Real-World Outcomes in COPD Patients Starting Trixeo (Budesonide/Glycopyrronium/Formoterol) in Spain.

NCT06321731 | Completed

• 1 other identifier: D5980R00096
• Study Type: observational
• Target: 718
• Locations: 1 country
• Sites: 15

Brief 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. 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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

• 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).

  Up to 12 months

Secondary Outcomes (7)

• Demographic and clinical profile of patients initiating BGF.

  Index date (BGF initiation) and baseline (previous 12 months)

• Lung Function after BGF initiation

  Up to 12 months

• Eosinophils count after BGF initiation

  Up to 12 months

• Persistence to treatment (BGF)

  Up to 12 months

• Need for rescue medication after BGF initiation

  Up to 12 months

Other Outcomes (2)

• Annualized rate of severe cardiovascular (CV)-related outcomes after initiation of BGF.

  Up to 12 months

• Mortality (% and time to event) after BGF initiation

  Up to 12 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 40 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Patient diagnosed with COPD confirmed by spirometry (postbronchodilator FEV1/FVC\<0.7).
• \. Patients treated with BGF initiated at least 12 months before start of data collection.
• \. Patients with information available at least 12 months before BGF initiation.
• \. Adult patients aged ≥40 years old at index date.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (15)

Research Site

Barcelona, Spain

Location

Research Site

Granada, Spain

Location

Research Site

Lleida, Spain

Location

Research Site

Lugo, Spain

Location

Research Site

Madrid, Spain

Location

Research Site

Málaga, Spain

Location

Research Site

Murcia, Spain

Location

Research Site

Ourense, Spain

Location

Research Site

Oviedo, Spain

Location

Research Site

Palma de Mallorca, Spain

Location

Research Site

Santa Cruz de Tenerife, Spain

Location

Research Site

Seville, Spain

Location

Research Site

Valencia, Spain

Location

Research Site

Vitoria-Gasteiz, Spain

Location

Research Site

Zaragoza, Spain

Location

Related Publications (2)

• Figueira-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 Jan 19. doi: 10.1007/s41030-026-00341-6. Online ahead of print.

  PMID: 41553424 DERIVED

• Alcazar-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.

  PMID: 40982160 DERIVED

Related Links

• Redacted CSR Synopsis

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 20, 2024
• Study Start: July 2, 2024
• Primary Completion: December 16, 2024
• Study Completion: December 16, 2024
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

ES (15)