A Long-Term Safety Trial of Treatment With Nebulized SUN-101 in Patients With COPD
GOLDEN-5
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)
1 other identifier
interventional
1,087
4 countries
118
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2014
Shorter than P25 for phase_3
118 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 14, 2014
CompletedFirst Posted
Study publicly available on registry
October 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedResults Posted
Study results publicly available
March 13, 2018
CompletedMarch 13, 2018
February 1, 2018
1.3 years
October 14, 2014
January 2, 2018
February 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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.
Up to Week 48
Percentage of Subjects With Treatment-emergent Adverse Events
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.
Up to Week 48
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.
Up to Week 48
Percentage of Subjects With Treatment-emergent Serious Adverse
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.
Up to Week 48
Number of Subjects Who Discontinue the Study Due to 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.
Up to Week 48
Percentage of Subjects Who Discontinue the Study Due to 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.
Up to 48 Weeks
Secondary Outcomes (4)
Number of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke
Up to Week 48
Percentage of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke
Up to 48 Weeks
Incidence Rate Per 1000 Person Years of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke
up to week 48
Mean Change From Baseline Over 48 Weeks in Trough FEV1 for All Subjects
Up to Week 48
Study Arms (2)
SUN-101 50 mcg BID eFlow (CS) nebulizer
EXPERIMENTALSUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer
Spiriva 18 mcg QD Handihaler
ACTIVE COMPARATORSpiriva (tiotropium) 18 mcg once daily (QD) via Handihaler
Interventions
SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer
Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (118)
SEC Lung LLC
Andalusia, Alabama, 36420, United States
Achieve Clinical Research LLC
Birmingham, Alabama, 35216, United States
Jasper Summit Research LLC
Jasper, Alabama, 35501, United States
Clinical Research Advantage, Inc.lEast Valley Family Physicians, PLC
Chandler, Arizona, 85224, United States
Desert Sun Clinical Research LLC
Tucson, Arizona, 85710, United States
Allianz Research Institute, Inc.
Fountain Valley, California, 92708, United States
Research Center of Fresno, Inc.
Fresno, California, 93702, United States
California Research Medical Group, lnc.
Fullerton, California, 92835, United States
Southern California Institute For Respiratory Diseases, Inc.
Los Angeles, California, 90048, United States
Integrated Research Group, Inc
Riverside, California, 92506, United States
Institute of Healthcare Assessments Inc.
San Diego, California, 92120, United States
Waterbury Pulmonary Associates, LLC
Waterbury, Connecticut, 06708, United States
Tampa Bay Clinical Research Center
Brandon, Florida, 33511, United States
Clinical Research of West Florida
Clearwater, Florida, 33765, United States
Avail Clinical Research, llC
DeLand, Florida, 32720, United States
The Community Research of South Florida
Hialeah, Florida, 33016, United States
AppleMed Research, Inc
Miami, Florida, 33155, United States
Research Institute of South Florida, Inc
Miami, Florida, 33173, United States
Clinical Trials of Florida, LLC
Miami, Florida, 33186, United States
Florida Institute For Clinical Research, LLC
Orlando, Florida, 32825, United States
Ribo Research, LLC dba Peninsula Research, Inc.
Ormond Beach, Florida, 32174, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, 33603, United States
Clinical Research of West Florida
Tampa, Florida, 33603, United States
Vero Lung Center
Vero Beach, Florida, 32960, United States
Gwinnett Biomedical Research
Lawrenceville, Georgia, 30046, United States
H.C. Research LLC
Coeur d'Alene, Idaho, 83814, United States
Evanston Premier Healthcare Research LLC
Evanston, Illinois, 60201, United States
Asthma and Allergy Center of Chicago SC
River Forest, Illinois, 60305, United States
LaPorte County Institute For Clinical Research
Michigan City, Indiana, 46360, United States
Buynak Clinical Research, P.C.
