A Study of the Efficacy and Safety of EP-101 ( (SUN101) in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease

Phase 2 Completed 275 enrolled Sunovion Respiratory Development Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomized, double-blind, placebo-controlled, parallel arm study. The study population will consist of subjects, 35 to 75 years of age, with a diagnosis of moderate to severe COPD per Global Initiative for Chronic Obstructive Lung Disease guidelines.

Timeline

Start: 2012-10
Primary completion: 2013-04
Completion: 2013-04

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs EP 101 12.5 mcg; p = 0.0043; Least Squares Mean (SE) 0.1168 (95% CI 0.0369 to 0.1966); NCT01706536 ↗

registry analysis (superiority test); Placebo vs EP-101 25 mcg; p = 0.0019; Least Squares Mean (SE) 0.1284 (95% CI 0.0479 to 0.2089); NCT01706536 ↗

registry analysis (superiority test); Placebo vs EP-101 50 mcg; p = 0.0004; Least Squares Mean (SE) 0.1462 (95% CI 0.0667 to 0.2257); NCT01706536 ↗

registry analysis (superiority test); EP-101 100 mcg; p <0.0001; Least Squares Mean (SE) 0.1770 (95% CI 0.0992 to 0.2548); NCT01706536 ↗

Publications

Results Donohue JF, Goodin T, Tosiello R, Wheeler A. Dose selection for glycopyrrolate/eFlow(R) phase III clinical studies: results from GOLDEN (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer) phase II dose-finding studies. Respir Res. 2017 Dec 4;18(1):202. doi: 10.1186/s12931-017-0681-z.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	EP-101	Unknown	12.5 ug	Other
Subject	EP-101	Unknown	25 ug	Other
Subject	EP-101	Unknown	50 ug	Other
Subject	EP-101	Unknown	100 ug	Other