Chronic Obstructive Pulmonary Disease (COPD)ORESTESNCT06321731
Real-World Outcomes in COPD Patients Starting Trixeo (Budesonide/Glycopyrronium/Formoterol) in Spain.
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 15 sites in Spain.
Trial summary
The aim of the ORESTES study is to describe the characteristics of the COPD patients initiating Trixeo (BGF -budesonide/glycopyrronium/formoterol) in Spain and to assess their real-world outcomes up to 12 months afterwards. Read more about this study
- Who is it for?
- Ages 40 to 130 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- How many people
- 718 participants
- Where
- 15 sitesSpain
- Study dates
- 2 Jul 2024to 16 Dec 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 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include 500-700 COPD patients who started BGF treatment at least 12 months before start of data collection, and from approximately 20 hospitals in Spain.
Who may be able to join
- 1 .Patient diagnosed with COPD confirmed by spirometry (postbronchodilator FEV1/FVC<0.7).
- 2. Patients treated with BGF initiated at least 12 months before start of data collection.
- 3. Patients with information available at least 12 months before BGF initiation.
- 4. Adult patients aged ≥40 years old at index date.
Who cannot join
- Subjects with BGF treatment not intended for COPD (e.g., intended for asthma).
- Subject participated in a clinical trial during the study data observation period.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Spain15 sites
Research Site
Barcelona
Research Site
Granada
Research Site
Lleida
Research Site
Lugo
Research Site
Madrid
Research Site
Málaga
Research Site
Murcia
Research Site
Ourense
Research Site
Oviedo
Research Site
Palma de Mallorca
Research Site
Santa Cruz de Tenerife
Research Site
Seville
Research Site
Valencia
Research Site
Vitoria-Gasteiz
Research Site
Zaragoza
About this study
Official title: Observational Retrospective Study To Describe Characteristics And Evaluate Real-World Outcomes in COPD Patients Initiating Trixeo Aerosphere (Budesonide/Glycopyrronium Bromide/Formoterol Fumarate) in Spain
The aim of the ORESTES study is to describe the characteristics of the COPD patients initiating Trixeo (BGF -budesonide/glycopyrronium/formoterol) in Spain and to assess their real-world outcomes up to 12 months afterwards.
For that purpose,a descriptive, observational, multi-centre, longitudinal, retrospective cohort study involving ~20 Spanish centres and aiming to include between 500 and 700 patients, has been designed.
Read the detailed description
Chronic Obstructive Pulmonary Disease (COPD) is characterized by irreversible airflow obstruction, and it is a significant global health concern. According to the World Health Organization (WHO) COPD is the third leading cause of death worldwide, causing 3.23 million deaths in 2019. In Spain, around 12% of the population over 40 (approximately 2.2 million people) suffer from COPD, with an 11% mortality rate following hospitalization for a COPD exacerbation.
COPD exacerbations, associated with reduced quality of life, increased healthcare utilization, and substantial mortality, are more likely to recur in patients who have experienced one moderate or severe exacerbation. Traditionally, long-term bronchodilator therapy has been the primary pharmaceutical approach, including β2 agonists, anticholinergics, and inhaled corticosteroids (ICS). Triple therapy (TT), combining a long-acting β2 agonist (LABA), long-acting anticholinergic (LAMA), and ICS, is recommended for patients with persistent exacerbations.
Trixeo Aerosphere®, a fixed-dose combination of ICS/LABA/LAMA (budesonide/glycopyrronium bromide/formoterol fumarate, hereafter BGF) in a single inhaler, was approved in the European Union in December 2020 and marketed in Spain from February 2022. The Phase III ETHOS trial demonstrated significant reductions in moderate to severe exacerbations, improved quality of life, and lung function compared to dual therapies.
To assess real-world outcomes of patients initiating BGF in Spain, the ORESTES study has been designed.
The study primary objective is to describe the occurrence and severity of exacerbations of COPD-diagnosed patients receiving BGF from treatment initiation to end of treatment, loss to follow-up, death or up to 12 months of treatment.
The study secondary objectives are:
- To describe the demographic and clinical profile of patients at the moment of BGF initiation.
- To describe other patients' clinical outcomes (apart from exacerbations), treatment outcomes and healthcare resource utilisation (HCRU) after initiation of BGF.
The study exploratory objectives are:
- To describe severe cardiovascular (CV)-related outcomes after initiation of BGF.
