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Efficacy and Safety Trial of 12 Weeks of Treatment With Nebulized SUN-101 in Patients With COPD (GOLDEN-4)

NCT ID: NCT02347774

Last Updated: 2018-03-13

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

641 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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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

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COPD Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SUN-101 50 mcg BID eFlow (CS) nebulizer

SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer

Group Type EXPERIMENTAL

SUN-101 50 mcg BID eFlow (CS) nebulizer

Intervention Type DRUG

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

SUN-101 25 mcg BID e-Flow (CS) nebulizer

SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer

Group Type EXPERIMENTAL

SUN-101 25 mcg BID eFlow (CS) nebulizer

Intervention Type DRUG

SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer

Placebo BID Eflow (CS) nebulizer

Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer

Group Type PLACEBO_COMPARATOR

Placebo eFlow (CS) nebulizer

Intervention Type DRUG

Placebo BID eFlow (R) Closed System (CS) nebulizer

Interventions

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SUN-101 50 mcg BID eFlow (CS) nebulizer

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

Intervention Type DRUG

SUN-101 25 mcg BID eFlow (CS) nebulizer

SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer

Intervention Type DRUG

Placebo eFlow (CS) nebulizer

Placebo BID eFlow (R) Closed System (CS) nebulizer

Intervention Type DRUG

Eligibility Criteria

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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, eg, 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

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 oral, intravenous, or intramuscular 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 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
9. 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
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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sunovion Respiratory Development Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Respiratory Medical Director, MD

Role: STUDY_DIRECTOR

Sunovion Respiratory Development

Locations

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SEC Lung, LLC

Andalusia, Alabama, United States

Site Status

Jasper Summit Research, LLC

Jasper, Alabama, United States

Site Status

Pulmonary Associates, PA

Glendale, Arizona, United States

Site Status

Phoenix Medical Research Institute, LLC

Peoria, Arizona, United States

Site Status

Clinical Research Consortium

Tempe, Arizona, United States

Site Status

Center for Clinical Trials of Sacramento, Inc.

Sacramento, California, United States

Site Status

Institute of HealthCare Assessment, Inc

San Diego, California, United States

Site Status

Innovative Clinical Research

Broomfield, Colorado, United States

Site Status

IMMUNOe International Research Centers

Centennial, Colorado, United States

Site Status

Longmont Pulmonary and Critical Care

Longmont, Colorado, United States

Site Status

Ribo Research, LLC dba Peninsula Research Inc.

Ormond Beach, Florida, United States

Site Status

Progressive Medical Research

Port Orange, Florida, United States

Site Status

Pulmonary Care Research Group, PA

Winter Park, Florida, United States

Site Status

Atlanta Center for Medical Research

Atlanta, Georgia, United States

Site Status

Duluth Biomedical Research, LLC

Duluth, Georgia, United States

Site Status

Southeast Regional Research Group

Rincon, Georgia, United States

Site Status

Asthma and Allergy Center of Chicago, SC

River Forest, Illinois, United States

Site Status

LaPorte County Institute for Clinical Research

Michigan City, Indiana, United States

Site Status

George Stanley Walker, MD

New Orleans, Louisiana, United States

Site Status

Minnesota Lung Center

Minneapolis, Minnesota, United States

Site Status

CAR.E. Clinical Research

St Louis, Missouri, United States

Site Status

The Clinical Research Center, LLC

St Louis, Missouri, United States

Site Status

Delaware Valley Clinical Research

Marlton, New Jersey, United States

Site Status

Clinical Research of Gastonia

Gastonia, North Carolina, United States

Site Status

PharmQuest

Greensboro, North Carolina, United States

Site Status

Clinical Research of Lake Norman

Huntersville, North Carolina, United States

Site Status

PMG Research of Raleigh, LLC

Raleigh, North Carolina, United States

Site Status

Southeastern Research Center, LLC

Winston-Salem, North Carolina, United States

Site Status

Liliestol Research LLC

Fargo, North Dakota, United States

Site Status

New Horizons Clinical Research

Cincinnati, Ohio, United States

Site Status

Remington-Davis, Inc

Columbus, Ohio, United States

Site Status

Sridhar Guduri, MD

Dublin, Ohio, United States

Site Status

IPS Research Company

Oklahoma City, Oklahoma, United States

Site Status

Allergy Associates Research Center

Portland, Oregon, United States

Site Status

Lowcountry Lung and Critical Care, PA

Charleston, South Carolina, United States

Site Status

Easley Clinical Research

Easley, South Carolina, United States

Site Status

Gaffney Pharmaceutical Research

Gaffney, South Carolina, United States

Site Status

Spectrum Medical Research, LLC

Gaffney, South Carolina, United States

Site Status

Clinical Research of Charleston

Mt. Pleasant, South Carolina, United States

Site Status

CU Pharmaceutical Research

Rock Hill, South Carolina, United States

Site Status

Hope Clinical Research

Seneca, South Carolina, United States

Site Status

New Phase Research & Development

Knoxville, Tennessee, United States

Site Status

Health Research of Hampton Roads, Inc.

Newport News, Virginia, United States

Site Status

Pulmonary Associates of Richmond, Inc

Richmond, Virginia, United States

Site Status

Multicare Pulmonary Specialists

Tacoma, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 28838685 (View on PubMed)

Ohar 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.

Reference Type DERIVED
PMID: 30587959 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30584583 (View on PubMed)

Other Identifiers

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SUN101-302

Identifier Type: -

Identifier Source: org_study_id

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