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CompletedNCT02276222GOLDEN-5Updated Mar 13, 2018Results posted

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

A Phase 3 interventional study of SUN-101 50 mcg BID eFlow (CS) nebulizer and Spiriva® 18 mcg QD Handihaler in Chronic Obstructive Pulmonary Disease (COPD), sponsored by Sunovion Respiratory Development Inc.. Completed at 118 sites in 4 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2018-03-13.

Sponsored by Sunovion Respiratory Development Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,087
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study 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).

Read the 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).

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease (COPD)

Keywords

  • Chronic Obstructive Pulmonary Disease
  • COPD
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 1,087 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Sunovion Respiratory Development Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female patients age ≥ 40 years, inclusive.
  2. A clinical diagnosis of COPD according to the GOLD 2014 guidelines.
  3. Current smokers or ex-smokers with at least 10 pack-year smoking history (eg, at least 1 pack/day for 10 years, or equivalent).
  4. Post-bronchodilator (following inhalation of ipratropium bromide) FEV1 \< 80% of predicted normal and > 0.7 L during Screening (Visit 1).
  5. Post-bronchodilator (following inhalation of ipratropium bromide) FEV1/FVC ratio \< 0.70 during Screening (Visit 1).
  6. Ability to perform reproducible spirometry according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines (2005).
  7. 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..
  8. Willing and able to provide written informed consent.
  9. Willing and able to attend all study visits and adhere to all study assessments and procedures.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Concomitant clinically significant respiratory disease other than COPD (eg, asthma, tuberculosis, bronchiectasis or other non-specific pulmonary disease).
  3. Recent history of COPD exacerbation requiring hospitalization or need for increased treatments for COPD within 6 weeks prior to Screening (Visit 1).
  4. Use of daily oxygen therapy > 12 hours per day.
  5. Respiratory tract infection within 6 weeks prior to Screening (Visit 1).
  6. Use of systemic steroids within 3 months prior to Screening (Visit 1).
  7. 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.
  8. Prolonged QTc (> 450 msec for males and > 470 msec for females) during Screening (Visit 1), or history of long QT syndrome.
  9. History of or clinically significant ongoing bladder outflow obstruction or history of catheterization for relief of bladder outflow obstruction within the previous 6 months.
  10. History of narrow angle glaucoma.
  11. History of hypersensitivity or intolerance to aerosol medications.
  12. Recent documented history (within the previous 3 months) of substance abuse.
  13. Significant psychiatric disease that would likely result in the subject not being able to complete the study, in the opinion of the Investigator.
  14. 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.
  15. Previously received SUN-101 (active treatment; formerly known as EP-101).
  16. Contraindicated for treatment with, or having a history of reactions/ hypersensitivity to anticholinergic agents, beta2 agonists, or sympathomimetic amines.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,087 participants (actual)

Study arms

  • Experimental
    SUN-101 50 mcg BID eFlow (CS) nebulizer

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

    Drug: SUN-101 50 mcg BID eFlow (CS) nebulizer

  • Active comparator
    Spiriva 18 mcg QD Handihaler

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

    Drug: Spiriva® 18 mcg QD Handihaler

Interventions

  • DrugSUN-101 50 mcg BID eFlow (CS) nebulizer

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

    Also known as: Glycopyrrolate

  • DrugSpiriva® 18 mcg QD Handihaler

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

    Also known as: (tiotropium)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to Week 48

  2. 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.

    Time frame: Up to Week 48

  3. 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.

    Time frame: Up to Week 48

  4. 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.

    Time frame: Up to Week 48

  5. 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.

    Time frame: Up to Week 48

  6. 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.

    Time frame: Up to 48 Weeks

Secondary outcomes

  1. 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.

    Time frame: Up to Week 48

  2. Percentage 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.

    Time frame: Up to 48 Weeks

  3. Incidence Rate Per 1000 Person Years 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.

    Time frame: up to week 48

  4. 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.

    Time frame: Up to Week 48

07

Results

Posted Mar 13, 2018

Participant flow

Participant flow — Overall Study
MilestoneSUN-101 50 mcg BID eFlow (CS) NebulizerSpiriva 18 mcg QD Handihaler
Started621466
Completed436402
Not completed18564
Withdrew: Adverse event6211
Withdrew: Death34
Withdrew: Lack of efficacy133
Withdrew: Protocol violation32
Withdrew: Withdrawal by subject7933
Withdrew: Non compliance with study medication62
Withdrew: Sponsor decision03
Withdrew: Lost to follow-up155
Withdrew: Physician decision21
Withdrew: Sheduling conflict10
Withdrew: Subject withdrew after randomization10

Outcome measures

PrimaryNumber 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.

