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Change in Patient-repOrted Outcomes in COPD Patients Newly Initiated on TRIXEO AEROSPHERE in Real worlD - Trial NCT06368427

Access comprehensive clinical trial information for NCT06368427 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 250 participants.

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NCT06368427
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Trial Details
ClinicalTrials.gov โ€ข NCT06368427
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Change in Patient-repOrted Outcomes in COPD Patients Newly Initiated on TRIXEO AEROSPHERE in Real worlD
A Non-interventional, Multi-centre Study to Investigate the Change in Patient-reported Outcomes in Moderate to Severe COPD Patients Newly Initiated on TRIXEO AEROSPHERE (Budesonide/Glycopyrronium/Formoterol) in Real-life Setting in Romania

Study Focus

budesonide / glycopyrronium / formoterol

Observational

drug

Sponsor & Location

AstraZeneca

Timeline & Enrollment

N/A

Apr 30, 2024

Sep 30, 2025

250 participants

Primary Outcome

Change from baseline to 12 weeks (3 months) in the COPD Assessment Test (CAT) score

Summary

The purpose of this study is to describe patients' clinical and self-reported outcomes of
 treatment with budesonide / glycopyrronium / formoterol Metered dose inhaler (BGF MDI) in
 Romania in real-life setting, up to 6 month of observation period. The study will focus
 primarily on the change in self-perceived health status in the first 12 weeks (3 months) of
 treatment with no pre-defined hypothesis.

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

NCT06368427

Non-Device Trial