Efficacy and Safety Trial of 12 Weeks of Treatment With Nebulized SUN-101 in Patients With COPD
NCT ID: NCT02347761
Last Updated: 2018-03-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
653 participants
INTERVENTIONAL
2015-02-28
2015-11-30
Brief Summary
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Study to Determine the Amount of Glycopyrrolate Absorbed in the Lungs After Taking the Medicine With a eFlow Nebulizer and Seebri® Breezhaler® With and Without Activated Charcoal in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD).
NCT02512302
Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SUN-101 50 mcg BID eFlow (CS) nebulizer
SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 50 mcg BID eFlow (CS) nebulizer
SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer
SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer
SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
Placebo BID eFlow (CS) nebulizer
Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer
Placebo BID eFlow Closed System (CS) nebulizer
Placebo twice daily (BID) eFlow 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 Closed System (CS) nebulizer
SUN-101 25 mcg BID eFlow (CS) nebulizer
SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
Placebo BID eFlow Closed System (CS) nebulizer
Placebo twice daily (BID) eFlow Closed System (CS) nebulizer
Eligibility Criteria
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Inclusion Criteria
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
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 ongoing bladder outflow obstruction or history of catheterization for relief of bladder outflow obstruction within the previous 6 months.
10. History of narrow angle glaucoma
11. History of hypersensitivity or intolerance to aerosol medications
12. Recent documented history (within the previous 3 months) of substance abuse
13. Significant psychiatric disease that would likely result in the subject not being able to complete the study, in the opinion of the Investigator
14. Participation in another investigational drug study where drug was received within 30 days prior to Screening (Visit 1) or current participation in another investigational drug trial, including a SUN-101 study
15. Previously received SUN-101 (active treatment; formerly known as EP-101).
16. Contraindicated for treatment with, or having a history of reactions/hypersensitivity to anticholinergic agents, beta2 agonists, or sympathomimetic amines
40 Years
ALL
No
Sponsors
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Sunovion Respiratory Development Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Respiratory Medical Director, MD
Role: STUDY_DIRECTOR
Sunovion Respiratory Director
Locations
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Pinnacle Research Group, LLC
Anniston, Alabama, United States
Pulmonary Associates, PA
Phoenix, Arizona, United States
Clinical Research Consortium - Arizona
Tempe, Arizona, United States
Desert Sun Clinical Research, LLC
Tucson, Arizona, United States
Western States Clinical Research, Inc.
Wheat Ridge, Colorado, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States
Clermont Medical Research
Clermont, Florida, United States
Riverside Clinical Research
Edgewater, Florida, United States
Pulmonary Disease Specialists, PA, d/b/a PDS Research
Kissimmee, Florida, United States
AppleMed Research, Inc.
Miami, Florida, United States
Clinical Trials of Florida, LLC
Miami, Florida, United States
Florida Institute for Clinical Research, LLC
Orlando, Florida, United States
Emerald Coast Research Associates
Panama City, Florida, United States
Clinical Research of West Florida, Inc
Tampa, Florida, United States
Abraham Reasearch, PLLC
Fort Mitchell, Kentucky, United States
Pulmonary Research Institute of Southeast Michigan
Livonia, Michigan, United States
Minnesota Lung Center
Edina, Minnesota, United States
Minnesota Lung Center
Woodbury, Minnesota, United States
Midwest Chest Consultants, P.C.
Saint Charles, Missouri, United States
Clinical Research Consortium
Las Vegas, Nevada, United States
AAIR Research Center
Rochester, New York, United States
American Health Research, Inc.
Charlotte, North Carolina, United States
Hickory Research Center
Hickory, North Carolina, United States
North Carolina Clinical Research
Raleigh, North Carolina, United States
PMG Research of Wilmington
Wilmington, North Carolina, United States
Columbus Regional Research Institute
Columbus, Ohio, United States
Columbus Clinical Research, Inc
Columbus, Ohio, United States
Optimed Research, LTD
Columbus, Ohio, United States
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, United States
Research Protocol Management Specialists
Pittsburgh, Pennsylvania, United States
Safe Harbor Clinical Research
East Providence, Rhode Island, United States
Palmetto Medical Research Associates, LLC
Easley, South Carolina, United States
Greenville Pharmaceutical Research, Inc
Greenville, South Carolina, United States
Upstate Pharmaceutical Research
Greenville, South Carolina, United States
Piedmont Research Partners, LLC
Old Point Station, South Carolina, United States
S. Carolina Pharmaceutical Research
Spartanburg, South Carolina, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
CU Pharmaceutical Research
Union, South Carolina, United States
Texas Pulmonary and Critical Care Consultants, PA
Fort Worth, Texas, United States
Pioneer Research Solutions, Inc.
Houston, Texas, United States
Central Texas Health Research
New Braunfels, Texas, United States
Sylvana Research Associates
San Antonio, Texas, United States
Pulmonary Research of Abingdon, LLC
Abingdon, Virginia, United States
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia, United States
Countries
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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.
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.
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.
Other Identifiers
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SUN101-301
Identifier Type: -
Identifier Source: org_study_id
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