronchodilator (following inhalation of ipratropium bromide) FEV1 < 80% of predicted normal and > 0.7 L during Screening (Visit 1). Post-bronchodilator (following inhalation of ipratropium bromide) FEV1/FVC ratio < 0.70 during Screening (Visit 1). Ability to perform reproducible spirometry according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines (2005). Subject, if female ≤ 65 years of age and of child bearing potential, must have a negative serum pregnancy test at Visit 1. Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control: a) an oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study with continued use throughout the study and for thirty days following participation; b) barrier method of contraception, e.g., condom and /or diaphragm with spermicide while participating in the study; and/or c) abstinence.. Willing and able to provide written informed consent. Willing and able to attend all study visits and adhere to all study assessments and procedures. Exclusion Criteria: Severe comorbidities including unstable cardiac or pulmonary disease or any other medical conditions that would, in the opinion of the Investigator, preclude the subject from safely completing the required tests or the study, or is likely to result in disease progression that would require withdrawal of the subject. Concomitant clinically significant respiratory disease other than COPD (eg, asthma, tuberculosis, bronchiectasis or other non-specific pulmonary disease). Recent history of COPD exacerbation requiring hospitalization or need for increased treatments for COPD within 6 weeks prior to Screening (Visit 1). Use of daily oxygen therapy > 12 hours per day. Respiratory tract infection within 6 weeks prior to Screening (Visit 1). Use of systemic steroids within 3 months prior to Screening (Visit 1). History of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localized basal cell carcinoma of the skin. Prolonged QTc (> 450 msec for males and > 470 msec for females) during Screening (Visit 1), or history of long QT syndrome. History of or clinically significant ongoing bladder outflow obstruction or history of catheterization for relief of bladder outflow obstruction within the previous 6 months. History of narrow angle glaucoma. History of hypersensitivity or intolerance to aerosol medications. Recent documented history (within the previous 3 months) of substance abuse. Significant psychiatric disease that would likely result in the subject not being able to complete the study, in the opinion of the Investigator. Participation in another investigational drug study where drug was received within 30 days prior to Screening (Visit 1) or current participation in another investigational drug trial, including a SUN-101 study. Previously received SUN-101 (active treatment; formerly known as EP-101). Contraindicated for treatment with, or having a history of reactions/ hypersensitivity to anticholinergic agents, beta2 agonists, or sympathomimetic amines.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Respiratory Medical Director

Organizational Affiliation

Sunovion Respiratory Development

Official's Role

Study Director

Facility Information:

Facility Name

SEC Lung LLC

City

Andalusia

State/Province

Alabama

ZIP/Postal Code

36420

Country

United States

Facility Name

Achieve Clinical Research LLC

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35216

Country

United States

Facility Name

Jasper Summit Research LLC

City

Jasper

State/Province

Alabama

ZIP/Postal Code

35501

Country

United States

Facility Name

Clinical Research Advantage, Inc.lEast Valley Family Physicians, PLC

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

Facility Name

Desert Sun Clinical Research LLC

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85710

Country

United States

Facility Name

Allianz Research Institute, Inc.

City

Fountain Valley

State/Province

California

ZIP/Postal Code

92708

Country

United States

Facility Name

Research Center of Fresno, Inc.

City

Fresno

State/Province

California

ZIP/Postal Code

93702

Country

United States

Facility Name

California Research Medical Group, lnc.

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

Southern California Institute For Respiratory Diseases, Inc.

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

Integrated Research Group, Inc

City

Riverside

State/Province

California

ZIP/Postal Code

92506

Country

United States

Facility Name

Institute of Healthcare Assessments Inc.

City

San Diego

State/Province

California

ZIP/Postal Code

92120

Country

United States

Facility Name

Waterbury Pulmonary Associates, LLC

City

Waterbury

State/Province

Connecticut

ZIP/Postal Code

06708

Country

United States

Facility Name

Tampa Bay Clinical Research Center

City

Brandon

State/Province

Florida

ZIP/Postal Code

33511

Country

United States

Facility Name

Clinical Research of West Florida

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33765

Country

United States

Facility Name

Avail Clinical Research, llC

City

DeLand

State/Province

Florida

ZIP/Postal Code

32720

Country

United States

Facility Name

The Community Research of South Florida

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33016

Country

United States

Facility Name

AppleMed Research, Inc

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

Facility Name

Research Institute of South Florida, Inc

City

Miami

State/Province

Florida

ZIP/Postal Code

33173

Country

United States

Facility Name

Clinical Trials of Florida, LLC

City

Miami

State/Province

Florida

ZIP/Postal Code

33186

Country

United States

Facility Name

Florida Institute For Clinical Research, LLC

City

Orlando

State/Province

Florida

ZIP/Postal Code

32825

Country

United States

Facility Name

Ribo Research, LLC dba Peninsula Research, Inc.

