Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
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
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).
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.
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