Valparaiso, Indiana, 46383, United States
Abraham Research, PLLC
Fort Mitchell, Kentucky, 41017, United States
Kentucky Lung Clinics, PSC
Hazard, Kentucky, 41701, United States
Bendel Medical Research Center, LLC
Lafayette, Louisiana, 70508, United States
New Orleans Center for Clinical Research
New Orleans, Louisiana, 70119, United States
Howard County Center for Lung and Sleep Medicine, LLC
Columbia, Maryland, 21044, United States
Pulmonary and Critical Care Associates of Baltimore
Towson, Maryland, 21204, United States
Cadillac Clinical Research LLC
Cadillac, Michigan, 49601, United States
Pulmonary Research Institute of Southeast Michigan
Livonia, Michigan, 48152, United States
Minnesota Lung Center
Edina, Minnesota, 55435, United States
Clinical Research Institute, Inc.
Minneapolis, Minnesota, 55402, United States
Minnesota Lung Center
Minneapolis, Minnesota, 55407, United States
Minnesota Lung Center
Woodbury, Minnesota, 55125, United States
Midwest Chest Consultants PC
Saint Charles, Missouri, 63301, United States
CARE Clinical Research
St Louis, Missouri, 63141, United States
Midwest Clinical Research LLC
St Louis, Missouri, 63141, United States
The Clinical Research Center
St Louis, Missouri, 63141, United States
Somnos Laboratories, Inc d/b/a Somnos Clinical Research
Lincoln, Nebraska, 68510, United States
Clinical Research Advantage Inc
Las Vegas, Nevada, 89128, United States
Delaware Valley Clinical Research, LLC
Marlton, New Jersey, 08053, United States
Atlantic Research Center, LLC
Ocean City, New Jersey, 07712, United States
Pulmonary and Allergy Associates, PA
Summit, New Jersey, 07901, United States
ISA Clinical Research
Jamaica, New York, 11435, United States
American Health Research, Inc.
Charlotte, North Carolina, 28207, United States
ARSM Research
Huntersville, North Carolina, 28078, United States
Clinical Research of Lake Norman
Huntersville, North Carolina, 28078, United States
North Carolina Clinical Research
Raleigh, North Carolina, 27607, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401, United States
Southeastern Research Center
Winston-Salem, North Carolina, 27103, United States
Lillestol Research, LLC
Fargo, North Dakota, 58103, United States
IVA Researcb
Cincinnati, Ohio, 45245, United States
Remington Davis Inc
Columbus, Ohio, 43215, United States
IPS Research Company
Oklahoma City, Oklahoma, 73103, United States
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, 97504, United States
Sunstone Medical Research, L.LC
Medford, Oregon, 97504, United States
Allergy Associates Research Center
Portland, Oregon, 97202, United States
Lowcountry Lung and Critical Care, PA
Charleston, South Carolina, 29406, United States
Easley Clinical Research
Easley, South Carolina, 29640, United States
Palmetto Medical Research Associates
Easley, South Carolina, 29640, United States
Gaffney Pharmaceutical Research
Gaffney, South Carolina, 29340, United States
Spectrum Medical Research, LLC
Gaffney, South Carolina, 29341, United States
Greenville Pharmaceutical Research, Inc.
Greenville, South Carolina, 29615, United States
Upstate Pharmaceutical Research, Inc.
Greenville, South Carolina, 29615, United States
DeGarmo Institute of Medical Research
Greer, South Carolina, 29651, United States
Clinical Research of Charleston
Mt. Pleasant, South Carolina, 29464, United States
Hope Clinical Research
Seneca, South Carolina, 29678, United States
S. Carolina Pharmaceutical Research
Spartanburg, South Carolina, 29303, United States
Spartanburg Medical Research
Spartanburg, South Carolina, 29303, United States
CU Pharmaceutical Research
Union, South Carolina, 29379, United States
New Phase Clinical Research & Development
Knoxville, Tennessee, 37919, United States
Corsicana Medical Research, PLLC
Corsicana, Texas, 75110, United States
Pioneer Research Solutions, Inc
Houston, Texas, 77099, United States
Alamo Clinical Research Associates
San Antonio, Texas, 78212, United States
Pulmonary Consultants PLLC
Tacoma, Washington, 98405, United States
Medicentrum Beroun s.r o.
Beroun, 266 01, Czechia
MediTrial, s.r.o Internf a pneumoloqicka ambulance
Jindřichův Hradec, 377 01, Czechia
Nemocnice Kyjov, p.o.
