NCT06321731Completed
Real-World Outcomes in COPD Patients Starting Trixeo (Budesonide/Glycopyrronium/Formoterol) in Spain.
Observational Retrospective Study To Describe Characteristics And Evaluate Real-World Outcomes in COPD Patients Initiating Trixeo Aerosphere (Budesonide/Glycopyrronium Bromide/Formoterol Fumarate) in Spain
Source: ClinicalTrials.gov · Last updated 28 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 718 (actual)
- First submitted
- 6 Mar 2024
- Start date
- 2 Jul 2024
- Primary completion date
- 16 Dec 2024
- Lead sponsor
- AstraZeneca
- Diseases
- COPD
- NCT number
- NCT06321731
What you commit to
- Study type: Observational
- Participants enrolled: 718
- From 2 Jul 2024 to the primary completion date, 16 Dec 2024
- 15 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 40 years to 130 years · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Save your city in your profile to sort them by distance.
Related publications
- 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 · PMID 42907700
- 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 · PMID 42228247
- 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 · PMID 41553424
This page is information, not medical advice. Discuss any trial with your doctor.