- To describe the mortality after initiation of BGF.
Descriptive, observational multi-centre, longitudinal, retrospective cohort study aiming to include adult patients aged 40 years or older diagnosed with COPD and who initiated BGF at least 12 months before inclusion.
The study observation period runs from 12 months prior to the start of BGF, defined as the index date, until the censoring date, i.e., the earliest of BGF treatment discontinuation, loss to follow-up, death or maximum of 12 months after index date.
This study is based exclusively on secondary data collection from outpatient electronic medical records (EMRs). Therefore, it will rely on already existing data from patients by the time of data collection.
The study will include 500-700 patients from approximately 20 hospitals in Spain.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| COPD patients initiating BGF | COPD patients ≥40 years old initiating BGF (budesonide/glycopyrronium bromide/formoterol fumarate) at least 12 months before start of data collection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized rate of exacerbations after BGF initiation
Annualized rate (total number of exacerbations divided by the total number of person years) of exacerbations occurred during the study data observation period after BGF initiation, overall and classified by severity (severe and moderate).
Measured: Up to 12 months
Secondary outcomes (7)
Demographic and clinical profile of patients initiating BGF.
Patient demographics, comorbidities, clinical characteristics related to COPD and other respiratory-related variables such as lung function and dyspnoea, the presence of eosinophils, exacerbations, medication used for COPD, including OCS and rescue medication, and the healthcare resource use (HCRU).
Measured: Index date (BGF initiation) and baseline (previous 12 months)
Lung Function after BGF initiation
Measured by forced expiratory volume at first second (FEV1), FEV1 of the predicted %, forced vital capacity (FVC) volume and % FEV1/FVC
Measured: Up to 12 months
Eosinophils count after BGF initiation
Counts in cells/µL
Measured: Up to 12 months
Persistence to treatment (BGF)
Duration time from initiation to discontinuation of treatment
Measured: Up to 12 months
Need for rescue medication after BGF initiation
Number of uses per year and time to first use
Measured: Up to 12 months
Use of oral corticosteroids (OCS) after BGF initiation
Frequency and cumulative dosage (mg)
Measured: Up to 12 months
HCRUs related to COPD after BGF initiation
Annualized rate of specialist visits, general practitioner (GP) visits, ER admissions and hospitalizations (along with duration)
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start2 Jul 2024
- Primary completion16 Dec 2024
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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
- 718 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06321731
- Sponsor's protocol ID
- D5980R00096
- Acronym
- ORESTES
- Status last verified
- Nov 2025
- First submitted
- 6 Mar 2024
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Figueira-Goncalves JM, Alcazar-Navarrete B, Ancochea A, Lastres T, de Andres-Nogales F, Corregidor-Garcia C, Fitas E, Sanchez-Covisa J. Impact of Budesonide/Glycopyrronium/Formoterol Initiation on Healthcare Resource Utilization and Estimated Associated Costs and Greenhouse Gas Emissions Across COPD Care in Spain (ORESTES* Study). Adv Ther. 2026 Oct 21. doi: 10.1007/s12325-026-03817-8. Online ahead of print.
PubMed 42907700Alcazar-Navarrete B, Figueira-Goncalves JM, Blanco Cid N, Bruguera Avila N, Bernabeu Mora R, Fuster Gomila A, Galera Martinez R, Garcia Clemente MM, Granados G, Khadour Khadour H, Marquez-Martin E, Murga Arizabaleta I, Velasco Garrido JL, Corregidor-Garcia C, Fitas E, Sanchez-Covisa J. Real-World Outcomes across Baseline Risk Profiles in Patients with COPD Initiating Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate in Spain: Insights from the ORESTES Study. Pulm Ther. 2026 Jun;12(2):667-689. doi: 10.1007/s41030-026-00366-x. Epub 2026 Jun 2.
PubMed 42228247Figueira-Goncalves JM, Alcazar-Navarrete B, Casitas-Mateo R, Gonzalez J, Gotera-Rivera CM, Herrejon-Silvestre A, Margallo-Iribarnegaray J, Martin-Lana M, Pallares-Sanmartin A, Pascual-Guardia S, Saura-Vinuesa A, Corregidor-Garcia C, Fitas E, Sanchez-Covisa J. Real-World Outcomes in Patients with COPD Initiating Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate After Dual and Triple Therapy in Spain: A Sub-Study of the ORESTES Study. Pulm Ther. 2026 Mar;12(1):329-349. doi: 10.1007/s41030-026-00341-6. Epub 2026 Jan 19.
