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

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunovion Respiratory Development Inc.
• Treatments: Bromides; Ipratropium; Pharmaceutical Solutions; Tiotropium Bromide

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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