Study to Investigate the Dose Response, Safety and Efficacy of Nebulized EP-101(SUN101) in Patients With Chronic Obstructive Pulmonary Disease (COPD): GOLDEN-1 Study

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

The purpose of this study is to determine steady-state efficacy and dose response profile and to assess safety and pharmacokinetic profile of nebulized EP-101(SUN101) after 7-day dosing using an investigational high efficiency nebulizer (eFlow®) compared with placebo and two active comparators in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).

Key facts

Study ID

NCT01426009

Run by

Sunovion Respiratory Development Inc.

People needed

140

Starts

2011-08-01

Expected to finish

2011-12-01

Last updated by the study team

2018-05-09

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 40-75 years of age
• Clinical diagnosis of moderate to severe COPD
• Current/ex-smokers with at least 10 pack-year smoking history
• Post-bronchodilator FEV1 ≥ 30% and ≤ 70% predicted normal values
• Post-bronchodilator FEV1/FVC ratio of ≤ 0.70
• Post-bronchodilator improvement in FEV1 ≥ 12% and ≤ 30%, and a minimum of 100 mL
• Willing and able to remain at the study site for at least 24 hours at each study visit
• Signed written informed consent

You may not qualify if…

• Current evidence or recent history of any clinically significant and unstable disease or abnormality (e.g., myocardial infarction, cardiac failure, uncontrolled hypertension, life-threatening arrhythmias, uncontrolled diabetes)
• Primary diagnosis of asthma
• History of malignancy within the past 5 years
• History of COPD exacerbation within 6 weeks of Screening
• Daily oxygen therapy > 10 hours per day
• Systemic steroids use within 6 weeks of Screening
• Respiratory tract infection within 6 weeks of Screening
• History of tuberculosis, bronchiectasis
• History of urinary retention or bladder neck obstruction type symptoms
• History of glaucoma
• Prolonged QTc interval (>460msec) or history of long QT syndrome
• Recent history of alcohol or drug abuse
• Females who are pregnant or breastfeeding, or if of child-bearing potential unwilling to practice acceptable birth control methods
• History of hypersensitivity or intolerance to aerosol medications
• Participation in another investigational drug study within 30 days of Screening

Where it is running

• Elevation Investigational Site — Phoenix, Arizona, United States
• Elevation Investigational Site — Los Angeles, California, United States
• Elevation Investigational Site — DeLand, Florida, United States
• Elevation Investigational SIte — Madisonville, Kentucky, United States
• Elevation Investigational Site — North Dartmouth, Massachusetts, United States
• Elevation Investigational Site — Charlotte, North Carolina, United States
• Elevation Investigational Site — Raleigh, North Carolina, United States
• Elevation Investigational Site — Medford, Oregon, United States
• Elevation Investigational Site — Spartanburg, South Carolina, United States
• Elevation Investigational Site — Tacoma, Washington, United States
• Elevation Investigational Site — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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