COPDPhase 3GOLDEN-3NCT02347761
Efficacy and Safety Trial of 12 Weeks of Treatment With Nebulized SUN-101 in Patients With COPD
A Phase 3 study testing SUN-101 50 mcg BID eFlow (CS) nebulizer and SUN-101 25 mcg BID eFlow (CS) nebulizer in people with COPD, run by Sunovion Respiratory Development Inc. at 44 sites in United States.
Trial summary
This is a trial of 12 weeks of treatment with nebulized SUN-101 using an Investigational eFlow® Closed System (CS) nebulizer in subjects with chronic obstructive pulmonary disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD 2014) guidelines. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- SUN-101 50 mcg BID eFlow (CS) nebulizer and SUN-101 25 mcg BID eFlow (CS) nebulizer
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 653 participants
- Where
- 44 sitesUnited States
- Study dates
- Feb 2015to Nov 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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, eg, 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
Who cannot join
- 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 oral, intravenous, or intramuscular steroids within 3 months prior to Screening (Visit 1)
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- 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 QTcF (> 450 msec for males and > 470 msec for females) during Screening (Visit 1) as determined from the report provided by the central laboratory, 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
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
Pulmonary Research of Abingdon, LLC
Abingdon, Virginia, 24210
Pinnacle Research Group, LLC
Anniston, Alabama, 36207
American Health Research, Inc.
Charlotte, North Carolina, 28207
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765
Clermont Medical Research
Clermont, Florida, 34711
Columbus Regional Research Institute
Columbus, Ohio, 31904
Columbus Clinical Research, Inc
Columbus, Ohio, 43213
Optimed Research, LTD
Columbus, Ohio, 43235
Palmetto Medical Research Associates, LLC
Easley, South Carolina, 29640
Safe Harbor Clinical Research
East Providence, Rhode Island, 02914
Riverside Clinical Research
Edgewater, Florida, 32132
Minnesota Lung Center
Edina, Minnesota, 55435
Abraham Reasearch, PLLC
Fort Mitchell, Kentucky, 41017
Texas Pulmonary and Critical Care Consultants, PA
Fort Worth, Texas, 76104
Greenville Pharmaceutical Research, Inc
Greenville, South Carolina, 29615
Upstate Pharmaceutical Research
Greenville, South Carolina, 29615
Hickory Research Center
Hickory, North Carolina, 28602
Pioneer Research Solutions, Inc.
Houston, Texas, 77099
Pulmonary Disease Specialists, PA, d/b/a PDS Research
Kissimmee, Florida, 34741
Clinical Research Consortium
Las Vegas, Nevada, 89119
Pulmonary Research Institute of Southeast Michigan
Livonia, Michigan, 48152
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, 97504
AppleMed Research, Inc.
Miami, Florida, 33155
Clinical Trials of Florida, LLC
Miami, Florida, 33186
Central Texas Health Research
New Braunfels, Texas, 78130
Piedmont Research Partners, LLC
Old Point Station, South Carolina, 29707
Florida Institute for Clinical Research, LLC
Orlando, Florida, 32825
Emerald Coast Research Associates
Panama City, Florida, 32405
Pulmonary Associates, PA
Phoenix, Arizona, 85006
Research Protocol Management Specialists
Pittsburgh, Pennsylvania, 15243
North Carolina Clinical Research
Raleigh, North Carolina, 27607
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia, 23225
AAIR Research Center
Rochester, New York, 14618
Midwest Chest Consultants, P.C.
Saint Charles, Missouri, 63301
Sylvana Research Associates
San Antonio, Texas, 78229
S. Carolina Pharmaceutical Research
Spartanburg, South Carolina, 29303
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
Clinical Research of West Florida, Inc
Tampa, Florida, 33603
Clinical Research Consortium - Arizona
Tempe, Arizona, 85283
Desert Sun Clinical Research, LLC
Tucson, Arizona, 85710
CU Pharmaceutical Research
Union, South Carolina, 29379
Western States Clinical Research, Inc.
Wheat Ridge, Colorado, 80033
PMG Research of Wilmington
Wilmington, North Carolina, 28401
Minnesota Lung Center
Woodbury, Minnesota, 55125
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Trial of 12 Weeks of Treatment With Nebulized SUN-101 in Patients With COPD: GOLDEN-3 (Glycopyrrolate for Obstructive Lung Disease Via Electronic Nebulizer)
This is a trial of 12 weeks of treatment with nebulized SUN-101 using an Investigational eFlow® Closed System (CS) nebulizer in subjects with chronic obstructive pulmonary disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD 2014) guidelines.
