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

NCT02347774 | Completed Phase 3 Results

• 1 other identifier: SUN101-302
• Study Type: interventional
• Target: 641
• Locations: 1 country
• Sites: 45

Brief 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.

Conditions

COPD; Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease; COPD

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  Week 12

Secondary Outcomes (14)

• Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 12

  baseline and Week 12

• Change From Baseline in Trough Forced Vital Capacity (FVC)Week 12

  baseline and Week 12

• Change From Baseline in Health Status Measured by St. George's Respiratory Questionnaire (SGRQ) at Week 12/End of Study

  baseline and Week 12

• Change From Baseline in Health Status Measured by St. George's Respiratory Questionnaire (SGRQ) Week 12/End of Study

  baseline and Week 12

• Change in Number of Rescue Medication Puffs Per Day Over the 12-week Double-blind Treatment Period

  Week 0-12

Study Arms (3)

SUN-101 50 mcg BID eFlow (CS) nebulizer

EXPERIMENTAL

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

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

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

Drug: Placebo eFlow (CS) nebulizer

Interventions

SUN-101 50 mcg BID eFlow (CS) nebulizer DRUG

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

SUN-101 50 mcg BID eFlow (CS) nebulizer

SUN-101 25 mcg BID eFlow (CS) nebulizer DRUG

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

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

Placebo eFlow (CS) nebulizer DRUG

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

Placebo BID Eflow (CS) nebulizer

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients age ≥ 40 years, inclusive
• A clinical diagnosis of COPD according to the GOLD 2014 guidelines
• Current smokers or ex-smokers with at least 10 pack-year smoking history (eg, at least 1 pack/day for 10 years, or equivalent)
• Post-bronchodilator (following inhalation of ipratropium bromide) FEV1 \< 80% of predicted normal and \> 0.7 L during Screening (Visit 1)
• Post-bronchodilator (following inhalation of ipratropium bromide) FEV1/FVC ratio \< 0.70 during Screening (Visit 1)
• Ability to perform reproducible spirometry according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines (2005)
• Subject, if female ≤ 65 years of age and of child bearing potential, must have a negative serum pregnancy test at Visit 1. Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control: a) an oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study with continued use throughout the study and for thirty days following participation; b) barrier method of contraception, 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

You may not qualify if:

• Severe comorbidities including unstable cardiac or pulmonary disease or any other medical conditions that would, in the opinion of the Investigator, preclude the subject from safely completing the required tests or the study, or is likely to result in disease progression that would require withdrawal of the subject
• Concomitant clinically significant respiratory disease other than COPD (eg, asthma, tuberculosis, bronchiectasis or other non-specific pulmonary disease).
• Recent history of COPD exacerbation requiring hospitalization or need for increased treatments for COPD within 6 weeks prior to Screening (Visit 1).
• Use of daily oxygen therapy \> 12 hours per day
• Respiratory tract infection within 6 weeks prior to Screening (Visit 1)
• Use of oral, intravenous, or intramuscular steroids within 3 months prior to Screening (Visit 1)
• History of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localized basal cell carcinoma of the skin
• Prolonged 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)

Sponsors & Collaborators

• Sunovion Respiratory Development Inc.: lead

Study Sites (45)

SEC Lung, LLC

Andalusia, Alabama, 36420, United States

Location

Jasper Summit Research, LLC

Jasper, Alabama, 35501, United States

Location

Pulmonary Associates, PA

Glendale, Arizona, 85306, United States

Location

Phoenix Medical Research Institute, LLC

Peoria, Arizona, 85381, United States

Location

Clinical Research Consortium

Tempe, Arizona, 85283, United States

Location

Center for Clinical Trials of Sacramento, Inc.

Sacramento, California, 95823, United States

Location

Institute of HealthCare Assessment, Inc

San Diego, California, 92120, United States

Location

Innovative Clinical Research

Broomfield, Colorado, 80023, United States

Location

IMMUNOe International Research Centers

Centennial, Colorado, 80112, United States

Location

Longmont Pulmonary and Critical Care

Longmont, Colorado, 80501, United States

Location

Ribo Research, LLC dba Peninsula Research Inc.

Ormond Beach, Florida, 32174, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Pulmonary Care Research Group, PA

Winter Park, Florida, 32789, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

Duluth Biomedical Research, LLC

Duluth, Georgia, 30096, United States

Location

Southeast Regional Research Group

Rincon, Georgia, 31326, United States

Location

Asthma and Allergy Center of Chicago, SC

River Forest, Illinois, 60305, United States

Location

LaPorte County Institute for Clinical Research

Michigan City, Indiana, 46360, United States

Location

George Stanley Walker, MD

New Orleans, Louisiana, 70115, United States

Location

Minnesota Lung Center

Minneapolis, Minnesota, 55407, United States

Location

CAR.E. Clinical Research

St Louis, Missouri, 63141, United States

Location

The Clinical Research Center, LLC

St Louis, Missouri, 63141, United States

Location

Delaware Valley Clinical Research

Marlton, New Jersey, 08053, United States

Location

Clinical Research of Gastonia

Gastonia, North Carolina, 28054, United States

Location

PharmQuest

Greensboro, North Carolina, 27408, United States

Location

Clinical Research of Lake Norman

Huntersville, North Carolina, 28078, United States

Location

PMG Research of Raleigh, LLC

Raleigh, North Carolina, 27609, United States

Location

Southeastern Research Center, LLC

Winston-Salem, North Carolina, 27103, United States

Location

Liliestol Research LLC

Fargo, North Dakota, 58103, United States

Location

New Horizons Clinical Research

Cincinnati, Ohio, 45242, United States

Location

Remington-Davis, Inc

Columbus, Ohio, 43215, United States

Location

Sridhar Guduri, MD

Dublin, Ohio, 43016, United States

Location

IPS Research Company

Oklahoma City, Oklahoma, 73103, United States

Location

Allergy Associates Research Center

Portland, Oregon, 97202, United States

Location

Lowcountry Lung and Critical Care, PA

Charleston, South Carolina, 29406, United States

Location

Easley Clinical Research

Easley, South Carolina, 29640, United States

Location

Gaffney Pharmaceutical Research

Gaffney, South Carolina, 29340, United States

Location

Spectrum Medical Research, LLC

Gaffney, South Carolina, 29341, United States

Location

Clinical Research of Charleston

Mt. Pleasant, South Carolina, 29464, United States

Location

CU Pharmaceutical Research

Rock Hill, South Carolina, 29732, United States

Location

Hope Clinical Research

Seneca, South Carolina, 29678, United States

Location

New Phase Research & Development

Knoxville, Tennessee, 37919, United States

Location

Health Research of Hampton Roads, Inc.

Newport News, Virginia, 23606, United States

Location

Pulmonary Associates of Richmond, Inc

Richmond, Virginia, 23229, United States

Location

Multicare Pulmonary Specialists

Tacoma, Washington, 98405, United States

Location

Related Publications (3)

• 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.

  PMID: 28838685 RESULT

• 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.

  PMID: 30587959 DERIVED

• 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.

  PMID: 30584583 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Nebulizers and Vaporizers

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Results Point of Contact

• Title: Respiratory Medical Director
• Organization: Sunovion Pharmaceuticals Inc.

1-866-503-6351

Study Officials

• Respiratory Medical Director, MD

  Sunovion Respiratory Development

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2015
• First Posted: January 27, 2015
• Study Start: February 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 13, 2018
• Results First Posted: March 13, 2018

Record last verified: 2018-02

Locations

US (45)