CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 140 enrolled
Drug / intervention
EP-101 via nebulizer (eFlow®) 25 ug +6 moredrug
Likely dose
Tiotropium bromide via (Spiriva® Handihaler®) 18 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01426009
NCT01426009Phase 2Completed
CompareCT.gov

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

Sunovion Respiratory Development Inc.·interventional·Posted Aug 30, 2011·Updated May 9, 2018

In Brief

A Phase 2 clinical trial evaluating EP-101 via nebulizer (eFlow®) 25 ug, EP-101 via nebulizer (eFlow®) 50 ug, and 5 other interventions for Chronic Obstructive Pulmonary Disease. Completed, enrolled 140 participants across 11 sites in 2 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesUnited Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 30, 2011
Enrollment StartAug 1, 2011
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 14.8 years ago

Interventions

EP-101 via nebulizer (eFlow®) 25 ugdrug

EP-101 (25 ug ) Dose 1 administered once daily for 7 days

EP-101 via nebulizer (eFlow®) 50 ugdrug

EP-101 (50 ug ) administered once daily for 7 days

EP-101 via nebulizer (eFlow®) 100 ugdrug

EP-101 (100ug) administered once daily for 7 days

Placebo EP-101drug

Placebo EP-101 administered once daily for 7 days

Tiotropium bromide via (Spiriva® Handihaler®)drug

Tiotropium 18 µg administered once daily for 7 days using Handihaler® DPI

Ipratropium bromide Inhalation Solution via Handihaler® DPIdrug

Ipratropium 500 µg administered three times daily for 7 days using general purpose nebulizer

EP-101 via nebulizer (eFlow®) 200 ugdrug

EP-101 (200) ug administered once daily for 7 days