Change in Symptom and Quality of Life in COPD by Budesonide/Glycopyrronium/Formoterol Fumarate Pressurized Metered Dose Inhaler (BGF pMDI) — EBISU  

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title: Change in Symptom and Quality of Life in COPD by Budesonide/Glycopyrronium/Formoterol Fumarate Pressurized Metered Dose Inhaler (BGF pMDI)

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 weeks will be used to assess immediate onset of benefits while the full study length will serve to demonstrate durability in response. To help contextualize the study result, KRONOS data will be referred where applicable.

Study Design:

This is a 12-week, prospective, multi-center, 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 physician in their routine clinical care will be consecutively invited for this study.

The day of the initiation of BGF pMDI treatment is called baseline, and the timing of fulfilling the eligibility criteria at baseline day is called the study entry.

Investigators (physicians) make screening their candidate patients who will be on the new prescription of BGF pMDI prior to the study entry and make explanation on informed consent at their usual visit timing. 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 [Week 3 (Day 21) to Week 7 (Day 49)] and week 12 [Week 10 (Day 70) to Week 14 (Day 98)].

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. ;

Related Conditions & MeSH terms

• Pulmonary Disease, Chronic Obstructive

• NCT number: NCT05219630
• Study type: Observational
• Source: AstraZeneca
• Status: Completed
• Start date: May 16, 2022
• Completion date: May 30, 2023