Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05862545
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2023-05-08
Brief Title:
Outcomes in Real-life After Initation of Treatment With Trixeo Budesonide Glycopyrronium Formoterol
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
Outcomes in Real-life After Initation Of treatmeNt With Trixeo Budesonide Glycopyrronium Formoterol a Non-interventional Multi-centre Prospective Cohort Study in Italian Routine Care Setting
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
CHOROS ORION
Brief Summary:
The aim of the CHOROS ORION study is to describe patients clinical and self-reported outcomes of treatment with BGF in Italy through effectiveness clinical and self-reported measures assessed pre- and post-treatment initiation up to one year of observation period The study will focus primarily on the change in self-perceived health status in the first 12 weeks of treatment This will allow to assess the short-term impact of treatment thus contributing to fill the gap of knowledge from the current available medical literature Moreover in order to provide also a broader view patients will be followed up to 52 weeks where possible The study results will be interpreted in the context of an observational study design where multiple factors in addition to the new treatment may contribute to the treatment effect
Detailed Description:
The therapeutic goal of chronic obstructive pulmonary disease COPD management is mainly reduction of symptoms and severity of exacerbationsTriple therapy the combination of an ICS a LABA and a LAMA in a single fixed-dose combination is a valuable development in the treatment of COPD On top of treatment adherence enhancement Gaduzo et al 2019 trials showed triple therapy improving lung function Patients-Reported Outcomes PROs health-related quality of life as well as lowering exacerbations and hospitalization rate compared to dual or mono-therapy Bourbeau et al 2021 Zheng et al 2018
Budesonideglycopyrrolateformoterol fumarate hereafter BGF is a maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an ICS and a LABA or a combination of a LABA and a LAMA The availability of single-inhaler triple therapies in routine care may improve symptoms control reduce exacerbation rate and COPD-related healthcare costs thus leading to an improvement in patient health status and quality of life However real-world studies focusing on PROs are still limited
The aim of the CHOROS ORION study is to describe patients clinical and self-reported outcomes of treatment with BGF in Italy through effectiveness clinical and self-reported measures assessed pre- and post-treatment initiation up to one year of observation period The study will focus primarily on the change in self-perceived health status in the first 12 weeks of treatment This will allow to assess the short-term impact of treatment thus contributing to fill the gap of knowledge from the current available medical literature Moreover in order to provide also a broader view patients will be followed up to 52 weeks where possible The study results will be interpreted in the context of an observational study design where multiple factors in addition to the new treatment may contribute to the treatment effect
Budesonideglycopyrrolateformoterol fumarate hereafter BGF is a maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an ICS and a LABA or a combination of a LABA and a LAMA The availability of single-inhaler triple therapies in routine care may improve symptoms control reduce exacerbation rate and COPD-related healthcare costs thus leading to an improvement in patient health status and quality of life However real-world studies focusing on PROs are still limited
The aim of the CHOROS ORION study is to describe patients clinical and self-reported outcomes of treatment with BGF in Italy through effectiveness clinical and self-reported measures assessed pre- and post-treatment initiation up to one year of observation period The study will focus primarily on the change in self-perceived health status in the first 12 weeks of treatment This will allow to assess the short-term impact of treatment thus contributing to fill the gap of knowledge from the current available medical literature Moreover in order to provide also a broader view patients will be followed up to 52 weeks where possible The study results will be interpreted in the context of an observational 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?:
True
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