Status:
COMPLETED
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
Lead Sponsor:
Sunovion Respiratory Development Inc.
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-75 years
Phase:
PHASE2
Brief 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 inves...
Detailed Description
This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, four-period, incomplete block design cross-over study using EP-101(SUN101) and open-label active controls (tiotropium brom...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT01426009
Start Date
August 1 2011
End Date
December 1 2011
Last Update
May 9 2018
Active Locations (11)
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1
Elevation Investigational Site
Phoenix, Arizona, United States, 85006
2
Elevation Investigational Site
Los Angeles, California, United States, 90048
3
Elevation Investigational Site
DeLand, Florida, United States, 32720
4
Elevation Investigational SIte
Madisonville, Kentucky, United States, 42431