Pulmonary Disease, Chronic ObstructiveEROS+CP (US)NCT06742736
EXACERBATIONS AND REAL-WORLD OUTOMES INCLUDING CARDIOPULMONARY EVENTS AMONG PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (MITOS: EROS+CP US 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 the United States 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
- 13,000 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2024to 30 Sep 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 sample will include adult (aged 40+) COPD patients who have experienced a qualifying COPD exacerbation and eventually received treatment with BGF. Patients should not have prior single inhaler triple therapy (SITT) use during the 12-month period-baseline prior to the qualifying index exacerbation and prior to initiating BGF treatment.
Who may be able to join
- 1 prescription(s) fill for BGF on or following July 24, 2020 (date of BGF approval in the United States)
- Patients must have evidence a qualifying exacerbation events which, per local or global guidelines, would qualify a patient to have treatment escalated or initiated to triple therapy. The qualifying exacerbation event must occur within the 12-month period preceding the initiation of BGF but occurring on or following local BGF commercial availability (July 24, 2020) and includes either of the following
- 12 months of continuous health plan enrollment preceding the qualifying index exacerbation event date ('baseline' period)
- 1 day of continuous enrollment following the qualifying index exacerbation date
- Age ≥ 40 years on the qualifying index exacerbation event
Who cannot join
- Presence of cancer diagnoses other than basal or squamous cell skin cancer during the baseline or follow-up periods
- Presence of interstitial fibrosis, sarcoidosis, or pulmonary embolism diagnoses during the baseline or follow-up periods
- Presence of triple therapy SITT during the baseline period through BGF initiation
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 US 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 the United States
- 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
Also called BREZTRI
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 WITHIN 181-365 DAYS OF 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; mean follow-up 462 days
Measured: Annualized rates from index exacerbation through end of data availability, mean follow-up 462 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)
Measured: Annualized rates from index exacerbation through end of data availability; mean follow-up 462 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start31 May 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 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
- 13,000 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
- NCT06742736
- Sponsor's protocol ID
- D5980R00095
- Acronym
- EROS+CP (US)
- Status last verified
- Jul 2025
- First submitted
- 16 Dec 2024
- Last updated
- 7 Aug 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 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 US Study)
- ClinicalTrials.gov ID
- NCT06742736
- Acronym / sponsor ID
- EROS+CP (US) / D5980R00095
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- COPD, Chronic Obstructive Pulmonary Disease, Retrospective, Real-World Effectiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,000 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 31 May 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 19 Dec 2024 (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 the United States
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 WITHIN 181-365 DAYS OF EXACERBATION |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The overall sample will include adult (aged 40+) COPD patients who have experienced a qualifying COPD exacerbation and eventually received treatment with BGF. Patients should not have prior single inhaler triple therapy (SITT) use during the 12-month period-baseline prior to the qualifying index exacerbation and prior to initiating BGF treatment.
Key inclusion criteria (5 listed)
- 1 prescription(s) fill for BGF on or following July 24, 2020 (date of BGF approval in the United States)
- 12 months of continuous health plan enrollment preceding the qualifying index exacerbation event date ('baseline' period)
- 1 day of continuous enrollment following the qualifying index exacerbation date
Key exclusion criteria (3 listed)
- Presence of cancer diagnoses other than basal or squamous cell skin cancer during the baseline or follow-up periods
- Presence of interstitial fibrosis, sarcoidosis, or pulmonary embolism diagnoses during the baseline or follow-up periods
- Presence of triple therapy SITT during the baseline period through BGF initiation
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 |
|---|---|---|
| BGFAlso: BREZTRIBUDESONIDE/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, mean follow-up 462 days
Annualized rates of COPD exacerbation events observed from index date (qualifying exacerbation event) through study completion (or until end of data availability; mean follow-up 462 days
1 secondary outcome
Annualized Cardiopulmonary Event Rate
Time frame: Annualized rates from index exacerbation through end of data availability; mean follow-up 462 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 7 Aug 2025.
- D5980R00095 Redacted CSR SynopsisLink provided by the sponsor.
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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 5 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 7 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, mean follow-up 462 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 7 Aug 2025.