Viewing Study NCT06422676



Ignite Creation Date: 2024-06-16 @ 11:48 AM
Last Modification Date: 2024-10-26 @ 3:30 PM
Study NCT ID: NCT06422676
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2024-07-05
First Post: 2024-02-29

Brief Title: MultIceNtre Non-intERVentional Study for EfficacySafety Evaluation of BREZTRI in Pts With COPD in RussiA
Sponsor: AstraZeneca
Organization: AstraZeneca

Study Overview

Official Title: Open-label Single-arm Non-interventional Multi-centre Cohort Study for Evaluation of Clinical and Patient Reported Outcomes in New Users of BREZTRI Budesonide Glycopyrronium Formoterol in Routine Care Settings
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: MINERVA
Brief Summary: This is a retrospective-prospective non-interventional multi-centre study that will be conducted in routine clinical settings in Russia Eligible patients with moderate to severe COPD routinely treated with BREZTRI will be observed according to routine clinical practice for up to 24 weeks
Detailed Description: Chronic obstructive pulmonary disease COPD is a disease characterized by persistent airflow limitation that is usually progresses and is a consequence of a chronic inflammatory response of the respiratory pathways and lung tissue to the effects of inhaled harmful particles or gases Exacerbations and comorbid conditions are an integral part of the disease and contribute significantly to the clinical picture and prognosis 1

Patient-reported outcomes both symptom-based and health-related quality of life-specific are essential to evaluate symptoms impact of symptoms on activities of daily living and treatment response in COPD patients 12

There is a need to evaluate the patient-reported outcomes during a triple therapy with budesonide glycopyrronium bromide formoterol Breztri in a real-life clinical practice The aim of the study is to evaluate clinical and patient-reported outcomes of treatment with BREZTRI through effectiveness measures assessed pre- and post-treatment initiation and safety monitoring The study results will be interpreted in the context of an open label single arm study design where multiple factors in addition to the new treatment may contribute to the treatment effect

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None