Kyjov, 69733, Czechia
Plicni ambulance
Neratovice, 277 11, Czechia
MephaCentrum, a s Plicni oddeleni
Ostrava - Poruba, 708 00, Czechia
MephaCentrum, a.s.
Ostrava-Poruba, 708 00, Czechia
PNEUMa-HOST s LO.
Prague, 158 00, Czechia
PLiCNI AMBULANCE ROKYCANY, s.r o.
Rokycany, 337 01, Czechia
Hrudnf ambulance s.r.o.
Žatec, 438 01, Czechia
Dr. Kenessey Albert Korhaz-Rendetointezet, TOd6gy6gyaszati
Balassagyarmat, H-2660, Hungary
Csornai Margit Korhaz, TOd6gy6gyaszat
Csorna, H-9300, Hungary
Kenezy Gyula Korhaz es Rendelomtezet, Klinikai Farmakologiai
Debrecen, H-4043, Hungary
Veszprern Megyei Tudbgyogyintezet
Farkasgyepű, H-8582, Hungary
Somogy Megyei Kaposi M6r Oktat6 Korhaz, Tudoqondozo
Kaposvár, H-7400, Hungary
Lumniczer Sandor Korhaz as Rendelointezet, Tudoqondozo
Kapuvár, H-9330, Hungary
Selye Janos Korhaz es Rendelointezet, Tud6gy6gyaszati Szakrendeles
Komárom, H-2900, Hungary
Szakorvosi Rendelointezet Monor, Tudoqondozo
Monor, H-2200, Hungary
Revamed Eqeszsequqyi Szolqaltato Kft.
Nyíregyháza, H-4400, Hungary
Si6fok Kornaz-Rendelointezet, Tudoqondozo
Siófok, H-8600, Hungary
Farmakontroll Egeszsegugyi Szolqaltato Bt
Százhalombatta, H-2440, Hungary
Csonqrad Megyei Mellkasi Beteqseqek Szakkorhaza, Tudoqondozo lntezet
Szeged, H-6722, Hungary
Territorial SBI of Healthcare <Territorial Clinical Hospital>
Barnaul, 656024, Russia
FSBI Far Eastern Research Centre ofPhysiology and Pathology of Breathing of Siberian branch of RAMS
Blagoveshchensk, 675000, Russia
SBI of Healthcare Regional Clinical Hospital #4 City consultative department for pulmonological patientsr
Chelyabinsk, 454021, Russia
Municipal Budget Institution of Healthcare (City Clinical Hospital #3 n.a. M.A. Podgorbunsky)
Kemerovo, 650000,, Russia
FSSI Scientific Research Institute of Complex Cardiovascular Pathology
Kemerovo, 650002, Russia
FSBI
Moscow, 115682, Russia
Non-State Private Institution of Healthcare <Scientific Clinical Center>
Moscow, 125315, Russia
SBI of Healthcare of Nizhny-Novgorod region
Nizhny Novgorod, 603126, Russia
SB1 of Healthcare of Novosibirsk region <Novosibirsk State Regional Clinical Hospital>l
Novosibirsk, 630087, Russia
SBI of Healthcare of Novosibirsk region <Novosibirsk State Regional Clinical Hospital>
Novosibirsk, 630087, Russia
Alliance Biomedical, Russian Group LLC
Saint Petersburg, 194358, Russia
SBEI of HPE <North-West State Medical University n.a. LL Mechnikov>
Saint Petersburg, 195067, Russia
SBr of Helathcareof Yaraslavl region Clinical Hospital of Emervency care n.a.N.V. Solovyev
Yaroslavl, 150003, Russia
Municipal Autonomous Institution (City ClinicalHospital #14)
Yekaterinburg, 620039, Russia
Related Publications (2)
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.
PMID: 28919143RESULTFerguson 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.
PMID: 30584583DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Respiratory Medical Director
- Organization
- Sunovion Pharmaceuticals Inc.
Study Officials
- STUDY DIRECTOR
Respiratory Medical Director
Sunovion Respiratory Development
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2014
First Posted
October 28, 2014
Study Start
October 1, 2014
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
March 13, 2018
Results First Posted
March 13, 2018
Record last verified: 2018-02