Dose selection for glycopyrrolate/eFlow Phase III clinical studies: Results from GOLDEN (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer) Phase II dose-finding studies
Respiratory Research Dec 08, 2017
Donohue JF, et al. - The goal of implementing the Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer (GOLDEN) 2 and GOLDEN 6 Phase II, multicenter studies was to inform dose selection for glycopyrrolate/eFlow GOLDEN Phase III clinical trials. Based on the efficacy and safety findings, selection of glycopyrrolate 25 and 50 μg twice daily doses for the Phase III GOLDEN studies was supported and preliminary evidence was obtained for the use of nebulized glycopyrrolate as a maintenance therapy for chronic obstructive pulmonary disease.
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