Change in symptom and quality of life in COPD by Budesonide/Glycopyrronium/Formoterol pressurized metered dose inhaler (BGF pMDI):a prospective, multi-centers, observational study - EBISU Study

Tanaka Michio0 个研究点目标入组 107 人开始时间: 2022年1月13日最近更新: 2024年4月1日

试验速览

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•1. Male or female patients aged >=40 years old at study entry
•2. Patients diagnosed with COPD (based on post-bronchodilator forced expiratory volume 11/flow volume curve percent predicted forced (FEV1/FVC)<70% in the past and current or former smokers with a smoking history of >=10 pack-years in the past)
•3. Patients who is on the new prescription of BGF pMDI 320/18/9.6ug twice daily as per the physician's decision, at baseline
•4. Patients with CAT>=10 at study entry
•5. Patients who are capable to fill PROs physically and/or mentally as judged by investigators
•6. Patients who provide written informed consent prior to the study entry

•1. Patients diagnosed as asthma by investigator's judgement at and/or before study entry
•2. Patients who participated in any interventional clinical studies and/or any relevant studies (quality of life (QoL) and respiratory researches) during the 12 weeks before the study entry and/or during this study
•3. Patients who used ICS+LABA+LAMA therapy including open triple and closed triple before the study entry
•4. Patients with history of exacerbation during 4 weeks before the study entry
•5. Patients with very severe comorbidities or status which would impact on QoL evaluation judged by investigators (e.g., heart failure, malignancy, receiving home oxygen therapy, pneumonia)

发起方

Tanaka Michio