Association of changes in dyspnea, lung function, and physical activity by Indacaterol/Glycopyrronium combination in patients with COPD - Changes in lung function and physical activity by LAMA/LABA therapy in COPD

Matsunaga Kazuto0 个研究点目标入组 45 人开始时间: 2018年12月27日最近更新: 2023年10月17日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方
入组人数: 45

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

Despite improvement in dyspnea and airflow limitation, PA decreased.However, PA improved in 25% of cases, and this group weretypified by strong airflow limitation. The improvement of PA may require identification of individual influencing factors, and appropriate interventions to address these influencing factors.During the study period, there was a drastic change in social conditions due to the COVID-19 pandemic, which may have had a significant impact on this study as well.

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 40age old 至 ot applicable（—）
性别: All

入选标准

•1) Written informed consent must be obtained before any assessment is performed
•2) Aged >=40 years with mild-to-moderate stable COPD
•3) A post-bronchodilator FEV1 of >=50% of the predicted normal, have a post-bronchodilator FEV1 to FVC ratio of <0.7
•4) Either current smokers or ex-smokers with a smoking history of >=10 pack-years
•5) A modified Medical Research Council (mMRC) dyspnea scale grade of at least 1

排除标准

•1) Moderate-to-severe COPD exacerbation (requiring antibiotics, systemic steroids or hospitalization) within the 4 weeks before the screening
•2) Requiring LABA and LAMA combination therapy
•3) Requiring long-term oxygen therapy
•4) Requiring short-acting beta2-agonista (SABA) relief use of more than 8 puffs/day
•5) Concomitant pulmonary disease including asthma (FeNO<50ppb at baseline)
•6) Any physical disorder that would prevent the patient from being able to complete the assessments
•7) Long QT syndrome at screening, or a clinically significant electrocardiogram abnormality
•8) History of closed angle glaucoma, and/or ischuria due to prostatic disease
•9) There is a history of hypersensitivity to components of the Urutiburo

研究者

发起方

Matsunaga Kazuto

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