Fact CheckerSign in

NCT07103642Completed

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

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

Source: ClinicalTrials.gov · Last updated 15 Aug 2025

Brief summary (registry, in English)

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

Status (registry)
Completed
Study type
Observational
Enrollment
3402 (actual)
First submitted
29 Jul 2025
Start date
15 Aug 2024
Primary completion date
18 Oct 2024
Lead sponsor
AstraZeneca
Diseases
COPD
NCT number
NCT07103642

What you commit to

  • Study type: Observational
  • Participants enrolled: 3402
  • From 15 Aug 2024 to the primary completion date, 18 Oct 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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

Other

  • Presence of ≥ 1 dispensation of SITT during the 12-month baseline period preceding the index date through BGF initiation

Who the study is looking for

  • 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

Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
AstraZeneca
Coordinator of this site? Confirm its status
WilmingtonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.