Read the detailed description
This is a Phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter, efficacy and safety trial of 12 weeks of treatment with nebulized SUN-101 using an Investigational eFlow® Closed System (CS) nebulizer in approximately 645 subjects with chronic obstructive pulmonary disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD 2014) guidelines.
SUN-101 or placebo will be administered twice daily as an oral inhalation using the investigational eFlow CS nebulizer. Approximately 150 subjects will be enrolled in the substudy (at selected sites only). These subjects will be required to participate in serial spirometry, vital signs, ECGs, and an additional Holter monitor assessment at Visit 6 (Week 12). This subset of subjects will be referred to as the Substudy Population.
- Conditions
- COPD
- Being tested
- SUN-101 50 mcg BID eFlow (CS) nebulizer, SUN-101 25 mcg BID eFlow (CS) nebulizer, Placebo BID eFlow Closed System (CS) nebulizer
- Keywords
- Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUN-101 50 mcg BID eFlow (CS) nebulizerDrug
SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizerDrug
SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
Placebo BID eFlow Closed System (CS) nebulizerDrug
Placebo twice daily (BID) eFlow Closed System (CS) nebulizer
| Study group | Role | What they receive |
|---|---|---|
| SUN-101 50 mcg BID eFlow (CS) nebulizer | Experimental | SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer Receives: Drug: SUN-101 50 mcg BID eFlow (CS) nebulizer |
| SUN-101 25 mcg BID eFlow (CS) nebulizer | Experimental | SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer Receives: Drug: SUN-101 25 mcg BID eFlow (CS) nebulizer |
| Placebo BID eFlow (CS) nebulizer | Placebo comparator | Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer Receives: Drug: Placebo BID eFlow Closed System (CS) nebulizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12
ALL COLLECTED-Spirometry was performed according to internationally accepted standards.Trough FEV1 at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose.Change from baseline in trough FEV1 was calculated as the trough FEV1 value at Week 12 minus the morning trough FEV1 at baseline (mean of the two pre-dose values at 45 and 15 minutes prior to the first dose). All collected values were used in this analyses, regardless if the subject remained on randomized treatment or not, and regardless if the values might potentially be affected by other therapies or not Values not collected remained as missing values and were assumed to be missing at random (MAR) "ALL COLLECTED" and "ON TREATMENT" data are the same. The only difference is in the number of visits included for those participants who may have discontinued randomized treatment but remained in the study." for all endpoints
Measured: Baseline and Week 12
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) Week 12
ON TEATMENT-Spirometry was performed according to internationally accepted standards.Trough FEV1 at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose.Change from baseline in trough FEV1 was calculated as the trough FEV1 value at Week 12 minus the morning trough FEV1 at baseline (mean of the two pre-dose values at 45 and 15 minutes prior to the first dose).Only on-treatment values (which included only data collected while subjects were taking study drug) are used for this analysis. Values affected by other medication use were set to missing. Non-collected or missing data were not imputed for this analysis. Values not collected remained as missing values and were assumed to be missing at random (MAR).
Measured: Baseline and Week 12
Secondary outcomes (16)
Standardized Change From Baseline at Week 12 in FEV1 Area Under the Curve (AUC) (0-12) in the Substudy Population
ALL COLLECTED The standardized FEV1 AUC(0-12) was calculated at weeks 0 and 12 for the Substudy Population with extended spirometry measurements. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time. Intermittent missing spirometry measurements were ignored and the trapezoidal rule would simply span the missing time point(s). If the Hour 12 time point was missing, then the AUC(0-12) calculation was based on the time interval up to the last non-missing time point prior to Hour 12. If a subject has a missing baseline FEV1, then that subject had a missing AUC. All collected values were used in the analyses, regardless if the subject remained on randomized treatment or not, and regardless if the values might potentially be affected by other therapies or not Values not collected remained as missing values and were assumed to be missing at random (MAR).
Measured: Baseline and Week 12
Standardized Change From Baseline at Week 12 in FEV1 Area Under the Curve (AUC) (0-12) in Substudy Population
ON TREATMENT The standardized FEV1 AUC(0-12) was calculated at weeks 0 and 12 for the Substudy Population with extended spirometry measurements. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time. Intermittent missing spirometry measurements were ignored and the trapezoidal rule would simply span the missing time points. If the Hour 12 time point was missing, then the AUC(0-12) calculation was based on the time interval up to the last non-missing time point prior to Hour 12. If a subject has a missing baseline FEV1, then that subject had a missing AUC.Only on-treatment values (which included only data collected while subjects were taking study drug) are used for this analysis. Values affected by other medication use were set to missing. Non-collected or missing data were not imputed for this analysis. Values not collected remained as missing values and were assumed to be missing at random (MAR).
