Efficacy and safety of four doses of glycopyrrolate/formoterol fumarate delivered via a metered dose inhaler compared with the monocomponents in patients with moderate-to-severe COPD.

ABSTRACT:

Purpose

To determine the efficacy and safety of glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI 36/9.6, 36/7.2, 18/9.6, 9/9.6 µg) using innovative co-suspension delivery technology, compared with glycopyrrolate (GP) MDI 36 µg and formoterol fumarate (FF) MDI 9.6 µg, in patients with moderate-to-severe COPD.

Methods

In this Phase IIb, randomized, double-blind, balanced incomplete-block, two-period, cross-over study (NCT01349816), patients received treatment twice-daily for 7 days. The primary efficacy endpoint was forced expiratory volume in 1 second (FEV₁) area under the curve from 0 to 12 hours (AUC_0-12) on Day 7. Secondary efficacy endpoints were peak change from baseline in FEV₁ through 2 hours; time to onset of action (≥1

SUBMITTER: Reisner C 

PROVIDER: S-EPMC6016010 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature