Pulmonary Disease, Chronic ObstructiveEROS+CP-JapanNCT07103642
EXACERBATIONS AND REAL-WORLD OUTOMES AMONG PATIENTS WITH COPD INITIATING BREZTRI (EROS+CP Japan Study)
An observational study of Pulmonary Disease, Chronic Obstructive, run by AstraZeneca at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- BGF
- How many people
- 3,402 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2024to 18 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The overall study population will include adult patients (aged ≥ 40) with COPD in Japan who have experienced a qualifying COPD exacerbation (defining the index date) on or after the BGF launch in Japan (i.e., 04 September 2019) for which triple therapy (i.e., BGF) could have been initiated per local or global guidelines
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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)
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
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- BGF
- Keywords
- COPD, Chronic Obstructive Pulmonary Disease, Retrospective, Real-World Effectiveness
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGFDrug
BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL
| Study group | Role | What they receive |
|---|---|---|
| PROMPT | PATIENTS INITIATING BGF WITHIN 30-DAYS OF EXACERBATION Receives: Drug: BGF | |
| DELAYED | PATIENTS INITIATING BGF WITHIN 31-180 DAYS OF EXACERBATION Receives: Drug: BGF | |
| VERY DELAYED | PATIENTS INITIATING BGF BETWEEN 181 AND 365 DAYS AFTER EXACERBATION Receives: Drug: BGF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized COPD Exacerbation Event Rate
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
Measured: Annualized rates from index exacerbation through end of data availability; median follow-up 713 days
Secondary outcomes (1)
Annualized Cardiopulmonary Event Rate
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.
Measured: Annualized rates from index exacerbation through end of data availability with median follow-up of 713 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start15 Aug 2024
- Primary completion18 Oct 2024
- Study completion18 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,402 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Pollack, MS, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103642
- Sponsor's protocol ID
- D5980R00093
- Acronym
- EROS+CP-Japan
- Status last verified
- Aug 2025
- First submitted
- 29 Jul 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07103642
- Acronym / sponsor ID
- EROS+CP-Japan / D5980R00093
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- COPD, Chronic Obstructive Pulmonary Disease, Retrospective, Real-World Effectiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,402 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 18 Oct 2024 (actual)
- Study completion
- 18 Oct 2024 (actual)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PROMPT | – | Drug: BGFPATIENTS INITIATING BGF WITHIN 30-DAYS OF EXACERBATION |
| DELAYED | – | Drug: BGFPATIENTS INITIATING BGF WITHIN 31-180 DAYS OF EXACERBATION |
| VERY DELAYED | – | Drug: BGFPATIENTS INITIATING BGF BETWEEN 181 AND 365 DAYS AFTER EXACERBATION |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The overall study population will include adult patients (aged ≥ 40) with COPD in Japan who have experienced a qualifying COPD exacerbation (defining the index date) on or after the BGF launch in Japan (i.e., 04 September 2019) for which triple therapy (i.e., BGF) could have been initiated per local or global guidelines
Key inclusion criteria (6 listed)
- Diagnosis of COPD (at any position) before or on the index date
- 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.
- Age ≥ 40 years on the qualifying COPD exacerbation date
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BGFBUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL | Drug | DELAYED, PROMPT, VERY DELAYED |
Primary outcome
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
1 secondary outcome
Annualized Cardiopulmonary Event Rate
Time frame: Annualized rates from index exacerbation through end of data availability with median follow-up of 713 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- D5980R00093\_CSR synopsis\_RedactedLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Pollack, MS study director
AstraZeneca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by AstraZeneca at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annualized COPD Exacerbation Event Rate (time frame: Annualized rates from index exacerbation through end of data availability; median follow-up 713 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.