PubMed 41553424Alcazar-Navarrete B, Figueira-Goncalves JM, Corregidor-Garcia C, Fitas E, Sanchez-Covisa J; ORESTES group. Real-World Outcomes in Patients with COPD Initiating Budesonide/Glycopyrronium/Formoterol Fumarate Dehydrate in Spain: ORESTES Study. Adv Ther. 2025 Nov;42(11):5708-5726. doi: 10.1007/s12325-025-03361-x. Epub 2025 Sep 22.
PubMed 40982160
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Retrospective Study To Describe Characteristics And Evaluate Real-World Outcomes in COPD Patients Initiating Trixeo Aerosphere (Budesonide/Glycopyrronium Bromide/Formoterol Fumarate) in Spain
- ClinicalTrials.gov ID
- NCT06321731
- Acronym / sponsor ID
- ORESTES / D5980R00096
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 718 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 20 Mar 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.
The aim of the ORESTES study is to describe the characteristics of the COPD patients initiating Trixeo (BGF -budesonide/glycopyrronium/formoterol) in Spain and to assess their real-world outcomes up to 12 months afterwards.
For that purpose,a descriptive, observational, multi-centre, longitudinal, retrospective cohort study involving ~20 Spanish centres and aiming to include between 500 and 700 patients, has been designed.
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) is characterized by irreversible airflow obstruction, and it is a significant global health concern. According to the World Health Organization (WHO) COPD is the third leading cause of death worldwide, causing 3.23 million deaths in 2019. In Spain, around 12% of the population over 40 (approximately 2.2 million people) suffer from COPD, with an 11% mortality rate following hospitalization for a COPD exacerbation.
COPD exacerbations, associated with reduced quality of life, increased healthcare utilization, and substantial mortality, are more likely to recur in patients who have experienced one moderate or severe exacerbation. Traditionally, long-term bronchodilator therapy has been the primary pharmaceutical approach, including β2 agonists, anticholinergics, and inhaled corticosteroids (ICS). Triple therapy (TT), combining a long-acting β2 agonist (LABA), long-acting anticholinergic (LAMA), and ICS, is recommended for patients with persistent exacerbations.
Trixeo Aerosphere®, a fixed-dose combination of ICS/LABA/LAMA (budesonide/glycopyrronium bromide/formoterol fumarate, hereafter BGF) in a single inhaler, was approved in the European Union in December 2020 and marketed in Spain from February 2022. The Phase III ETHOS trial demonstrated significant reductions in moderate to severe exacerbations, improved quality of life, and lung function compared to dual therapies.
To assess real-world outcomes of patients initiating BGF in Spain, the ORESTES study has been designed.
The study primary objective is to describe the occurrence and severity of exacerbations of COPD-diagnosed patients receiving BGF from treatment initiation to end of treatment, loss to follow-up, death or up to 12 months of treatment.
The study secondary objectives are:
- To describe the demographic and clinical profile of patients at the moment of BGF initiation.
- To describe other patients' clinical outcomes (apart from exacerbations), treatment outcomes and healthcare resource utilisation (HCRU) after initiation of BGF.
The study exploratory objectives are:
- To describe severe cardiovascular (CV)-related outcomes after initiation of BGF.
- To describe the mortality after initiation of BGF.
Descriptive, observational multi-centre, longitudinal, retrospective cohort study aiming to include adult patients aged 40 years or older diagnosed with COPD and who initiated BGF at least 12 months before inclusion.
The study observation period runs from 12 months prior to the start of BGF, defined as the index date, until the censoring date, i.e., the earliest of BGF treatment discontinuation, loss to follow-up, death or maximum of 12 months after index date.
This study is based exclusively on secondary data collection from outpatient electronic medical records (EMRs). Therefore, it will rely on already existing data from patients by the time of data collection.
The study will include 500-700 patients from approximately 20 hospitals in Spain.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD patients initiating BGF | – | –COPD patients ≥40 years old initiating BGF (budesonide/glycopyrronium bromide/formoterol fumarate) at least 12 months before start of data collection. |
Who may qualify
- Ages
- 40 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include 500-700 COPD patients who started BGF treatment at least 12 months before start of data collection, and from approximately 20 hospitals in Spain.
