ブデソニド/グリコピロニウム/ホルモテロールフマル酸塩加圧式定量吸入器（BGF pMDI）によるCOPD患者の症状および生活の質の変化
基本情報
- NCT ID
- NCT05219630
- ステータス
- 完了
- 試験のフェーズ
- -
- 試験タイプ
- 観察
- 目標被験者数
- 106
- 治験依頼者名
- AstraZeneca
概要
This study is primarily aimed to investigate whether PROs can be improved after the initiation of BGF pMDI in real world clinical settings. While the study is 12-weeks in duration, the initial 4-week period will be used to assess immediate onset of benefits while the full study length will serve to demonstrate durability in response. Study design: This is a 12-week, multi-center, prospective observational study in which a total number of 107 patients will be enrolled. Adult outpatients with COPD without asthma history and who initiate on BGF pMDI as decided by the physicians in their routine clinical care will be consecutively invited for this study. Investigators (physicians) make screening their patients prior to the study entry and make informed consent explanation at their usual visit timing to the all eligible patients. After fulfilling eligibility criteria at study entry, the patients are enrolled in the study and the investigators will follow up the patients as in routine clinical practice and collect the data at baseline, at week 4 and week 12. Data Source(s): The study sites will be selected where BGF pMDI is used as a treatment option for COPD patients. Investigators participating in the study evaluate lung function (i.e., spirometry) for COPD patients in a daily practice Statistical Analysis: All data including patient characteristics at baseline will be summarized using appropriate descriptive statistics. Where applicable, changes from baseline at each timepoint will also be summarized using descriptive statistics. A comprehensive statistical analysis plan (SAP) including more details will be prepared prior to the database lock.