Chronic Obstructive Pulmonary DiseaseNCT07414134
Exacerbations and Real-World Outcomes Among Patients With Chronic Obstructive Pulmonary Disease Following Severe Exacerbation
An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 1 site in United States.
Trial summary
This real-world retrospective study will use de-identified administrative claims data and will examine patients with a diagnosis of COPD who have experienced a qualifying severe disease exacerbation and received subsequent treatment with BGF. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- BGF- BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL
- How many people
- 3,598 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2025to 28 Nov 2025
- 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 study population is selected to allow a clear comparison of outcomes according to the timing of BGF initiation following a severe COPD exacerbation. The overall sample will include adult (aged ≥40) patients with COPD who have experienced a qualifying severe COPD exacerbation and received treatment with BGF within 6 months. Patients should not have prior single inhaler triple therapy (SITT) use during the available history of patients' data preceding the qualifying index severe exacerbation and prior to initiating BGF treatment.
Who may be able to join
- ≥ 1 prescription(s) fill for BGF on or following January 1, 2021
- Patients must have evidence of a severe qualifying exacerbation event.
- The qualifying severe exacerbation event discharge date must occur within the 180-day period preceding the initiation of BGF for classification of patients into prompt or delayed initiators of BGF.
- The discharge date of the first (earliest) observed qualifying index exacerbation event will be set as the index date
- ≥ 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 date
Who cannot join
- Presence of cancer diagnoses other than basal or squamous cell skin cancer during the baseline period preceding the index date or entire follow-up period
- Presence of ≥2 claims with a diagnosis of interstitial fibrosis or sarcoidosis diagnoses during the period preceding the index date or entire follow-up period
- Presence of SITT at any time during the entire available history of patients' data preceding the index date through BGF initiation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exacerbations and Real-World Outcomes Among Patients With Chronic Obstructive Pulmonary Disease Following Severe Exacerbation (MITOS:EROS+DISCHARGE)
This real-world retrospective study will use de-identified administrative claims data and will examine patients with a diagnosis of COPD who have experienced a qualifying severe disease exacerbation and received subsequent treatment with BGF. Agreed COPD patient data from the Inovalon MORE2 Registry® and Centers for Medicare \& Medicaid Services (CMS) 100% Medicare Fee for Service (FFS) database spanning from January 1, 2021 to the most recently available data (September 30th, 2024 for the MORE2 database, and December 31st, 2023 for the Medicare FFS database) will be used for this analysis. All patients will be required to present at least one prescription claim for BGF. Patients will also be required to show evidence of a qualifying severe COPD exacerbation event during the 180-day period preceding initiation of BGF. Index date will be set as the date of discharge from the qualifying severe exacerbation event.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- BGF- BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL
- 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.
BGF- BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROLDrug
This is a real-world observational study evaluating the timing of BGF, post discharge.
| Study group | Role | What they receive |
|---|---|---|
| Prompt | Patients initiating BGF within 30-days of exacerbation Receives: Drug: BGF- BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL | |
| Delayed | Patients initiating BGF within 31-180 days of exacerbation Receives: Drug: BGF- BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL |
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
Measured: 180 days
Secondary outcomes (2)
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: 180 days
Annualized rate of all-cause mortality
Annualized incidence of all-cause mortality observed from index date (qualifying exacerbation event) through study completion (until end of data availability)
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start31 Oct 2025
- Primary completion28 Nov 2025
- Study completion28 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- 3,598 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Della Varghese, PhD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414134
- Sponsor's protocol ID
- D5980R00121
- Status last verified
- Feb 2026
- First submitted
- 28 Oct 2025
- Last updated
- 17 Feb 2026
- 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 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exacerbations and Real-World Outcomes Among Patients With Chronic Obstructive Pulmonary Disease Following Severe Exacerbation (MITOS:EROS+DISCHARGE)
- ClinicalTrials.gov ID
- NCT07414134
- Acronym / sponsor ID
- D5980R00121
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,598 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2025 (actual)
- Primary completion
- 28 Nov 2025 (actual)
- Study completion
- 28 Nov 2025 (actual)
- First posted
- 17 Feb 2026 (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.
This real-world retrospective study will use de-identified administrative claims data and will examine patients with a diagnosis of COPD who have experienced a qualifying severe disease exacerbation and received subsequent treatment with BGF. Agreed COPD patient data from the Inovalon MORE2 Registry® and Centers for Medicare \& Medicaid Services (CMS) 100% Medicare Fee for Service (FFS) database spanning from January 1, 2021 to the most recently available data (September 30th, 2024 for the MORE2 database, and December 31st, 2023 for the Medicare FFS database) will be used for this analysis. All patients will be required to present at least one prescription claim for BGF. Patients will also be required to show evidence of a qualifying severe COPD exacerbation event during the 180-day period preceding initiation of BGF. Index date will be set as the date of discharge from the qualifying severe exacerbation event.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prompt | – | Drug: BGF- BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROLPatients initiating BGF within 30-days of exacerbation |
| Delayed | – | Drug: BGF- BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROLPatients initiating BGF within 31-180 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 study population is selected to allow a clear comparison of outcomes according to the timing of BGF initiation following a severe COPD exacerbation. The overall sample will include adult (aged ≥40) patients with COPD who have experienced a qualifying severe COPD exacerbation and received treatment with BGF within 6 months. Patients should not have prior single inhaler triple therapy (SITT) use during the available history of patients' data preceding the qualifying index severe exacerbation and prior to initiating BGF treatment.
Key inclusion criteria (7 listed)
- ≥ 1 prescription(s) fill for BGF on or following January 1, 2021
- Patients must have evidence of a severe qualifying exacerbation event.
- ≥ 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 date
Key exclusion criteria (3 listed)
- Presence of cancer diagnoses other than basal or squamous cell skin cancer during the baseline period preceding the index date or entire follow-up period
- Presence of ≥2 claims with a diagnosis of interstitial fibrosis or sarcoidosis diagnoses during the period preceding the index date or entire follow-up period
- Presence of SITT at any time during the entire available history of patients' data preceding the index date 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 |
|---|---|---|
| BGF- BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROLThis is a real-world observational study evaluating the timing of BGF, post discharge. | Drug | Delayed, Prompt |
Primary outcome
Annualized COPD Exacerbation Event Rate
Time frame: 180 days
Annualized rates of COPD exacerbation events observed from index date (qualifying exacerbation event) through study completion (or until end of data availability
2 secondary outcomes
Annualized Cardiopulmonary Event Rate
Time frame: 180 days
Annualized rate of all-cause mortality
Time frame: 180 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 17 Feb 2026.
- 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.
Della Varghese, PhD 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 Chronic Obstructive Pulmonary Disease, 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 7 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 17 Feb 2026. 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: 180 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 17 Feb 2026.