{"title":"一项探索性、随机、开放标签、多中心临床试验的基本原理和设计,研究长效β2激动剂/长效毒蕈碱拮抗剂对心力衰竭合并慢性阻塞性肺疾病(COPD-HF试验)的疗效。","authors":"Hiroya Hayashi, Shin Ito, Hiroki Fukuda, Makoto Sata, Yukio Abe, Kohei Fujimoto, Daiju Fukuda, Yohei Hanajima, Mutsuo Horii, Noriyuki Ikehara, Moriaki Inoko, Chisato Izumi, Yasuhiro Izumiya, Takafumi Nakayama, Takashi Sozu, Shigeru Toyoda, Masafumi Watanabe, Masashi Yokoi, Masafumi Kitakaze","doi":"10.1253/circrep.CR-25-0010","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Chronic obstructive pulmonary disease (COPD) is one of the most common comorbidities in patients with chronic heart failure (CHF). A growing number of patients are suffering from both COPD and CHF, and these conditions worsen each other. Inhaled bronchodilator therapy with long-acting muscarinic antagonist (LAMA) and long-acting β2-agonist (LABA) in combination is currently the mainstay of treatment for COPD. However, the effect of LAMA/LABA on HF with COPD remains unknown.</p><p><strong>Methods and results: </strong>The COPD-HF trial is a multicenter, double-arm, open-label, exploratory, investigator-initiated clinical study to investigate the effect of LAMA/LABA on HF in patients suffering from both COPD and CHF. The participants are randomly assigned (1 : 1) to the LAMA/LABA (tiotropium+olodaterol FDC (fixed-dose combination) 5/5 ug) group (once a day, 2 inhalations) or non-pharmacological treatments for COPD as a control group. The planned number of patients to be enrolled in this trial is 54 in total (27 in each group). The participants are followed up for 12 weeks with and without LAMA/LABA. The primary endpoint is the change in plasma B-type natriuretic peptide levels from the baseline to the end of this study (12 weeks).</p><p><strong>Conclusions: </strong>The COPD-HF trial will investigate the efficacy of LAMA/LABA on HF in patients with COPD and CHF.</p>","PeriodicalId":94305,"journal":{"name":"Circulation reports","volume":"7 5","pages":"383-388"},"PeriodicalIF":0.0000,"publicationDate":"2025-04-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12061507/pdf/","citationCount":"0","resultStr":"{\"title\":\"Rationale and Design of an Exploratory, Randomized, Open-Label, Multicenter Clinical Trial to Investigate the Efficacy of Long-Acting β2-Agonist/Long-Acting Muscarinic Antagonist on Heart Failure Complicated by Chronic Obstructive Pulmonary Disease (COPD-HF Trial).\",\"authors\":\"Hiroya Hayashi, Shin Ito, Hiroki Fukuda, Makoto Sata, Yukio Abe, Kohei Fujimoto, Daiju Fukuda, Yohei Hanajima, Mutsuo Horii, Noriyuki Ikehara, Moriaki Inoko, Chisato Izumi, Yasuhiro Izumiya, Takafumi Nakayama, Takashi Sozu, Shigeru Toyoda, Masafumi Watanabe, Masashi Yokoi, Masafumi Kitakaze\",\"doi\":\"10.1253/circrep.CR-25-0010\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Chronic obstructive pulmonary disease (COPD) is one of the most common comorbidities in patients with chronic heart failure (CHF). A growing number of patients are suffering from both COPD and CHF, and these conditions worsen each other. Inhaled bronchodilator therapy with long-acting muscarinic antagonist (LAMA) and long-acting β2-agonist (LABA) in combination is currently the mainstay of treatment for COPD. However, the effect of LAMA/LABA on HF with COPD remains unknown.</p><p><strong>Methods and results: </strong>The COPD-HF trial is a multicenter, double-arm, open-label, exploratory, investigator-initiated clinical study to investigate the effect of LAMA/LABA on HF in patients suffering from both COPD and CHF. The participants are randomly assigned (1 : 1) to the LAMA/LABA (tiotropium+olodaterol FDC (fixed-dose combination) 5/5 ug) group (once a day, 2 inhalations) or non-pharmacological treatments for COPD as a control group. The planned number of patients to be enrolled in this trial is 54 in total (27 in each group). The participants are followed up for 12 weeks with and without LAMA/LABA. The primary endpoint is the change in plasma B-type natriuretic peptide levels from the baseline to the end of this study (12 weeks).</p><p><strong>Conclusions: </strong>The COPD-HF trial will investigate the efficacy of LAMA/LABA on HF in patients with COPD and CHF.</p>\",\"PeriodicalId\":94305,\"journal\":{\"name\":\"Circulation reports\",\"volume\":\"7 5\",\"pages\":\"383-388\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-04-12\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12061507/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Circulation reports\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1253/circrep.CR-25-0010\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/5/9 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Circulation reports","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1253/circrep.CR-25-0010","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/5/9 0:00:00","PubModel":"eCollection","JCR":"","JCRName":"","Score":null,"Total":0}
Rationale and Design of an Exploratory, Randomized, Open-Label, Multicenter Clinical Trial to Investigate the Efficacy of Long-Acting β2-Agonist/Long-Acting Muscarinic Antagonist on Heart Failure Complicated by Chronic Obstructive Pulmonary Disease (COPD-HF Trial).
Background: Chronic obstructive pulmonary disease (COPD) is one of the most common comorbidities in patients with chronic heart failure (CHF). A growing number of patients are suffering from both COPD and CHF, and these conditions worsen each other. Inhaled bronchodilator therapy with long-acting muscarinic antagonist (LAMA) and long-acting β2-agonist (LABA) in combination is currently the mainstay of treatment for COPD. However, the effect of LAMA/LABA on HF with COPD remains unknown.
Methods and results: The COPD-HF trial is a multicenter, double-arm, open-label, exploratory, investigator-initiated clinical study to investigate the effect of LAMA/LABA on HF in patients suffering from both COPD and CHF. The participants are randomly assigned (1 : 1) to the LAMA/LABA (tiotropium+olodaterol FDC (fixed-dose combination) 5/5 ug) group (once a day, 2 inhalations) or non-pharmacological treatments for COPD as a control group. The planned number of patients to be enrolled in this trial is 54 in total (27 in each group). The participants are followed up for 12 weeks with and without LAMA/LABA. The primary endpoint is the change in plasma B-type natriuretic peptide levels from the baseline to the end of this study (12 weeks).
Conclusions: The COPD-HF trial will investigate the efficacy of LAMA/LABA on HF in patients with COPD and CHF.