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NCT06368427Not yet recruiting

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
AstraZenecaClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Chronic Obstructive Pulmonary Disease (COPD)
Drug/Device/Intervention
budesonide / glycopyrronium / formoterol
Study type
Observational
Intervention type
drug
Sponsor & location
Primary sponsor
AstraZeneca
Timeline & enrollment
Phase
N/A
Start date
Apr 30, 2024
End date
Sep 30, 2025
Enrollment
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 diseaseChronic obstructive pulmonary disease, unspecifiedOther specified chronic obstructive pulmonary diseaseChronic obstructive pulmonary disease with acute exacerbation, unspecifiedChronic obstructive pulmonary disease with acute lower respiratory infection
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06368427
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.