EXACERBATIONS AND REAL-WORLD OUTOMES AMONG PATIENTS WITH COPD INITIATING BREZTRI (EROS+CP Japan Study)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

3402 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-15

Study Completion Date

2024-10-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A retrospective real-world data study, assessing the relationship between the timing of Budesonide/Glycopyrrolate/Formoterol initiation following an exacerbation and the occurrence of subsequent exacerbations, severe cardiopulmonary events and other real-world outcomes in Japan

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

EXACERBATIONS AND REAL-WORLD OUTOMES INCLUDING CARDIOPULMONARY EVENTS AMONG PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (MITOS: EROS+CP US Study)

NCT06742736

Pulmonary Disease, Chronic Obstructive

COMPLETED

Exacerbations Among Patients Receiving Breztri (EROS Study)

NCT06514144

Pulmonary Disease Chronic Obstructive Retrospective Studies

COMPLETED

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

NCT05219630

Pulmonary Disease, Chronic Obstructive

COMPLETED

A Comparative Effectiveness Study of Mortality Outcomes and Related Cardiopulmonary Events Among a Cohort of Chronic Obstructive Pulmonary Disease (COPD) Patients Who Initiate Breztri and Multiple Inhaler Triple Therapy (MITT) in the United States (US)

NCT06744374

Pulmonary Disease, Chronic Obstructive

COMPLETED

MultIceNtre Non-intERVentional Study for Efficacy,Safety Evaluation of BREZTRI in Pts With COPD in RussiA

NCT06422676

Chronic Obstructive Pulmonary Disease

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Disease, Chronic Obstructive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PROMPT

PATIENTS INITIATING BGF WITHIN 30-DAYS OF EXACERBATION

BGF

Intervention Type DRUG

BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL

DELAYED

PATIENTS INITIATING BGF WITHIN 31-180 DAYS OF EXACERBATION

BGF

Intervention Type DRUG

BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL

VERY DELAYED

PATIENTS INITIATING BGF BETWEEN 181 AND 365 DAYS AFTER EXACERBATION

BGF

Intervention Type DRUG

BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BGF

BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosis of COPD (at any position) before or on the index date

* 1 dispensation of BGF on or following the launch date of BGF in Japan
* Patients must have evidence of at least one qualifying COPD exacerbation event, which qualify the initiation of triple therapy. The exacerbation event must occur within the 12-month period preceding BGF initiation and on or after BGF launch in Japan (i.e., 04 September 2019). The earliest qualifying COPD exacerbation event will be set as the index date.

* 12 months of continuous health plan enrollment preceding the qualifying COPD exacerbation date
* 1 day of continuous enrollment following the qualifying COPD exacerbation date
* Age ≥ 40 years on the qualifying COPD exacerbation date

Exclusion Criteria

* Presence of ≥ 2 records of respiratory cancer diagnoses occurring at least 1 month apart during the 12-month baseline period preceding the qualifying COPD exacerbation or during the follow-up period
* Presence of ≥ 1 dispensation of SITT during the 12-month baseline period preceding the index date through BGF initiation
* Patients who only have 1 moderate COPD exacerbation in 12-months period prior to BGF initiation with no dispensation of long-acting inhaled COPD maintenance treatment during the 12-months baseline period preceding the qualifying COPD exacerbation.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No