NCT05219630: EBISU

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

Completed Last updated 23 April 2024

What this trial tests

trial in Pulmonary Disease, Chronic Obstructive in 106 participants. Completed in 30 May 2023.

Timeline

16 May 2022

Primary endpoint
30 May 2023

30 May 2023

Quick facts

Lead sponsor	AstraZeneca
Status	Completed
Study type	OBSERVATIONAL
Enrollment	106
Start date	16 May 2022
Primary completion	30 May 2023
Estimated completion	30 May 2023
Sites	17 locations across Japan

Conditions studied

• Pulmonary Disease, Chronic Obstructive — all drugs for Pulmonary Disease, Chronic Obstructive →

Sponsor

AstraZeneca — full company profile →

Who can join

40 and older, any sex, with Pulmonary Disease, Chronic Obstructive. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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-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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Real-world effectiveness of budesonide/glycopyrronium/formoterol fumarate metered dose inhaler on symptoms and quality of life in patients with COPD: EBISU study.
   Muro S, Hozawa S, Sugiura H, Yoshida Y, et al · · 2025 · PMID 40513294 · DOI 10.1016/j.resinv.2025.05.007