Key inclusion criteria (4 listed)
- 1 .Patient diagnosed with COPD confirmed by spirometry (postbronchodilator FEV1/FVC<0.7).
- 2. Patients treated with BGF initiated at least 12 months before start of data collection.
- 3. Patients with information available at least 12 months before BGF initiation.
- 4. Adult patients aged ≥40 years old at index date.
Key exclusion criteria (2 listed)
- Subjects with BGF treatment not intended for COPD (e.g., intended for asthma).
- Subject participated in a clinical trial during the study data observation period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Annualized rate of exacerbations after BGF initiation
Time frame: Up to 12 months
Annualized rate (total number of exacerbations divided by the total number of person years) of exacerbations occurred during the study data observation period after BGF initiation, overall and classified by severity (severe and moderate).
7 secondary outcomes
Demographic and clinical profile of patients initiating BGF.
Time frame: Index date (BGF initiation) and baseline (previous 12 months)
Lung Function after BGF initiation
Time frame: Up to 12 months
Eosinophils count after BGF initiation
Time frame: Up to 12 months
Persistence to treatment (BGF)
Time frame: Up to 12 months
Need for rescue medication after BGF initiation
Time frame: Up to 12 months
Use of oral corticosteroids (OCS) after BGF initiation
Time frame: Up to 12 months
HCRUs related to COPD after BGF initiation
Time frame: Up to 12 months
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 28 Nov 2025.
- Derived from this study: PubMed 42907700Figueira-Goncalves JM, Alcazar-Navarrete B, Ancochea A, Lastres T, de Andres-Nogales F, Corregidor-Garcia C, Fitas E, Sanchez-Covisa J. Impact of Budesonide/Glycopyrronium/Formoterol Initiation on Healthcare Resource Utilization and Estimated Associated Costs and Greenhouse Gas Emissions Across COPD Care in Spain (ORESTES* Study). Adv Ther. 2026 Oct 21. doi: 10.1007/s12325-026-03817-8. Online ahead of print.
- Derived from this study: PubMed 42228247Alcazar-Navarrete B, Figueira-Goncalves JM, Blanco Cid N, Bruguera Avila N, Bernabeu Mora R, Fuster Gomila A, Galera Martinez R, Garcia Clemente MM, Granados G, Khadour Khadour H, Marquez-Martin E, Murga Arizabaleta I, Velasco Garrido JL, Corregidor-Garcia C, Fitas E, Sanchez-Covisa J. Real-World Outcomes across Baseline Risk Profiles in Patients with COPD Initiating Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate in Spain: Insights from the ORESTES Study. Pulm Ther. 2026 Jun;12(2):667-689. doi: 10.1007/s41030-026-00366-x. Epub 2026 Jun 2.
- Derived from this study: PubMed 41553424Figueira-Goncalves JM, Alcazar-Navarrete B, Casitas-Mateo R, Gonzalez J, Gotera-Rivera CM, Herrejon-Silvestre A, Margallo-Iribarnegaray J, Martin-Lana M, Pallares-Sanmartin A, Pascual-Guardia S, Saura-Vinuesa A, Corregidor-Garcia C, Fitas E, Sanchez-Covisa J. Real-World Outcomes in Patients with COPD Initiating Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate After Dual and Triple Therapy in Spain: A Sub-Study of the ORESTES Study. Pulm Ther. 2026 Mar;12(1):329-349. doi: 10.1007/s41030-026-00341-6. Epub 2026 Jan 19.
- Derived from this study: PubMed 40982160Alcazar-Navarrete B, Figueira-Goncalves JM, Corregidor-Garcia C, Fitas E, Sanchez-Covisa J; ORESTES group. Real-World Outcomes in Patients with COPD Initiating Budesonide/Glycopyrronium/Formoterol Fumarate Dehydrate in Spain: ORESTES Study. Adv Ther. 2025 Nov;42(11):5708-5726. doi: 10.1007/s12325-025-03361-x. Epub 2025 Sep 22.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites 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 (COPD), run by AstraZeneca at 15 sites in Spain.
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 4 inclusion and 2 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 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Spain. 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 rate of exacerbations after BGF initiation (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06321731, which also lists 4 linked publications.
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 28 Nov 2025.