Time frame:
Up to Week 48
Reported as:
Number · participants
Number of Subjects With Treatment-emergent Adverse Events (TEAE)
participantsSUN-101 50 mcg BID eFlow (CS) NebulizerSpiriva 18 mcg QD Handihaler
Number of Subjects With Treatment-emergent Adverse Events (TEAE)430312
PrimaryPercentage 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.

Time frame:
Up to Week 48
Reported as:
Number · percentage of participants
Percentage of Subjects With Treatment-emergent Adverse Events
percentage of participantsSUN-101 50 mcg BID eFlow (CS) NebulizerSpiriva 18 mcg QD Handihaler
Percentage of Subjects With Treatment-emergent Adverse Events69.467.0
PrimaryNumber 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.

Time frame:
Up to Week 48
Reported as:
Number · participants
Number of Subjects With Treatment-emergent Serious Adverse Events (SAE)
participantsSUN-101 50 mcg BID eFlow (CS) NebulizerSpiriva 18 mcg QD Handihaler
Number of Subjects With Treatment-emergent Serious Adverse Events (SAE)7649
PrimaryPercentage 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.

Time frame:
Up to Week 48
Reported as:
Number · percentage of participants
Percentage of Subjects With Treatment-emergent Serious Adverse
percentage of participantsSUN-101 50 mcg BID eFlow (CS) NebulizerSpiriva 18 mcg QD Handihaler
Percentage of Subjects With Treatment-emergent Serious Adverse12.310.5
PrimaryNumber 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.

Time frame:
Up to Week 48
Reported as:
Number · participants
Number of Subjects Who Discontinue the Study Due to TEAE
participantsSUN-101 50 mcg BID eFlow (CS) NebulizerSpiriva 18 mcg QD Handihaler
Number of Subjects Who Discontinue the Study Due to TEAE6213
PrimaryPercentage 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.

Time frame:
Up to 48 Weeks
Reported as:
Number · percentage of participants
Percentage of Subjects Who Discontinue the Study Due to TEAE
percentage of participantsSUN-101 50 mcg BID eFlow (CS) NebulizerSpiriva 18 mcg QD Handihaler
Percentage of Subjects Who Discontinue the Study Due to TEAE10.02.8
SecondaryNumber 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.

Time frame:
Up to Week 48
Reported as:
Number · participants
Number of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke
participantsSUN-101 50 mcg BID eFlow (CS) NebulizerSpiriva 18 mcg QD Handihaler
MACE score38
cardiovascular death12
non-fatal myocardial infarction25
non-fatal stroke01
SecondaryPercentage 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.

Time frame:
Up to 48 Weeks
Reported as:
Number · percentage of participants
Percentage of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke
percentage of participantsSUN-101 50 mcg BID eFlow (CS) NebulizerSpiriva 18 mcg QD Handihaler
MACE score0.51.7
cardiovascular death0.20.4
non-fatal myocardial infarction0.31.1
non-fatal stroke00.2
SecondaryIncidence Rate Per 1000 Person Years 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.

Time frame:
up to week 48
Reported as:
Number · event per 1000 person years
Incidence Rate Per 1000 Person Years of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke
event per 1000 person yearsSUN-101 50 mcg BID eFlow (CS) NebulizerSpiriva 18 mcg QD Handihaler
MACE score6.420.3
cardiovascular death2.15.1
non-fatal myocardial infarction4.312.7
non-fatal stroke02.5
SecondaryMean 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.

Time frame:
Up to Week 48
Reported as:
Least squares mean · liters
Mean Change From Baseline Over 48 Weeks in Trough FEV1 for All Subjects
litersSUN-101 50 mcg BID eFlow (CS) NebulizerSpiriva 18 mcg QD Handihaler
Mean Change From Baseline Over 48 Weeks in Trough FEV1 for All Subjects0.1016 ± 0.006980.0931 ± 0.00779
Statistical analysis
  • SUN-101 50 mcg BID eFlow (CS) Nebulizer vs Spiriva 18 mcg QD Handihaler · ANCOVA · p = 0.4041 · Least squares mean (se): 0.0084 · 95% CI -0.0114 to 0.0283

