噻托溴铵/奥洛他特罗联合疗法对慢性阻塞性肺病疗效的动态胸片评估:一项开放标签、前瞻性、单中心、非对照、对比研究的 EMBODY 研究方案。

IF 3.6 3区 医学 Q1 RESPIRATORY SYSTEM BMJ Open Respiratory Research Pub Date : 2024-08-05 DOI:10.1136/bmjresp-2024-002374
Jun Ikari, Megumi Katsumata, Akira Urano, Takuro Imamoto, Yuri Suzuki, Akira Nishiyama, Hajime Yokota, Kojiro Ono, Kentaro Okamoto, Eriko Abe, Tomoko Kamata, Shota Fujii, Kenichiro Okumura, Joji Ota, Eiko Suzuki, Naoko Kawata, Yoshihito Ozawa, Yoshitada Masuda, Kazuyuki Matsushita, Seiichiro Sakao, Takashi Uno, Koichiro Tatsumi, Takuji Suzuki
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引用次数: 0

摘要

导言:迄今为止,关于支气管扩张剂对慢性阻塞性肺病(COPD)呼吸动力学影响的证据还很有限。动态胸部放射成像(DCR)是一种新型放射成像模式,可提供实时、客观和可量化的动力学数据,包括呼吸过程中肺面积(Rs)、气管直径、膈肌动力学和肺通气的变化,其辐射剂量低于透视或 CT 成像。目的:本研究旨在使用 DCR 评估支气管扩张剂治疗对慢性阻塞性肺疾病患者呼吸动力学的影响:这是一项开放标签、前瞻性、单中心、非对照、对比研究。共将招募 35 名慢性阻塞性肺病患者,年龄在 40-85 岁之间,第一秒用力呼气容积为 30-80%。经过 2-4 周的冲洗期后,患者将接受为期 6 周的噻托溴铵/olodaterol 治疗。治疗效果将根据治疗前后的 DCR 结果、肺功能测试结果和患者相关结果进行评估。主要终点是治疗后 Rs 的变化。次要终点包括治疗前和治疗后其他 DCR 参数(膈肌动力学、气管直径变化和最大像素值变化率)、肺功能测试结果和患者相关结果之间的差异。将报告所有不良事件:本研究已获得千叶大学医院伦理委员会的伦理批准。本试验的结果将发表在同行评审期刊上。试验注册号:jRCTs032210543。
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Dynamic chest radiographic evaluation of the effects of tiotropium/olodaterol combination therapy in chronic obstructive pulmonary disease: the EMBODY study protocol for an open-label, prospective, single-centre, non-controlled, comparative study.

Introduction: To date, there is limited evidence on the effects of bronchodilators on respiratory dynamics in chronic obstructive pulmonary disease (COPD). Dynamic chest radiography (DCR) is a novel radiographic modality that provides real-time, objective and quantifiable kinetic data, including changes in the lung area (Rs), tracheal diameter, diaphragmatic kinetics and pulmonary ventilation during respiration, at a lower radiation dose than that used by fluoroscopic or CT imaging. However, the therapeutic effect of dual bronchodilators on respiratory kinetics, such as chest wall dynamics and respiratory muscle function, has not yet been prospectively evaluated using DCR.

Aim: This study aims to evaluate the effects of bronchodilator therapy on respiratory kinetics in patients with COPD using DCR.

Methods and analysis: This is an open-label, prospective, single-centre, non-controlled, comparative study. A total of 35 patients with COPD, aged 40-85 years, with a forced expiratory volume in the first second of 30-80%, will be enrolled. After a 2-4 weeks washout period, patients will receive tiotropium/olodaterol therapy for 6 weeks. Treatment effects will be evaluated based on DCR findings, pulmonary function test results and patient-related outcomes obtained before and after treatment. The primary endpoint is the change in Rs after therapy. The secondary endpoints include differences in other DCR parameters (diaphragmatic kinetics, tracheal diameter change and maximum pixel value change rate), pulmonary function test results and patient-related outcomes between pre-therapy and post-therapy values. All adverse events will be reported.

Ethics and dissemination: Ethical approval for this study was obtained from the Ethics Committee of Chiba University Hospital. The results of this trial will be published in a peer-reviewed journal.

Trial registration number: jRCTs032210543.

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来源期刊
BMJ Open Respiratory Research
BMJ Open Respiratory Research RESPIRATORY SYSTEM-
CiteScore
6.60
自引率
2.40%
发文量
95
审稿时长
12 weeks
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.
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