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OpenTrials
Completed

NCT Number: NCT07103642

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

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

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AstraZeneca

Wilmington, Delaware, 19803, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BGF

Drug

BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL

Primary outcomes

  1. Annualized COPD Exacerbation Event Rate

    Time frame: Annualized rates from index exacerbation through end of data availability; median follow-up 713 days

    Annualized rates of COPD exacerbation events observed from index date (qualifying exacerbation event) through study completion (or until end of data availability with a median follow-up of 713 days

Secondary outcomes

  1. Annualized Cardiopulmonary Event Rate

    Time frame: Annualized rates from index exacerbation through end of data availability with median follow-up of 713 days

    Annualized rates of cardiopulmonary events observed from index date (qualifying exacerbation event) through study completion (until end of data availability) with median follow-up time of 713 days.

Other outcomes

  1. Time to and rate of all-cause mortality

    Time frame: Annualized incidence of mortality from index exacerbation through end of data availability; median follow-up 713 days

    Annualized incidence of all-cause mortality observed from index date (qualifying exacerbation event) through study completion (until end of data availability with median follow-up time of 713 days.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

EXACERBATIONS AND REAL-WORLD OUTOMES INCLUDING CARDIOPULMONARY EVENTS AMONG PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE INITIATING BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL (MITOS: EROS+CP Japan Study)

Acronym: EROS+CP-Japan

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 5, 2025
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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