Effects of inhaled beclometasone dipropionate/formoterol fumarate/glycopyrronium vs. beclometasone dipropionate/formoterol fumarate and placebo on lung hyperinflation and exercise endurance in chronic obstructive pulmonary disease: a randomised controlled trial.

IF 5.8 2区 医学 Q1 Medicine Respiratory Research Pub Date : 2024-10-17 DOI:10.1186/s12931-024-02993-x
Henrik Watz, Anne-Marie Kirsten, Andrea Ludwig-Sengpiel, Matthias Krüll, Robert M Mroz, George Georges, Guido Varoli, Rémi Charretier, Mauro Cortellini, Andrea Vele, Dmitry Galkin
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Abstract

Background: The single-inhaler triple combination of beclometasone dipropionate, formoterol fumarate, and glycopyrronium (BDP/FF/G) is available for maintenance therapy of chronic obstructive pulmonary disease (COPD). Cardinal features of COPD are lung hyperinflation and reduced exercise capacity. TRIFORCE aimed to evaluate the effect of BDP/FF/G on lung hyperinflation and exercise capacity in patients with COPD.

Methods: This double-blind, randomised, active- and placebo-controlled, crossover study recruited adults with COPD aged ≥ 40 years, who were hyperinflated and symptomatic, and were receiving mono- or dual inhaled maintenance COPD therapy. In the three treatment periods, patients were randomised to receive BDP/FF/G, BDP/FF, or placebo, each for 3 weeks, with a 7-10-day washout between treatment periods. Assessments included slow inspiratory spirometry (for resting inspiratory capacity [IC]) and constant work-rate cycle ergometry (for dynamic IC and exercise endurance time). The primary objective was to compare BDP/FF/G and BDP/FF vs. placebo for resting IC at Week 3. Key secondary objectives were to compare BDP/FF/G and BDP/FF vs. placebo for dynamic IC and exercise endurance time during constant work rate cycle ergometry at Week 3.

Results: Of 106 patients randomised, 95 completed the study. Resting IC adjusted mean differences vs. placebo were 315 and 223 mL for BDP/FF/G and BDP/FF, respectively (p < 0.001 for both). Adjusted mean differences vs. placebo for the key secondary endpoints were: 245 mL for dynamic IC (p < 0.001) and 69.2 s for exercise endurance time (nominal p < 0.001) with BDP/FF/G, and 96 mL (p = 0.053) and 70.1 s (nominal p < 0.001) with BDP/FF. Differences between BDP/FF/G and BDP/FF for resting and dynamic IC were 92 and 149 mL (p < 0.01 for both). All three treatments were generally well tolerated, with 27.3%, 25.3% and 19.0% of patients reporting adverse events with BDP/FF/G, BDP/FF and placebo, respectively, all mild or moderate.

Conclusions: In patients with COPD, BDP/FF/G provided significant and clinically relevant improvements vs. placebo and BDP/FF in static and dynamic hyperinflation, with an improvement vs. placebo in exercise endurance.

Trial registration: ClinicalTrials.gov (NCT05097014), registered 27th October 2021.

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吸入二丙酸倍氯米松/富马酸福莫特罗/甘草酸铵与二丙酸倍氯米松/富马酸福莫特罗和安慰剂对慢性阻塞性肺病患者肺过度充气和运动耐力的影响:随机对照试验。
背景:二丙酸倍氯米松、富马酸福莫特罗和甘草酸铵(BDP/FF/G)三合一单吸入剂可用于慢性阻塞性肺病(COPD)的维持治疗。慢性阻塞性肺病的主要特征是肺过度充气和运动能力下降。TRIFORCE 旨在评估 BDP/FF/G 对慢性阻塞性肺病患者肺过度充气和运动能力的影响:这项双盲、随机、活性和安慰剂对照的交叉研究招募了年龄≥ 40 岁的慢性阻塞性肺病成人患者,他们都有过度充气和症状,正在接受单药或双药吸入维持性慢性阻塞性肺病治疗。在三个治疗期中,患者被随机分配接受 BDP/FF/G、BDP/FF 或安慰剂治疗,每个治疗期为 3 周,治疗期之间有 7-10 天的冲洗期。评估包括慢速吸气肺活量测定法(测定静息吸气容量 [IC])和恒定工作速率循环测力法(测定动态吸气容量和运动耐力时间)。主要目标是比较 BDP/FF/G 和 BDP/FF 与安慰剂在第 3 周的静息吸气容量。主要次要目标是比较 BDP/FF/G 和 BDP/FF 与安慰剂在第 3 周的动态 IC 和恒定工作速率循环测力过程中的运动耐力时间:结果:在 106 名随机患者中,95 人完成了研究。BDP/FF/G 和 BDP/FF 与安慰剂相比,静息 IC 调整后的平均差异分别为 315 毫升和 223 毫升(P在慢性阻塞性肺病患者中,BDP/FF/G 与安慰剂和 BDP/FF 相比,在静态和动态过度充气方面有显著的临床相关性改善,与安慰剂相比,在运动耐力方面也有改善:试验注册:ClinicalTrials.gov (NCT05097014),2021 年 10 月 27 日注册。
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来源期刊
Respiratory Research
Respiratory Research RESPIRATORY SYSTEM-
CiteScore
9.70
自引率
1.70%
发文量
314
审稿时长
4-8 weeks
期刊介绍: Respiratory Research publishes high-quality clinical and basic research, review and commentary articles on all aspects of respiratory medicine and related diseases. As the leading fully open access journal in the field, Respiratory Research provides an essential resource for pulmonologists, allergists, immunologists and other physicians, researchers, healthcare workers and medical students with worldwide dissemination of articles resulting in high visibility and generating international discussion. Topics of specific interest include asthma, chronic obstructive pulmonary disease, cystic fibrosis, genetics, infectious diseases, interstitial lung diseases, lung development, lung tumors, occupational and environmental factors, pulmonary circulation, pulmonary pharmacology and therapeutics, respiratory immunology, respiratory physiology, and sleep-related respiratory problems.
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