Dose-response of an extrafine dry powder inhaler formulation of glycopyrronium bromide: randomized, double-blind, placebo-controlled, dose-ranging study (GlycoNEXT).

ABSTRACT:

Introduction

An extrafine formulation of the long-acting muscarinic antagonist, glycopyrronium bromide (GB), has been developed for delivery via the NEXThaler dry powder inhaler (DPI). This study assessed the bronchodilator efficacy and safety of different doses of this formulation in patients with COPD to identify the optimal dose for further development.

Patients and methods

This was a multicenter, randomized, double-blind, placebo-controlled, incomplete block, three-way crossover study, including three 28-day treatment periods, each separated by a 21-day washout period. Eligible patients had a diagnosis of COPD and post-bronchodilator forced expiratory volume in 1 s (FEV₁) 40%-70% predicted. Treatments administered were GB 6.25, 12.5, 25 and 50 μg or matched pl

SUBMITTER: Beeh KM 

PROVIDER: S-EPMC5973313 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature