Pulmonary DiseaseNCT06514144
Exacerbations Among Patients Receiving Breztri (EROS Study)
An observational study of Pulmonary Disease and Chronic Obstructive, run by AstraZeneca at 1 site in United States.
Trial summary
EROS was a retrospective analysis of people with COPD using the MORE2 Registry®. Inclusion required ≥1 severe, ≥2 moderate, or ≥1 moderate exacerbation while on other maintenance treatment. Primary outcomes were the rate of COPD exacerbations and healthcare costs for those that received BGF promptly. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Retrospective Studies
- What is being tested?
- BGF
- How many people
- 2,409 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to 7 Mar 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: People with COPD who experienced a COPD exacerbation event and were subsequently initiated on therapy with budesonide/glycopyrrolate/formoterol fumarate (BGF); sourced from secondary administrative claims data between July 2020 through March 2022.
Who may be able to join
- ≥ 1 prescription fill for BGF on or following July 24th, 2020 (Breztri approval date);
- Evidence of any of the following exacerbation patterns within the 12-month period preceding the initiation of BGF, all index exacerbation events must occur following BGF approval: (1) one moderate exacerbation (the exacerbation must occur following approval of Breztri) with presence of other inhaled therapy, (2) two moderate exacerbations (the second exacerbation must occur following approval of Breztri) without the presence of other inhaled therapy, or (3) Severe Exacerbation- Inpatient COPD hospitalization
- ≥ 12 months of continuous enrollment preceding the index exacerbation date
- ≥ 90 days of continuous enrollment following the index exacerbation date
- Age ≥ 40 years on the index exacerbation date
Who cannot join
- Presence of closed triple therapy during the baseline period
- Initiation of BGF 4/1/2022 or later
- Presence of an enrollment gap of more than 14-days from index exacerbation date to BGF initiation date
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exacerbations and Real-World Outcomes Among Chronic Obstructive Pulmonary Disease Patients Receiving Breztri (EROS Study)
EROS was a retrospective analysis of people with COPD using the MORE2 Registry®. Inclusion required ≥1 severe, ≥2 moderate, or ≥1 moderate exacerbation while on other maintenance treatment. Primary outcomes were the rate of COPD exacerbations and healthcare costs for those that received BGF promptly. The effect of each 30-day delay in initiation of BGF was estimated using a multivariable negative binomial regression model.
Read the detailed description
EROS was a retrospective real-world evidence claims analysis study, assessing the relationship between the timing of Breztri Aerosphere following an exacerbation and the appearance of subsequent disease exacerbations of people with COPD.
The study used administrative claims data in the US sourced from the Inovalon MORE2 Registry® between July 2019 and March 2022. Inclusion required one of the following qualifying exacerbation events: ≥1 severe, ≥2 moderate, or ≥1 moderate exacerbation while on other maintenance treatment, be age ≥40 at the index date, and have ≥90 days of continuous enrollment following the index date.
Primary outcomes were the rate of COPD exacerbations and healthcare costs for those that received BGF promptly. The effect of each 30-day delay in initiation of BGF was estimated using a multivariable negative binomial regression model. Statistical analyses included both descriptive and multivariable approaches- negative binomial regression models to estimate the effect of each 30-day delay on the number of exacerbations and a gamma model with a log-link to estimate the effects on the incremental increase in COPD-related costs.
- Being tested
- BGF
- Keywords
- COPD, Delayed therapy, Exacerbations, Triple therapy
- Medical subject headings
- Lung Diseases, 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/glycopyrrolate/formoterol fumarate
| Study group | Role | What they receive |
|---|---|---|
| Treatment Initiation | Initiation of treatment following exacerbation classified as prompt, delayed or very delayed. Receives: Drug: BGF |
What is being measured
The primary outcome is the main question the study is designed to answer.
COPD Exacerbation events
Annualized rates of COPD exacerbation events observed from index date (qualifying exacerbation event) through study completion (until end of data availability), an average follow-up time of 331 days.
Measured: Annualized rates from index exacerbation through end of data availability, an average follow-up time of 331 days.
Secondary outcomes (2)
Healthcare resource utilization
Annualized rates of health care services observed (e.g., inpatient visits, ER visits) from index date (qualifying exacerbation event) through study completion (until end of data availability), an average follow-up time of 331 days.
Measured: Annualized rates from index exacerbation through end of data availability, an average follow-up time of 331 days.
Healthcare costs
Annualized costs of health care services observed (e.g., total health care costs, total-COPD related costs) from index date (qualifying exacerbation event) through study completion (until end of data availability), an average follow-up time of 331 days.
Measured: Annualized costs from idex exacerbation through end of data availability, an average follow-up time of 331 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 Oct 2022
- Primary completion7 Mar 2023
- Study completion7 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 2,409 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
- NCT06514144
- Sponsor's protocol ID
- D5980R00079
- Status last verified
- Dec 2024
- First submitted
- 18 Mar 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exacerbations and Real-World Outcomes Among Chronic Obstructive Pulmonary Disease Patients Receiving Breztri (EROS Study)
- ClinicalTrials.gov ID
- NCT06514144
- Acronym / sponsor ID
- D5980R00079
- Keywords
- COPD, Delayed therapy, Exacerbations, Triple therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,409 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 7 Mar 2023 (actual)
- Study completion
- 7 Mar 2023 (actual)
- First posted
- 23 Jul 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.
EROS was a retrospective analysis of people with COPD using the MORE2 Registry®. Inclusion required ≥1 severe, ≥2 moderate, or ≥1 moderate exacerbation while on other maintenance treatment. Primary outcomes were the rate of COPD exacerbations and healthcare costs for those that received BGF promptly. The effect of each 30-day delay in initiation of BGF was estimated using a multivariable negative binomial regression model.
Detailed description
EROS was a retrospective real-world evidence claims analysis study, assessing the relationship between the timing of Breztri Aerosphere following an exacerbation and the appearance of subsequent disease exacerbations of people with COPD.
The study used administrative claims data in the US sourced from the Inovalon MORE2 Registry® between July 2019 and March 2022. Inclusion required one of the following qualifying exacerbation events: ≥1 severe, ≥2 moderate, or ≥1 moderate exacerbation while on other maintenance treatment, be age ≥40 at the index date, and have ≥90 days of continuous enrollment following the index date.
Primary outcomes were the rate of COPD exacerbations and healthcare costs for those that received BGF promptly. The effect of each 30-day delay in initiation of BGF was estimated using a multivariable negative binomial regression model. Statistical analyses included both descriptive and multivariable approaches- negative binomial regression models to estimate the effect of each 30-day delay on the number of exacerbations and a gamma model with a log-link to estimate the effects on the incremental increase in COPD-related costs.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Initiation | – | Drug: BGFInitiation of treatment following exacerbation classified as prompt, delayed or very delayed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People with COPD who experienced a COPD exacerbation event and were subsequently initiated on therapy with budesonide/glycopyrrolate/formoterol fumarate (BGF); sourced from secondary administrative claims data between July 2020 through March 2022.
Key inclusion criteria (5 listed)
- ≥ 1 prescription fill for BGF on or following July 24th, 2020 (Breztri approval date);
- Evidence of any of the following exacerbation patterns within the 12-month period preceding the initiation of BGF, all index exacerbation events must occur following BGF approval: (1) one moderate exacerbation (the exacerbation must occur following approval of Breztri) with presence of other inhaled therapy, (2) two moderate exacerbations (the second exacerbation must occur following approval of Breztri) without the presence of other inhaled therapy, or (3) Severe Exacerbation- Inpatient COPD hospitalization
- ≥ 12 months of continuous enrollment preceding the index exacerbation date
- ≥ 90 days of continuous enrollment following the index exacerbation date
- Age ≥ 40 years on the index exacerbation date
Key exclusion criteria (3 listed)
- Presence of closed triple therapy during the baseline period
- Initiation of BGF 4/1/2022 or later
- Presence of an enrollment gap of more than 14-days from index exacerbation date to BGF initiation date
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/glycopyrrolate/formoterol fumarate | Drug | Treatment Initiation |
Primary outcome
COPD Exacerbation events
Time frame: Annualized rates from index exacerbation through end of data availability, an average follow-up time of 331 days.
Annualized rates of COPD exacerbation events observed from index date (qualifying exacerbation event) through study completion (until end of data availability), an average follow-up time of 331 days.
2 secondary outcomes
Healthcare resource utilization
Time frame: Annualized rates from index exacerbation through end of data availability, an average follow-up time of 331 days.
Healthcare costs
Time frame: Annualized costs from idex exacerbation through end of data availability, an average follow-up time of 331 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 13 Dec 2024.
- 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 and 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 13 Dec 2024. 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?
COPD Exacerbation events (time frame: Annualized rates from index exacerbation through end of data availability, an average follow-up time of 331 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 13 Dec 2024.