City

Ormond Beach

State/Province

Florida

ZIP/Postal Code

32174

Country

United States

Facility Name

Clinical Research of West Florida, Inc.

City

Tampa

State/Province

Florida

ZIP/Postal Code

33603

Country

United States

Facility Name

Clinical Research of West Florida

City

Tampa

State/Province

Florida

ZIP/Postal Code

33603

Country

United States

Facility Name

Vero Lung Center

City

Vero Beach

State/Province

Florida

ZIP/Postal Code

32960

Country

United States

Facility Name

Gwinnett Biomedical Research

City

Lawrenceville

State/Province

Georgia

ZIP/Postal Code

30046

Country

United States

Facility Name

H.C. Research LLC

City

Coeur d'Alene

State/Province

Idaho

ZIP/Postal Code

83814

Country

United States

Facility Name

Evanston Premier Healthcare Research LLC

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Facility Name

Asthma and Allergy Center of Chicago SC

City

River Forest

State/Province

Illinois

ZIP/Postal Code

60305

Country

United States

Facility Name

LaPorte County Institute For Clinical Research

City

Michigan City

State/Province

Indiana

ZIP/Postal Code

46360

Country

United States

Facility Name

Buynak Clinical Research, P.C.

City

Valparaiso

State/Province

Indiana

ZIP/Postal Code

46383

Country

United States

Facility Name

Abraham Research, PLLC

City

Fort Mitchell

State/Province

Kentucky

ZIP/Postal Code

41017

Country

United States

Facility Name

Kentucky Lung Clinics, PSC

City

Hazard

State/Province

Kentucky

ZIP/Postal Code

41701

Country

United States

Facility Name

Bendel Medical Research Center, LLC

City

Lafayette

State/Province

Louisiana

ZIP/Postal Code

70508

Country

United States

Facility Name

New Orleans Center for Clinical Research

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70119

Country

United States

Facility Name

Howard County Center for Lung and Sleep Medicine, LLC

City

Columbia

State/Province

Maryland

ZIP/Postal Code

21044

Country

United States

Facility Name

Pulmonary and Critical Care Associates of Baltimore

City

Towson

State/Province

Maryland

ZIP/Postal Code

21204

Country

United States

Facility Name

Cadillac Clinical Research LLC

City

Cadillac

State/Province

Michigan

ZIP/Postal Code

49601

Country

United States

Facility Name

Pulmonary Research Institute of Southeast Michigan

City

Livonia

State/Province

Michigan

ZIP/Postal Code

48152

Country

United States

Facility Name

Minnesota Lung Center

City

Edina

State/Province

Minnesota

ZIP/Postal Code

55435

Country

United States

Facility Name

Clinical Research Institute, Inc.

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55402

Country

United States

Facility Name

Minnesota Lung Center

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55407

Country

United States

Facility Name

Minnesota Lung Center

City

Woodbury

State/Province

Minnesota

ZIP/Postal Code

55125

Country

United States

Facility Name

Midwest Chest Consultants PC

City

Saint Charles

State/Province

Missouri

ZIP/Postal Code

63301

Country

United States

Facility Name

CARE Clinical Research

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Midwest Clinical Research LLC

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

The Clinical Research Center

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Somnos Laboratories, Inc d/b/a Somnos Clinical Research

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68510

Country

United States

Facility Name

Clinical Research Advantage Inc

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89128

Country

United States

Facility Name

Delaware Valley Clinical Research, LLC

City

Marlton

State/Province

New Jersey

ZIP/Postal Code

08053

Country

United States

Facility Name

Atlantic Research Center, LLC

City

Ocean City

State/Province

New Jersey

ZIP/Postal Code

07712

Country

United States

Facility Name

Pulmonary and Allergy Associates, PA

City

Summit

State/Province

New Jersey

ZIP/Postal Code

07901

Country

United States

Facility Name

ISA Clinical Research

City

Jamaica

State/Province

New York

ZIP/Postal Code

11435

Country

United States

Facility Name

American Health Research, Inc.

