NCT01426009

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

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Seven Arm, Four-Period Cross-over, Incomplete Block Design, 7-Day Dosing Study to Assess the Dose-Response, Safety, and Efficacy of EP-101 (SUN101) in Subjects With Moderate to Severe COPD

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Sunovion Respiratory Development Inc. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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).

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 bromide and ipratropium bromide). The study population will consist of subjects of 40-75 years of age with moderate to severe COPD. Approximately 133 subjects diagnosed with moderate to severe COPD will be enrolled in order to achieve minimum 105 subjects completing the study. Following a run-in phase, each subject will be randomly assigned to one of 7 treatment sequences,(96 sequences when order of administration is considered), with each sequence comprised of four 7-day Treatment Periods. There will be a washout period of 7 days between each Treatment Period. Study visits will be conducted on Days 1 and 7 of each Treatment Period, with an overnight stay required in the clinic during these visits. A Final Study Visit will be conducted 7 days following the last study treatment. During each Treatment Period, study treatments will be administered once daily (QD), except for ipratropium inhalation solution, which will be administered three times daily (TID). EP-101 (SUN101)active and placebo treatments will be administered using an investigational high-efficiency eFlow® nebulizer. Tiotropium bromide (Spiriva®) will be administered in an open-label manner via Handihaler® dry-powder inhaler (DPI). Ipratropium bromide inhalation solution will be administered in an open-label manner via general purpose nebulizer. This study was previously posted by Elevation Pharmaceuticals, Inc. On September 5, 2012, Elevation was acquired by merger with Sunovion Pharmaceuticals Inc. ("Sunovion"), which resulted in Elevation becoming a direct wholly-owned subsidiary of Sunovion. In conjunction with this acquisition, the name of Elevation has been changed to Sunovion Respiratory Development Inc.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	EP-101 via nebulizer (eFlow®) 25 ug	EP-101 (25 ug ) Dose 1 administered once daily for 7 days
DRUG	EP-101 via nebulizer (eFlow®) 50 ug	EP-101 (50 ug ) administered once daily for 7 days
DRUG	EP-101 via nebulizer (eFlow®) 100 ug	EP-101 (100ug) administered once daily for 7 days
DRUG	Placebo EP-101	Placebo EP-101 administered once daily for 7 days
DRUG	Tiotropium bromide via (Spiriva® Handihaler®)	Tiotropium 18 µg administered once daily for 7 days using Handihaler® DPI
DRUG	Ipratropium bromide Inhalation Solution via Handihaler® DPI	Ipratropium 500 µg administered three times daily for 7 days using general purpose nebulizer
DRUG	EP-101 via nebulizer (eFlow®) 200 ug	EP-101 (200) ug administered once daily for 7 days

Timeline

• Start date: 2011-08-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2011-08-30
• Last updated: 2018-05-09
• Results posted: 2018-05-07

Locations

11 sites across 2 countries: United States, United Kingdom