Measured: Baseline and Week 12
Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 12
ALL COLLECTED Spirometry was performed according to internationally accepted standards. Trough FVC at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose.
All collected values were used in the analyses, regardless if the subject remained on randomized treatment or not, and regardless if the values might potentially be affected by other therapies or not Values not collected remained as missing values and were assumed to be missing at random
Measured: Baseline and Week 12
Change From Baseline in Trough Forced Vital Capacity (FVC) Week 12
ON TREATMENT Spirometry was performed according to internationally accepted standards. Trough FVC at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose. Change from baseline in trough FVC was calculated as the trough FVC value at Week 12 minus the morning trough FVC at baseline (mean of the two pre-dose values at 45 and 15 minutes prior to the first dose).Only on-treatment values (which included only data collected while subjects were taking study drug) are used for this analysis. Values affected by other medication use were set to missing. Non-collected or missing data were not imputed for this analysis. Values not collected remained as missing values and were assumed to be missing at random (MAR).
Measured: Baseline and Week 12
Change From Baseline in Health Status Measured by St. George's Respiratory Questionnaire (SGRQ) at Week 12/End of Study
ALL COLLECTED Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: symptoms, activity, and impacts. A score was calculated for each of these 3 subscales and a "Total" score was calculated. In each case the lowest possible value is 0 and the highest 100. Higher values correspond to greater impairment of health status.
All collected values were used in the analyses, regardless if the subject remained on randomized treatment or not. Values not collected remained as missing values and were assumed to be missing at random (MAR).
Measured: Baseline and Week 12
Change From Baseline in Health Status Measured by St. George's Respiratory Questionnaire (SGRQ) Week 12/End of Study
ON TREATMENT Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: symptoms, activity, and impacts. A score was calculated for each of these 3 subscales and a "Total" score was calculated. In each case the lowest possible value is 0 and the highest 100. Higher values correspond to greater impairment of health status.
Only on-treatment values (which included only data collected while subjects were taking study drug) are used for this analysis. Values affected by other medication use were set to missing. Non-collected or missing data were not imputed for this analysis. Values not collected remained as missing values and were assumed to be missing at random (MAR).
Measured: Baseline and Week 12
Change in Number of Rescue Medication Puffs Per Day Over the 12-week Double-blind Treatment Period
ALL COLLECTED Participants completed an electronic diary (eDiary) daily (night time) to record the number of puffs of rescue medication inhaled in the previous 24 hours. A negative change from baseline indicates improvement.
All collected values were used in the analyses, regardless if the subject remained on randomized treatment or not. Values not collected remained as missing values and were assumed to be missing at random (MAR).
Measured: Week 0-12
Number of Subjects With Major Adverse Cardiac Events (MACE)
ALL COLLECTED 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 for the double-blind period (from the first date of study medication until the date of last contact)
Measured: Week 0-12
Percentage of Subjects With Major Cardiac Events (MACE)
ALL COLLECTED 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 for the double-blind period (from the first date of study medication until the date of last contact)
Measured: Week 0-12
Number of Subjects With Treatment Emergent Adverse Events (TEAE)
ON TREATMENT A TEAE is defined as any non-serious AE that occurred on or after the first dose of study medication and within 7 days after the last dose of study medication, or any serious AE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent AE is an on-treatment AE.
Measured: Week 0-12
Percent of Subjects With Treatment Emergent Adverse Events (TEAE)
ON TREATMENT A TEAE is defined as any non-serious AE that occurred on or after the first dose of study medication and within 7 days after the last dose of study medication, or any serious AE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent AE is an on-treatment AE.
Measured: Week 0-12
Number of Subjects With Treatment Emergent Serious Adverse Events (SAE)
ON TREATMENT A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE
Measured: Week 0-12
Percent of Subjects With Treatment Emergent Serious Adverse Events (SAE)
ON TREATMENT A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE
Measured: Week 0-12
Number of Subjects Who Discontinue Treatment Due to TEAE
ON TREATMENT A TEAE is defined as any AE that occurred on or after the first dose of study medication and within 7 days after the last dose of study medication, or any serious AE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent AE is an on-treatment AE.