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28207

Country

United States

Facility Name

ARSM Research

City

Huntersville

State/Province

North Carolina

ZIP/Postal Code

28078

Country

United States

Facility Name

Clinical Research of Lake Norman

City

Huntersville

State/Province

North Carolina

ZIP/Postal Code

28078

Country

United States

Facility Name

North Carolina Clinical Research

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27607

Country

United States

Facility Name

PMG Research of Wilmington, LLC

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

Southeastern Research Center

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Lillestol Research, LLC

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58103

Country

United States

Facility Name

IVA Researcb

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45245

Country

United States

Facility Name

Remington Davis Inc

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43215

Country

United States

Facility Name

IPS Research Company

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Clinical Research Institute of Southern Oregon, PC

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504

Country

United States

Facility Name

Sunstone Medical Research, L.LC

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504

Country

United States

Facility Name

Allergy Associates Research Center

City

Portland

State/Province

Oregon

ZIP/Postal Code

97202

Country

United States

Facility Name

Lowcountry Lung and Critical Care, PA

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29406

Country

United States

Facility Name

Easley Clinical Research

City

Easley

State/Province

South Carolina

ZIP/Postal Code

29640

Country

United States

Facility Name

Palmetto Medical Research Associates

City

Easley

State/Province

South Carolina

ZIP/Postal Code

29640

Country

United States

Facility Name

Gaffney Pharmaceutical Research

City

Gaffney

State/Province

South Carolina

ZIP/Postal Code

29340

Country

United States

Facility Name

Spectrum Medical Research, LLC

City

Gaffney

State/Province

South Carolina

ZIP/Postal Code

29341

Country

United States

Facility Name

Greenville Pharmaceutical Research, Inc.

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29615

Country

United States

Facility Name

Upstate Pharmaceutical Research, Inc.

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29615

Country

United States

Facility Name

DeGarmo Institute of Medical Research

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29651

Country

United States

Facility Name

Clinical Research of Charleston

City

Mount Pleasant

State/Province

South Carolina

ZIP/Postal Code

29464

Country

United States

Facility Name

Hope Clinical Research

City

Seneca

State/Province

South Carolina

ZIP/Postal Code

29678

Country

United States

Facility Name

S. Carolina Pharmaceutical Research

City

Spartanburg

State/Province

South Carolina

ZIP/Postal Code

29303

Country

United States

Facility Name

Spartanburg Medical Research

City

Spartanburg

State/Province

South Carolina

ZIP/Postal Code

29303

Country

United States

Facility Name

CU Pharmaceutical Research

City

Union

State/Province

South Carolina

ZIP/Postal Code

29379

Country

United States

Facility Name

New Phase Clinical Research & Development

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37919

Country

United States

Facility Name

Corsicana Medical Research, PLLC

City

Corsicana

State/Province

Texas

ZIP/Postal Code

75110

Country

United States

Facility Name

Pioneer Research Solutions, Inc

City

Houston

State/Province

Texas

ZIP/Postal Code

77099

Country

United States

Facility Name

Alamo Clinical Research Associates

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78212

Country

United States

Facility Name

Pulmonary Consultants PLLC

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

Medicentrum Beroun s.r o.

City

Beroun

ZIP/Postal Code

266 01

Country

Czechia

Facility Name

MediTrial, s.r.o Internf a pneumoloqicka ambulance

City

Jindřichův Hradec

ZIP/Postal Code

377 01

Country

Czechia

Facility Name

Nemocnice Kyjov, p.o.

City

Kyjov

ZIP/Postal Code

69733

Country

Czechia

Facility Name

Plicni ambulance

City

Neratovice

ZIP/Postal Code

277 11

Country

Czechia

Facility Name

MephaCentrum, a s Plicni oddeleni

City

Ostrava - Poruba

ZIP/Postal Code

708 00

Country

Czechia

Facility Name

MephaCentrum, a.s.

City

Ostrava-Poruba

ZIP/Postal Code

708 00

Country

Czechia

Facility Name

PNEUMa-HOST s LO.

City

Praha

ZIP/Postal Code

158 00

Country

Czechia

Facility Name

PLiCNI AMBULANCE ROKYCANY, s.r o.

City

Rokycany

ZIP/Postal Code

337 01

Country

Czechia

Facility Name

Hrudnf ambulance s.r.o.

City

Zatec

ZIP/Postal Code

438 01

Country

Czechia

Facility Name

Dr. Kenessey Albert Korhaz-Rendetointezet, TOd6gy6gyaszati

City

Balassagyarmat

ZIP/Postal Code

H-2660

Country

Hungary

Facility Name

Csornai Margit Korhaz, TOd6gy6gyaszat

City

Csorna

ZIP/Postal Code

H-9300

Country

Hungary

Facility Name

Kenezy Gyula Korhaz es Rendelomtezet, Klinikai Farmakologiai

City

Debrecen

ZIP/Postal Code

H-4043

Country

Hungary

Facility Name

Veszprern Megyei Tudbgyogyintezet

City

Farkasgyepű

ZIP/Postal Code

H-8582

Country

Hungary

Facility Name

Somogy Megyei Kaposi M6r Oktat6 Korhaz, Tudoqondozo

City

Kaposvar

ZIP/Postal Code

H-7400

Country

Hungary

Facility Name

Lumniczer Sandor Korhaz as Rendelointezet, Tudoqondozo

City

Kapuvar

ZIP/Postal Code

H-9330

Country

Hungary

Facility Name

Selye Janos Korhaz es Rendelointezet, Tud6gy6gyaszati Szakrendeles

City

Komárom

ZIP/Postal Code

H-2900

Country

Hungary

Facility Name

Szakorvosi Rendelointezet Monor, Tudoqondozo

City

Monor

ZIP/Postal Code

H-2200

Country

Hungary

Facility Name

Revamed Eqeszsequqyi Szolqaltato Kft.

