Glycopyrrolate/formoterol fumarate MDI in mild-to-moderate chronic obstructive pulmonary disease (PIONEER): a protocol for a randomised, double-blind, placebo-controlled trial.

ABSTRACT:

Introduction

Patients with mild-to-moderate chronic obstructive pulmonary disease (COPD) often experience rapid declines in lung function but are rarely treated early. The Prospect of early InterventiON in the managEment of chronic obstructivE pulmonaRy disease (PIONEER) study aims to evaluate the efficacy of long-term glycopyrrolate/formoterol fumarate (GFF) metered dose inhaler (MDI) as an initial therapy on lung function and disease progression in individuals with mild-to-moderate COPD.

Methods and analysis

This is a multicentre, randomised, double-blind, placebo-controlled, parallel-group study. Approximately 318 patients with COPD in Global Initiative for Chronic Obstructive Lung Disease stages 1 (mild) or 2 (early moderate), with no history of severe exacerbations in t

SUBMITTER: Wang FY 

PROVIDER: S-EPMC12314815 | biostudies-literature | 2025 Jun

REPOSITORIES: biostudies-literature