Measured: Week 0-12
Percent of Subjects Who Discontinue Treatment Due to TEAE
ON TREATMENT A TEAE is defined as any AE that occurred on or after the first dose of study medication and within 7 days after the last dose of study medication, or any serious AE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent AE is an on-treatment AE.
Measured: Week 0-12
Incidence Rate Per 100 Person-years of Subjects With Treatment Emergent Adverse Events (TEAE)
ALL COLLECTED 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 for the double-blind period (from the first date of study medication until the date of last contact)I ncidence rate: TT= Total Time in years. Total Time (TT) is defined as the time from the first date of study drug until the latter of the date of last contact or 30 days after the date of last dose. Incidence Rate (per 1000 person-years) = n/TT x 1000.
Measured: Week 0-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 653 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunovion Respiratory Development Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Respiratory Medical Director, MD, Study director, Sunovion Respiratory Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02347761
- Sponsor's protocol ID
- SUN101-301
- Acronym
- GOLDEN-3
- Status last verified
- Feb 2018
- First submitted
- 21 Jan 2015
- Last updated
- 22 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kerwin E, Donohue JF, Goodin T, Tosiello R, Wheeler A, Ferguson GT. Efficacy and safety of glycopyrrolate/eFlow(R) CS (nebulized glycopyrrolate) in moderate-to-very-severe COPD: Results from the glycopyrrolate for obstructive lung disease via electronic nebulizer (GOLDEN) 3 and 4 randomized controlled trials. Respir Med. 2017 Nov;132:238-250. doi: 10.1016/j.rmed.2017.07.011. Epub 2017 Jul 19.
PubMed 28838685Ohar J, Tosiello R, Goodin T, Sanjar S. Efficacy and safety of a novel, nebulized glycopyrrolate for the treatment of COPD: effect of baseline disease severity and age; pooled analysis of GOLDEN 3 and GOLDEN 4. Int J Chron Obstruct Pulmon Dis. 2018 Dec 18;14:27-37. doi: 10.2147/COPD.S184808. eCollection 2019.
PubMed 30587959Ferguson 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Trial of 12 Weeks of Treatment With Nebulized SUN-101 in Patients With COPD: GOLDEN-3 (Glycopyrrolate for Obstructive Lung Disease Via Electronic Nebulizer)
- ClinicalTrials.gov ID
- NCT02347761
- Acronym / sponsor ID
- GOLDEN-3 / SUN101-301
- Conditions
- COPD
- Keywords
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 653 participants (actual)
- Lead sponsor
- Sunovion Respiratory Development Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 27 Jan 2015 (estimated)
- Results
- Posted 22 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a trial of 12 weeks of treatment with nebulized SUN-101 using an Investigational eFlow® Closed System (CS) nebulizer in subjects with chronic obstructive pulmonary disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD 2014) guidelines.
Detailed description
This is a Phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter, efficacy and safety trial of 12 weeks of treatment with nebulized SUN-101 using an Investigational eFlow® Closed System (CS) nebulizer in approximately 645 subjects with chronic obstructive pulmonary disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD 2014) guidelines.
SUN-101 or placebo will be administered twice daily as an oral inhalation using the investigational eFlow CS nebulizer. Approximately 150 subjects will be enrolled in the substudy (at selected sites only). These subjects will be required to participate in serial spirometry, vital signs, ECGs, and an additional Holter monitor assessment at Visit 6 (Week 12). This subset of subjects will be referred to as the Substudy Population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SUN-101 50 mcg BID eFlow (CS) nebulizer | Experimental | Drug: SUN-101 50 mcg BID eFlow (CS) nebulizerSUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer |
| SUN-101 25 mcg BID eFlow (CS) nebulizer | Experimental | Drug: SUN-101 25 mcg BID eFlow (CS) nebulizerSUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer |
| Placebo BID eFlow (CS) nebulizer | Placebo comparator | Drug: Placebo BID eFlow Closed System (CS) nebulizerPlacebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SUN-101 50 mcg BID eFlow (CS) nebulizerSUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer | Drug | SUN-101 50 mcg BID eFlow (CS) nebulizer |
| SUN-101 25 mcg BID eFlow (CS) nebulizerSUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer | Drug | SUN-101 25 mcg BID eFlow (CS) nebulizer |
| Placebo BID eFlow Closed System (CS) nebulizerPlacebo twice daily (BID) eFlow Closed System (CS) nebulizer | Drug | Placebo BID eFlow (CS) nebulizer |
Primary outcome
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12
Time frame: Baseline and Week 12
ALL COLLECTED-Spirometry was performed according to internationally accepted standards.Trough FEV1 at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose.Change from baseline in trough FEV1 was calculated as the trough FEV1 value at Week 12 minus the morning trough FEV1 at baseline (mean of the two pre-dose values at 45 and 15 minutes prior to the first dose). All collected values were used in this analyses, regardless if the subject remained on randomized treatment or not, and regardless if the values might potentially be affected by other therapies or not Values not collected remained as missing values and were assumed to be missing at random (MAR) "ALL COLLECTED" and "ON TREATMENT" data are the same. The only difference is in the number of visits included for those participants who may have discontinued randomized treatment but remained in the study." for all endpoints
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) Week 12
Time frame: Baseline and Week 12
ON TEATMENT-Spirometry was performed according to internationally accepted standards.Trough FEV1 at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose.Change from baseline in trough FEV1 was calculated as the trough FEV1 value at Week 12 minus the morning trough FEV1 at baseline (mean of the two pre-dose values at 45 and 15 minutes prior to the first dose).Only on-treatment values (which included only data collected while subjects were taking study drug) are used for this analysis. Values affected by other medication use were set to missing. Non-collected or missing data were not imputed for this analysis. Values not collected remained as missing values and were assumed to be missing at random (MAR).
