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Real-World Outcomes in COPD Patients Starting Trixeo (Budesonide/Glycopyrronium/Formoterol) in Spain. - Trial NCT06321731

Access comprehensive clinical trial information for NCT06321731 through Pure Global AI's free database. This phase not specified trial is sponsored by AstraZeneca and is currently Not yet recruiting. The study focuses on Chronic Obstructive Pulmonary Disease (COPD). Target enrollment is 500 participants.

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NCT06321731
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Trial Details
ClinicalTrials.gov โ€ข NCT06321731
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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

Study Focus

Observational

Sponsor & Location

AstraZeneca

Timeline & Enrollment

N/A

Jun 10, 2024

Nov 30, 2024

500 participants

Primary Outcome

Annualized rate of exacerbations after BGF initiation

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.

ICD-10 Classifications

Other chronic obstructive pulmonary disease
Chronic obstructive pulmonary disease, unspecified
Other specified chronic obstructive pulmonary disease
Chronic obstructive pulmonary disease with acute exacerbation, unspecified
Chronic obstructive pulmonary disease with acute lower respiratory infection

Data Source

ClinicalTrials.gov

NCT06321731

Non-Device Trial