A Dose-Range Finding Study of SUN-101 in Subjects With Moderate to Severe COPD

NCT02038829 ↗

Phase 2 Completed 96 enrolled Sunovion Respiratory Development Inc.

RandomizedCrossoverQuadruple-blindTreatment

Summary

Study for subjects 40 to 65 years-old with a diagnosis of moderate to severe COPD. Aclidinium bromide 400 mcg 2x a day will be given as an active comparator.

Timeline

Start: 2014-01
Primary completion: 2014-05
Completion: 2014-05

Outcome

Met primary endpoint

registry Placebo vs SUN-101 6.25 mcg; p = 0.0014; LS Mean (SE) 0.0822 (95% CI 0.0380 to 0.1264) NCT02038829 ↗

registry Placebo vs SUN-101 12.5 mcg; p <0.0001; LS Mean (SE) 0.1088 (95% CI 0.0644 to 0.1532) NCT02038829 ↗

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
Comparator	Aclidinium	Unknown	400 ug	—
Subject	IVOSPEMIN	Other / unclassified	3 ug	Other
Subject	IVOSPEMIN	Other / unclassified	6.25 ug	Other
Subject	IVOSPEMIN	Other / unclassified	12.5 ug	Other
Subject	IVOSPEMIN	Other / unclassified	50 ug	Other