16 secondary outcomes
Standardized Change From Baseline at Week 12 in FEV1 Area Under the Curve (AUC) (0-12) in the Substudy Population
Time frame: Baseline and Week 12
Standardized Change From Baseline at Week 12 in FEV1 Area Under the Curve (AUC) (0-12) in Substudy Population
Time frame: Baseline and Week 12
Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Trough Forced Vital Capacity (FVC) Week 12
Time frame: Baseline and Week 12
Change From Baseline in Health Status Measured by St. George's Respiratory Questionnaire (SGRQ) at Week 12/End of Study
Time frame: Baseline and Week 12
Change From Baseline in Health Status Measured by St. George's Respiratory Questionnaire (SGRQ) Week 12/End of Study
Time frame: Baseline and Week 12
Change in Number of Rescue Medication Puffs Per Day Over the 12-week Double-blind Treatment Period
Time frame: Week 0-12
Number of Subjects With Major Adverse Cardiac Events (MACE)
Time frame: Week 0-12
Percentage of Subjects With Major Cardiac Events (MACE)
Time frame: Week 0-12
Number of Subjects With Treatment Emergent Adverse Events (TEAE)
Time frame: Week 0-12
Percent of Subjects With Treatment Emergent Adverse Events (TEAE)
Time frame: Week 0-12
Number of Subjects With Treatment Emergent Serious Adverse Events (SAE)
Time frame: Week 0-12
Percent of Subjects With Treatment Emergent Serious Adverse Events (SAE)
Time frame: Week 0-12
Number of Subjects Who Discontinue Treatment Due to TEAE
Time frame: Week 0-12
Percent of Subjects Who Discontinue Treatment Due to TEAE
Time frame: Week 0-12
Incidence Rate Per 100 Person-years of Subjects With Treatment Emergent Adverse Events (TEAE)
Time frame: Week 0-12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28838685Kerwin E, Donohue JF, Goodin T, Tosiello R, Wheeler A, Ferguson GT. Efficacy and safety of glycopyrrolate/eFlow(R) CS (nebulized glycopyrrolate) in moderate-to-very-severe COPD: Results from the glycopyrrolate for obstructive lung disease via electronic nebulizer (GOLDEN) 3 and 4 randomized controlled trials. Respir Med. 2017 Nov;132:238-250. doi: 10.1016/j.rmed.2017.07.011. Epub 2017 Jul 19.
- Derived from this study: PubMed 30587959Ohar J, Tosiello R, Goodin T, Sanjar S. Efficacy and safety of a novel, nebulized glycopyrrolate for the treatment of COPD: effect of baseline disease severity and age; pooled analysis of GOLDEN 3 and GOLDEN 4. Int J Chron Obstruct Pulmon Dis. 2018 Dec 18;14:27-37. doi: 10.2147/COPD.S184808. eCollection 2019.
- Derived from this study: PubMed 30584583Ferguson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Respiratory Medical Director, MD study director
Sunovion Respiratory Director
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SUN-101 50 mcg BID eFlow (CS) nebulizer and SUN-101 25 mcg BID eFlow (CS) nebulizer in people with COPD, run by Sunovion Respiratory Development Inc. at 44 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (time frame: Baseline and Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02347761, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2018.