COPDPhase 3GOLDEN-4NCT02347774
Efficacy and Safety Trial of 12 Weeks of Treatment With Nebulized SUN-101 in Patients With COPD (GOLDEN-4)
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 and Chronic Obstructive Pulmonary Disease, run by Sunovion Respiratory Development Inc. at 45 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, Chronic Obstructive Pulmonary Disease
- 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
- 641 participants
- Where
- 45 sitesUnited States
- Study dates
- Feb 2015to Dec 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 on-going 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
45 sites in 1 country.
45 sites in 1 country
United States45 sites
SEC Lung, LLC
Andalusia, Alabama, 36420
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Innovative Clinical Research
Broomfield, Colorado, 80023
IMMUNOe International Research Centers
Centennial, Colorado, 80112
Lowcountry Lung and Critical Care, PA
Charleston, South Carolina, 29406
New Horizons Clinical Research
Cincinnati, Ohio, 45242
Remington-Davis, Inc
Columbus, Ohio, 43215
Sridhar Guduri, MD
Dublin, Ohio, 43016
Duluth Biomedical Research, LLC
Duluth, Georgia, 30096
Easley Clinical Research
Easley, South Carolina, 29640
Liliestol Research LLC
Fargo, North Dakota, 58103
Gaffney Pharmaceutical Research
Gaffney, South Carolina, 29340
Spectrum Medical Research, LLC
Gaffney, South Carolina, 29341
Clinical Research of Gastonia
Gastonia, North Carolina, 28054
Pulmonary Associates, PA
Glendale, Arizona, 85306
PharmQuest
Greensboro, North Carolina, 27408
Clinical Research of Lake Norman
Huntersville, North Carolina, 28078
Jasper Summit Research, LLC
Jasper, Alabama, 35501
New Phase Research & Development
Knoxville, Tennessee, 37919
Longmont Pulmonary and Critical Care
Longmont, Colorado, 80501
Delaware Valley Clinical Research
Marlton, New Jersey, 08053
LaPorte County Institute for Clinical Research
Michigan City, Indiana, 46360
Minnesota Lung Center
Minneapolis, Minnesota, 55407
Clinical Research of Charleston
Mt. Pleasant, South Carolina, 29464
George Stanley Walker, MD
New Orleans, Louisiana, 70115
Health Research of Hampton Roads, Inc.
Newport News, Virginia, 23606
IPS Research Company
Oklahoma City, Oklahoma, 73103
Ribo Research, LLC dba Peninsula Research Inc.
Ormond Beach, Florida, 32174
Phoenix Medical Research Institute, LLC
Peoria, Arizona, 85381
Progressive Medical Research
Port Orange, Florida, 32127
Allergy Associates Research Center
Portland, Oregon, 97202
PMG Research of Raleigh, LLC
Raleigh, North Carolina, 27609
Pulmonary Associates of Richmond, Inc
Richmond, Virginia, 23229
Southeast Regional Research Group
Rincon, Georgia, 31326
Asthma and Allergy Center of Chicago, SC
River Forest, Illinois, 60305
CU Pharmaceutical Research
Rock Hill, South Carolina, 29732
Center for Clinical Trials of Sacramento, Inc.
Sacramento, California, 95823
Institute of HealthCare Assessment, Inc
San Diego, California, 92120
Hope Clinical Research
Seneca, South Carolina, 29678
CAR.E. Clinical Research
St Louis, Missouri, 63141
The Clinical Research Center, LLC
St Louis, Missouri, 63141
Multicare Pulmonary Specialists
Tacoma, Washington, 98405
Clinical Research Consortium
Tempe, Arizona, 85283
Southeastern Research Center, LLC
Winston-Salem, North Carolina, 27103
Pulmonary Care Research Group, PA
Winter Park, Florida, 32789
About this study
Official title: A 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-4 (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.
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease
- Being tested
- SUN-101 50 mcg BID eFlow (CS) nebulizer, SUN-101 25 mcg BID eFlow (CS) nebulizer, Placebo eFlow (CS) nebulizer
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD
- 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 (R) Closed System (CS) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizerDrug
SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer
Placebo eFlow (CS) nebulizerDrug
Placebo BID eFlow (R) 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) via e-Flow (R) Closed System (CS) nebulizer Receives: Drug: SUN-101 50 mcg BID eFlow (CS) nebulizer |
| SUN-101 25 mcg BID e-Flow (CS) nebulizer | Experimental | SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer Receives: Drug: SUN-101 25 mcg BID eFlow (CS) nebulizer |
| Placebo BID Eflow (CS) nebulizer | Placebo comparator | Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer Receives: Drug: Placebo eFlow (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.
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).
Measured: baseline and Week 12
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) Week 12
On-treatment 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.
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: Week 12
Secondary outcomes (14)
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 (MAR).
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.
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 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
Percentage of Subjects With Treatment Emergent Adverse Events (TEAE)
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)
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
Percentage of Subjects With Treatment Emergent Serious Adverse Events (SAE)
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
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
Percentage of Subjects Who Discontinue Treatment Due to TEAE
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
Number of Subjects With Major Adverse Cardiac Events (MACE)
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 Adverse Cardiac Events (MACE)
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
Incidence Rate Per 1000 Person-years of Subjects With Major Adverse Cardiac Events (MACE)
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)
Incidence 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 completionDec 2015
- Study completionDec 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
- 641 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 Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02347774
- Sponsor's protocol ID
- SUN101-302
- Acronym
- GOLDEN-4
- Status last verified
- Feb 2018
- First submitted
- 21 Jan 2015
- Last updated
- 13 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 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 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-4 (Glycopyrrolate for Obstructive Lung Disease Via Electronic Nebulizer
- ClinicalTrials.gov ID
- NCT02347774
- Acronym / sponsor ID
- GOLDEN-4 / SUN101-302
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 641 participants (actual)
- Lead sponsor
- Sunovion Respiratory Development Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 Jan 2015 (estimated)
- Results
- Posted 13 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.
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) via e-Flow (R) Closed System (CS) nebulizer |
| SUN-101 25 mcg BID e-Flow (CS) nebulizer | Experimental | Drug: SUN-101 25 mcg BID eFlow (CS) nebulizerSUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer |
| Placebo BID Eflow (CS) nebulizer | Placebo comparator | Drug: Placebo eFlow (CS) nebulizerPlacebo (BID) via e-Flow (R) Closed System (CS) 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 (R) Closed System (CS) nebulizer | Drug | SUN-101 50 mcg BID eFlow (CS) nebulizer |
| SUN-101 25 mcg BID eFlow (CS) nebulizerSUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer | Drug | SUN-101 25 mcg BID e-Flow (CS) nebulizer |
| Placebo eFlow (CS) nebulizerPlacebo BID eFlow (R) 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. 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).
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) Week 12
Time frame: Week 12
On-treatment 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. 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).
14 secondary outcomes
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 Treatment Emergent Adverse Events (TEAE)
Time frame: Week 0-12
Percentage 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
Percentage 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
Percentage of Subjects Who Discontinue Treatment Due to TEAE
Time frame: Week 0-12
Number of Subjects With Major Adverse Cardiac Events (MACE)
Time frame: Week 0-12
Percentage of Subjects With Major Adverse Cardiac Events (MACE)
Time frame: Week 0-12
Incidence Rate Per 1000 Person-years of Subjects With Major Adverse Cardiac Events (MACE)
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 13 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 Development
45 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 and Chronic Obstructive Pulmonary Disease, run by Sunovion Respiratory Development Inc. at 45 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 13 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 45 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 13 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 NCT02347774, 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 13 Mar 2018.