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

NCT06321731

CompletedN/A

Sponsor: AstraZeneca

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Countries: 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.

Eligibility overview

Sex: ALL

Age: 40 Years to 130 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria:

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.

Exclusion Criteria:

1. Subjects with BGF treatment not intended for COPD (e.g., intended for asthma).
2. Subject participated in a clinical trial during the study data observation period.
Locations (15)
  • Barcelona, Spain
  • Granada, Spain
  • Lleida, Spain
  • Lugo, Spain
  • Madrid, Spain
  • Málaga, Spain
  • Murcia, Spain
  • Ourense, Spain
  • Oviedo, Spain
  • Palma de Mallorca, Spain
  • Santa Cruz de Tenerife, Spain
  • Seville, Spain
  • Valencia, Spain
  • Vitoria-Gasteiz, Spain
  • Zaragoza, Spain