Adverse events

Collected over up to week 48. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SUN-101 50 mcg BID eFlow (CS) Nebulizer3/620 (0.5%)76/620 (12.3%)195/620 (31.5%)
Spiriva 18 mcg QD Handihaler4/466 (0.9%)49/466 (10.5%)133/466 (28.5%)
Most frequent serious events
Showing 10 of 99
Most frequent serious events
EventSUN-101 50 mcg BID eFlow (CS) NebulizerSpiriva 18 mcg QD Handihaler
chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders17/62014/466
pheumoniaInfections and infestations8/6203/466
sepsisInfections and infestations0/6203/466
cardio respiratory arrestCardiac disorders3/6201/466
coronary artery diseaseCardiac disorders3/6200/466
hip fractureInjury, poisoning and procedural complications3/6200/466
pneumothoraxRespiratory, thoracic and mediastinal disorders3/6200/466
cardiac failure congestiveCardiac disorders1/6202/466
non-cardiac chest painGeneral disorders1/6202/466
osteoarthritisMusculoskeletal and connective tissue disorders1/6202/466
Most frequent other events
Most frequent other events
EventSUN-101 50 mcg BID eFlow (CS) NebulizerSpiriva 18 mcg QD Handihaler
chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders91/62082/466
coughRespiratory, thoracic and mediastinal disorders73/62026/466
upper respiratory tract infectionInfections and infestations38/62025/466
nasopharyngitisInfections and infestations25/62028/466

Baseline characteristics

As noted in the participant flow section, one subject withdrew at randomization due to a pre-treatment event prior to being dosed bringing the population total to 1086 from 1087.

Age, Categorical
Age, Categorical(Participants)SUN-101 50 mcg BID eFlow (CS) NebulizerSpiriva 18 mcg QD HandihalerTotal
<=18 years000
Between 18 and 65 years330256586
>=65 years290210500
Age, Continuous
Age, Continuous(years)SUN-101 50 mcg BID eFlow (CS) NebulizerSpiriva 18 mcg QD HandihalerTotal
Mean63.3 ± 8.4663.3 ± 8.9763.3 ± 8.68
Sex: Female, Male
Sex: Female, Male(Participants)SUN-101 50 mcg BID eFlow (CS) NebulizerSpiriva 18 mcg QD HandihalerTotal
Female270206476
Male350260610
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)SUN-101 50 mcg BID eFlow (CS) NebulizerSpiriva 18 mcg QD HandihalerTotal
Hispanic or Latino9918
Not Hispanic or Latino6114571068
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)SUN-101 50 mcg BID eFlow (CS) NebulizerSpiriva 18 mcg QD HandihalerTotal
American Indian or Alaska Native224
Asian112
Native Hawaiian or Other Pacific Islander000
Black or African American352762
White5824361018
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)SUN-101 50 mcg BID eFlow (CS) NebulizerSpiriva 18 mcg QD HandihalerTotal
Russia252146
Czechia549
Hungary342054
United States556421977
cardiovascular risk (low/high) and categories for high cardiovascular risk
cardiovascular risk (low/high) and categories for high cardiovascular risk(Participants)SUN-101 50 mcg BID eFlow (CS) NebulizerSpiriva 18 mcg QD HandihalerTotal
low cardiovascular risk219169388
high cardiovascular risk401297698
ischemic heart disease6144105
cerebrovascular disease281846
periheral arterial disease392463
clinically significant arrhythmia221436
heart failure23932
hyertension362275637
background long-acting beta (2) agonist (LABA) use
background long-acting beta (2) agonist (LABA) use(Participants)SUN-101 50 mcg BID eFlow (CS) NebulizerSpiriva 18 mcg QD HandihalerTotal
background LABA use -yes267192459
background LABA use -no353274627

1 further baseline measures are reported on the registry.

08

Study locations

118 sites
  • 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
    Saint Louis, Missouri 63141, United States
  • Midwest Clinical Research LLC
    Saint Louis, Missouri 63141, United States
  • The Clinical Research Center
    Saint 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
    Mount 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.
    Praha, 158 00, Czechia
  • PLiCNI AMBULANCE ROKYCANY, s.r o.
    Rokycany, 337 01, Czechia
  • Hrudnf ambulance s.r.o.
    Zatec, 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
    Kaposvar, H-7400, Hungary
  • Lumniczer Sandor Korhaz as Rendelointezet, Tudoqondozo
    Kapuvar, H-9330, Hungary
  • Selye Janos Korhaz es Rendelointezet, Tud6gy6gyaszati Szakrendeles
    Komárom, H-2900, Hungary
  • Szakorvosi Rendelointezet Monor, Tudoqondozo
    Monor, H-2200, Hungary

Showing the first 100 of 118 sites across 4 countries.

09

References and documents

Publications

  • 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. PubMed 28919143 ↗
  • 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. PubMed 30584583 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02276222
Lead sponsor
Sunovion Respiratory Development Inc.
Responsible party
Sponsor
First posted
Oct 28, 2014
Start date
Oct 2014
Primary completion
Feb 2016
Completion
Feb 2016
Results posted
Mar 13, 2018
Last update
Mar 13, 2018

Study contacts

Respiratory Medical Director
study director · Sunovion Respiratory Development

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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