Comparative efficacy and safety of glycopyrronium/formoterol fixed-dose combination versus glycopyrronium monotherapy in patients with moderate-to–severe COPD

ABSTRACT: ABSTRACT

Background:

The safety and efficacy of fixed-dose combination (FDC) of glycopyrronium bromide 12.5 mg/formoterol fumarate 12 mg (GB/FF) twice daily as dry powder inhalers (DPIs) compared to glycopyrronium 50 mg monotherapy (GLY) once daily as DPI in subjects with moderate-to-severe chronic obstructive pulmonary disease (COPD) were evaluated.

Methods:

This was a phase-3, randomized, double-blind, active-controlled, parallel-group, superiority study conducted in India. COPD patients aged ≥40 to ≤65 years, current or ex-smokers with FEV1/FVC <0.70, using ICS, LAMA, or LABA for ≥1 month were included. Subjects were randomized (1:1) to GB/FF or GLY for 12 weeks. The primary efficacy endpoint was the change from baseline in peak FEV1 at the end of 12 weeks. The study i

SUBMITTER: Salvi S 

PROVIDER: S-EPMC9746267 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature