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.

Autor:	Ikari J; Department of Respirology, Graduate School of Medicine, Chiba University, Chiba, Chiba, Japan junikari@chiba-u.jp., Katsumata M; Department of Respirology, Graduate School of Medicine, Chiba University, Chiba, Chiba, Japan., Urano A; Department of Respirology, Graduate School of Medicine, Chiba University, Chiba, Chiba, Japan., Imamoto T; Department of Respirology, Graduate School of Medicine, Chiba University, Chiba, Chiba, Japan., Suzuki Y; Department of Respirology, Graduate School of Medicine, Chiba University, Chiba, Chiba, Japan., Nishiyama A; Department of Radiology, Tsudanuma Central General Hospital, Narashino, Chiba, Japan., Yokota H; Department of Diagnostic Radiology and Radiation Oncology, Graduate School of Medicine, Chiba University, Chiba, Chiba, Japan., Ono K; Medical Imaging R&D Center, Healthcare Business Headquarters, Konica Minolta Inc, Chiyoda-ku, Tokyo, Japan., Okamoto K; Medical Imaging R&D Center, Healthcare Business Headquarters, Konica Minolta Inc, Chiyoda-ku, Tokyo, Japan., Abe E; Division of laboratory medicine, Chiba University Hospital, Chiba, Chiba, Japan., Kamata T; Division of laboratory medicine, Chiba University Hospital, Chiba, Chiba, Japan., Fujii S; Department of Radiology, Chiba University Hospital, Chiba, Chiba, Japan., Okumura K; Department of Radiology, Chiba University Hospital, Chiba, Chiba, Japan., Ota J; Department of Radiology, Chiba University Hospital, Chiba, Chiba, Japan., Suzuki E; Department of Respirology, Graduate School of Medicine, Chiba University, Chiba, Chiba, Japan., Kawata N; Department of Respirology, Graduate School of Medicine, Chiba University, Chiba, Chiba, Japan., Ozawa Y; Biostatistics Section, Clinical Research Center, Chiba University Hospital, Chiba, Chiba, Japan., Masuda Y; Department of Radiology, Chiba University Hospital, Chiba, Chiba, Japan., Matsushita K; Division of laboratory medicine, Chiba University Hospital, Chiba, Chiba, Japan., Sakao S; Department of Respirology, Graduate School of Medicine, Chiba University, Chiba, Chiba, Japan.; Department of Respiratory Medicine, international university of health and welfare, Narita, Chiba, Japan., Uno T; Department of Diagnostic Radiology and Radiation Oncology, Graduate School of Medicine, Chiba University, Chiba, Chiba, Japan., Tatsumi K; Department of Respirology, Graduate School of Medicine, Chiba University, Chiba, Chiba, Japan., Suzuki T; Department of Respirology, Graduate School of Medicine, Chiba University, Chiba, Chiba, Japan.
Jazyk:	angličtina
Zdroj:	BMJ open respiratory research [BMJ Open Respir Res] 2024 Aug 05; Vol. 11 (1). Date of Electronic Publication: 2024 Aug 05.
DOI:	10.1136/bmjresp-2024-002374
Abstrakt:	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. Competing Interests: Competing interests: KOno and KOka is currently employed full-time at KonicaMinolta.inc. None of the other authors declare any competing interests. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu