{"title":"甘罗酸/富马酸福莫特罗MDI治疗轻至中度慢性阻塞性肺疾病(PIONEER):一项随机、双盲、安慰剂对照试验方案","authors":"Feng-Yan Wang, Zi-Hui Wang, Jia-Xuan Xu, Zhen-Yu Liang, Pi-Xin Ran, Yu-Min Zhou, Yi Gao, Wei-Juan Shi, Wan-Yi Jiang, Yu-Qi Li, Dong-Ying Zhang, Rong-Chang Chen, Wei-Jie Guan, Nan-Shan Zhong, Jin-Ping Zheng","doi":"10.1136/bmjresp-2024-002656","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods and analysis: </strong>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 (FEV<sub>1</sub>) 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 FEV<sub>1</sub> over 24 weeks, morning post-dose 2 hour FEV<sub>1</sub> 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.</p><p><strong>Trial registration number: </strong>ChiCTR2200064765; Chinese Clinical Trial Registry, www.chictr.org.cn.</p><p><strong>Ethics and dissemination: </strong>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.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"12 1","pages":""},"PeriodicalIF":3.4000,"publicationDate":"2025-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12314815/pdf/","citationCount":"0","resultStr":"{\"title\":\"Glycopyrrolate/formoterol fumarate MDI in mild-to-moderate chronic obstructive pulmonary disease (PIONEER): a protocol for a randomised, double-blind, placebo-controlled trial.\",\"authors\":\"Feng-Yan Wang, Zi-Hui Wang, Jia-Xuan Xu, Zhen-Yu Liang, Pi-Xin Ran, Yu-Min Zhou, Yi Gao, Wei-Juan Shi, Wan-Yi Jiang, Yu-Qi Li, Dong-Ying Zhang, Rong-Chang Chen, Wei-Jie Guan, Nan-Shan Zhong, Jin-Ping Zheng\",\"doi\":\"10.1136/bmjresp-2024-002656\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>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.</p><p><strong>Methods and analysis: </strong>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 (FEV<sub>1</sub>) 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 FEV<sub>1</sub> over 24 weeks, morning post-dose 2 hour FEV<sub>1</sub> over 52 weeks and time to minimal clinically important deterioration. The safety endpoint is the incidence of adverse events. 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引用次数: 0
摘要
轻至中度慢性阻塞性肺疾病(COPD)患者经常经历肺功能的快速下降,但很少早期治疗。慢性阻塞性肺疾病管理早期干预前景(PIONEER)研究旨在评估长期甘罗酸/富马酸福莫特罗(GFF)计量吸入器(MDI)作为轻至中度COPD患者肺功能和疾病进展的初始治疗的疗效。方法与分析:这是一项多中心、随机、双盲、安慰剂对照、平行组研究。大约318名慢性阻塞性肺疾病全球倡议1期(轻度)或2期(早期中度)COPD患者,前一年无严重恶化史,将按2:1的比例随机分组,接受每天两次GFF MDI(14.4/10µg)或安慰剂,持续52周。临床评估将包括肺功能测试、症状评分、生活质量测量、COPD恶化记录和胸部CT。主要终点是24周内使用支气管扩张剂2小时后1 s用力呼气量(FEV1)与基线变化的组间差异。次要终点包括24周内早晨服药前至服药后2小时FEV1从基线变化的组间差异,52周内早晨服药后2小时FEV1的变化以及达到临床重要恶化最小的时间。安全性终点是不良事件的发生率。在PIONEER研究之后,将进行一项再随机化的扩展研究,以探索GFF MDI使用的长期需求。试验注册号:ChiCTR2200064765;中国临床试验注册中心(www.chictr.org.cn.Ethics)和传播:研究方案已获得广州医科大学第一附属医院伦理委员会(2022- 23,2024 - k -005)的批准,所有合作中心已获得各自伦理委员会的批准。研究结果将在国内和国际会议上提出,并提交在该领域同行评议的期刊上发表。
Glycopyrrolate/formoterol fumarate MDI in mild-to-moderate chronic obstructive pulmonary disease (PIONEER): a protocol for a randomised, double-blind, placebo-controlled trial.
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.
期刊介绍:
BMJ Open Respiratory Research is a peer-reviewed, open access journal publishing respiratory and critical care medicine. It is the sister journal to Thorax and co-owned by the British Thoracic Society and BMJ. The journal focuses on robustness of methodology and scientific rigour with less emphasis on novelty or perceived impact. BMJ Open Respiratory Research operates a rapid review process, with continuous publication online, ensuring timely, up-to-date research is available worldwide. The journal publishes review articles and all research study types: Basic science including laboratory based experiments and animal models, Pilot studies or proof of concept, Observational studies, Study protocols, Registries, Clinical trials from phase I to multicentre randomised clinical trials, Systematic reviews and meta-analyses.