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© 2025 Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

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 the previous year, will be randomised in a 2:1 ratio to receive two times per day GFF MDI (14.4/10 µg) or placebo for 52 weeks. Clinical assessments will include pulmonary function tests, symptom scores, quality-of-life measures, recording of COPD exacerbations and chest CT. The primary endpoint is the between-group difference in the change from baseline in forced expiratory volume in 1 s (FEV1) after 2 hours of bronchodilator over 24 weeks. Secondary endpoints include the between-group difference in the change from baseline in morning pre-dose trough FEV1 over 24 weeks, morning post-dose 2 hour FEV1 over 52 weeks and time to minimal clinically important deterioration. The safety endpoint is the incidence of adverse events. An extension study with rerandomisation will follow the PIONEER study to explore the long-term need for GFF MDI use.

Trial registration number

ChiCTR2200064765; Chinese Clinical Trial Registry, www.chictr.org.cn.

Ethics and dissemination

The study protocol has been approved by the Ethics Committee of The First Affiliated Hospital, Guangzhou Medical University (2022-23、2024-K-005), and all collaborating centres have obtained approval from their respective ethics committees. Results will be presented at national and international meetings and submitted for publication in peer-reviewed journals within the field.

Details

Title
Glycopyrrolate/formoterol fumarate MDI in mild-to-moderate chronic obstructive pulmonary disease (PIONEER): a protocol for a randomised, double-blind, placebo-controlled trial
Author
Feng-Yan, Wang 1   VIAFID ORCID Logo  ; Zi-Hui, Wang 1 ; Jia-Xuan, Xu 1 ; Zhen-Yu, Liang 1 ; Pi-Xin Ran 2   VIAFID ORCID Logo  ; Yu-Min, Zhou 2   VIAFID ORCID Logo  ; Gao, Yi 1 ; Wei-Juan, Shi 1 ; Wan-Yi, Jiang 1 ; Yu-Qi, Li 1 ; Dong-Ying, Zhang 1 ; Rong-Chang, Chen 3 ; Wei-Jie, Guan 2   VIAFID ORCID Logo  ; Nan-Shan Zhong 2 ; Jin-Ping, Zheng 2 

 Department of Respiratory and Critical Care Medicine, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, National Center for Respiratory Medicine, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital, Guangzhou Medical University, The First Affiliated Hospital, Guangzhou Medical University, Guangzhou, Guangdong, China 
 Department of Respiratory and Critical Care Medicine, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, National Center for Respiratory Medicine, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital, Guangzhou Medical University, The First Affiliated Hospital, Guangzhou Medical University, Guangzhou, Guangdong, China; Guangzhou National Laboratory, Guangzhou, China 
 Department of Respiratory and Critical Care Medicine, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, National Center for Respiratory Medicine, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital, Guangzhou Medical University, The First Affiliated Hospital, Guangzhou Medical University, Guangzhou, Guangdong, China; Hetao Institute of Guangzhou National Laboratory, Shenzhen, China 
First page
e002656
Section
Chronic obstructive pulmonary disease
Publication year
2025
Publication date
2025
Publisher
BMJ Publishing Group LTD
e-ISSN
20524439
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
3222653659
Copyright
© 2025 Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.