City

Nyiregyhaza

ZIP/Postal Code

H-4400

Country

Hungary

Facility Name

Si6fok Kornaz-Rendelointezet, Tudoqondozo

City

Siofok

ZIP/Postal Code

H-8600

Country

Hungary

Facility Name

Farmakontroll Egeszsegugyi Szolqaltato Bt

City

Szazhalombatta

ZIP/Postal Code

H-2440

Country

Hungary

Facility Name

Csonqrad Megyei Mellkasi Beteqseqek Szakkorhaza, Tudoqondozo lntezet

City

Szeged

ZIP/Postal Code

H-6722

Country

Hungary

Facility Name

Territorial SBI of Healthcare <Territorial Clinical Hospital>

City

Barnaul

ZIP/Postal Code

656024

Country

Russian Federation

Facility Name

FSBI Far Eastern Research Centre ofPhysiology and Pathology of Breathing of Siberian branch of RAMS

City

Blagoveshchensk

ZIP/Postal Code

675000

Country

Russian Federation

Facility Name

SBI of Healthcare Regional Clinical Hospital #4 City consultative department for pulmonological patientsr

City

Chelyabinsk

ZIP/Postal Code

454021

Country

Russian Federation

Facility Name

Municipal Autonomous Institution (City ClinicalHospital #14)

City

Ekaterinburg

ZIP/Postal Code

620039

Country

Russian Federation

Facility Name

Municipal Budget Institution of Healthcare (City Clinical Hospital #3 n.a. M.A. Podgorbunsky)

City

Kemerovo

ZIP/Postal Code

650000,

Country

Russian Federation

Facility Name

FSSI Scientific Research Institute of Complex Cardiovascular Pathology

City

Kemerovo

ZIP/Postal Code

650002

Country

Russian Federation

Facility Name

FSBI

City

Moscow

ZIP/Postal Code

115682

Country

Russian Federation

Facility Name

Non-State Private Institution of Healthcare <Scientific Clinical Center>

City

Moscow

ZIP/Postal Code

125315

Country

Russian Federation

Facility Name

SBI of Healthcare of Nizhny-Novgorod region

City

Nizhny-Novgorod

ZIP/Postal Code

603126

Country

Russian Federation

Facility Name

SB1 of Healthcare of Novosibirsk region <Novosibirsk State Regional Clinical Hospital>l

City

Novosibirsk

ZIP/Postal Code

630087

Country

Russian Federation

Facility Name

SBI of Healthcare of Novosibirsk region <Novosibirsk State Regional Clinical Hospital>

City

Novosibirsk

ZIP/Postal Code

630087

Country

Russian Federation

Facility Name

SBEI of HPE <North-West State Medical University n.a. LL Mechnikov>

City

Saint-Petersburg

ZIP/Postal Code

195067

Country

Russian Federation

Facility Name

Alliance Biomedical, Russian Group LLC

City

St. Petersburg

ZIP/Postal Code

194358

Country

Russian Federation

Facility Name

SBr of Helathcareof Yaraslavl region Clinical Hospital of Emervency care n.a.N.V. Solovyev

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

12. IPD Sharing Statement

Citations:

PubMed Identifier

28919143

Citation

Ferguson GT, Goodin T, Tosiello R, Wheeler A, Kerwin E. Long-term safety of glycopyrrolate/eFlow(R) CS in moderate-to-very-severe COPD: Results from the Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer (GOLDEN) 5 randomized study. Respir Med. 2017 Nov;132:251-260. doi: 10.1016/j.rmed.2017.08.020. Epub 2017 Aug 24.

Results Reference

result

PubMed Identifier

30584583

Citation

Ferguson GT, Kerwin EM, Donohue JF, Ganapathy V, Tosiello RL, Bollu VK, Rajagopalan K. Health-Related Quality of Life Improvements in Moderate to Very Severe Chronic Obstructive Pulmonary Disease Patients on Nebulized Glycopyrrolate: Evidence from the GOLDEN Studies. Chronic Obstr Pulm Dis. 2018 Jun 6;5(3):193-207. doi: 10.15326/jcopdf.5.3.2017.0178.

Results Reference

derived

Learn more about this trial

A Long-Term Safety Trial of Treatment With Nebulized SUN-101 in Patients With COPD

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