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

Completed · Phase 3 · Has a placebo group

Conditions studied: COPD, Chronic Obstructive Pulmonary Disease

In brief

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.

Key facts

Study ID

NCT02347774

Run by

Sunovion Respiratory Development Inc.

People needed

641

Starts

2015-02-01

Expected to finish

2015-12-01

Last updated by the study team

2018-03-13

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

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)
• Contraindicated for treatment with, or having a history of reactions/hypersensitivity to anticholinergic agents, beta2 agonists, or sympathomimetic amines

Where it is running

• SEC Lung, LLC — Andalusia, Alabama, United States
• Jasper Summit Research, LLC — Jasper, Alabama, United States
• Pulmonary Associates, PA — Glendale, Arizona, United States
• Phoenix Medical Research Institute, LLC — Peoria, Arizona, United States
• Clinical Research Consortium — Tempe, Arizona, United States
• Center for Clinical Trials of Sacramento, Inc. — Sacramento, California, United States
• Institute of HealthCare Assessment, Inc — San Diego, California, United States
• Innovative Clinical Research — Broomfield, Colorado, United States
• IMMUNOe International Research Centers — Centennial, Colorado, United States
• Longmont Pulmonary and Critical Care — Longmont, Colorado, United States
• Ribo Research, LLC dba Peninsula Research Inc. — Ormond Beach, Florida, United States
• Progressive Medical Research — Port Orange, Florida, United States
• Pulmonary Care Research Group, PA — Winter Park, Florida, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• Duluth Biomedical Research, LLC — Duluth, Georgia, United States
• Southeast Regional Research Group — Rincon, Georgia, United States
• Asthma and Allergy Center of Chicago, SC — River Forest, Illinois, United States
• LaPorte County Institute for Clinical Research — Michigan City, Indiana, United States
• George Stanley Walker, MD — New Orleans, Louisiana, United States
• Minnesota Lung Center — Minneapolis, Minnesota, United States
• CAR.E. Clinical Research — St Louis, Missouri, United States
• The Clinical Research Center, LLC — St Louis, Missouri, United States
• Delaware Valley Clinical Research — Marlton, New Jersey, United States
• Clinical Research of Gastonia — Gastonia, North Carolina, United States
• PharmQuest — Greensboro, North Carolina, United States

Full record on ClinicalTrials.gov

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