Outcomes in Real-life After Initation of Treatment With Trixeo (Budesonide / Glycopyrronium / Formoterol)
CHOROS ORION
1 other identifier
observational
250
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2023
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2023
CompletedFirst Posted
Study publicly available on registry
May 17, 2023
CompletedStudy Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2025
CompletedMarch 18, 2026
March 1, 2026
2 years
May 8, 2023
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
COPD Assessment Test (CAT) score
The change from baseline in COPD Assessment Test (CAT) score after 12 weeks treatment will be analysed using the within person difference between baseline and 12 weeks. Descriptive statistics (mean, median, standard deviation, interquartile range, minimum and maximum) will be provided. The mean change from baseline will be presented along with the 95% CI
baseline, 12 weeks after treatment start
Secondary Outcomes (12)
Baseline features
Baseline
Impact of COPD on patients' life based on CAT
baseline, 26 and 52 weeks
Patients' satisfaction to BGF
baseline, 26 and 52 weeks
Patient dyspnoea based on Modified Medical Research Council Dyspnoea Scale (mMRC)
Baseline, 26 and 52 weeks
Eosinophil count
baseline, 26 and 52 weeks
- +7 more secondary outcomes
Other Outcomes (4)
Relation between patient CAT score (dependent variable of interest) and patient baseline characteristics
52 weeks
Baseline variables associated with exacerbations
52 weeks
Occurrence of Major Cardiovascular Events (MACE)
52 weeks
- +1 more other outcomes
Study Arms (1)
COPD patients
Patients with COPD that start BGF treatment (The decision to prescribe BGF must be independent of enrolment into the study, must be determined by the treating physician and should be taken according to the standard of current best medical practice and national guideline)
Interventions
BGF is a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (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 decision to start treatment with BGF must be made by the treating physician according to the subjects' medical need and a positive benefit/risk balance. The decision to prescribe BGF must be independent of enrolment into the study, must be determined by the treating physician and should be taken according to the standard of current best medical practice and national guidelines.
Eligibility Criteria
The study population consists of adult patients with moderate to severe COPD who are eligible for BGF therapy, enrolled consecutively by physicians in specialist setting. The decision to start treatment with BGF must be made by the treating physician according to the subjects' medical need and a positive benefit/risk balance. The decision to prescribe BGF must be independent of enrolment into the study, must be determined by the treating physician and should be taken according to the standard of current best medical practice and national guidelines.
You may qualify if:
- Male or female, aged \>= 40;
- Physician-diagnosed COPD;
- Signed written informed and privacy consent prior to study participation;
- Patients starting treatment with BGF as prescribed according to the label, local market reimbursement criteria, and AIFA Nota 99;
- Patients must be able and willing to read and to comprehend written instructions, and to comprehend and complete the questionnaires required by the protocol.
You may not qualify if:
- COPD due to documented α-1 antitrypsin deficiency;
- Patients with controlled COPD treated with triple fixed-dose combination in 12 months prior to screening visits;
- Hospitalisation due to COPD exacerbation within the last 30 days prior to enrolment;
- Pregnancy or lactation period;
- Participation in a non-interventional observational trial that might, in the investigator's opinion, influence the assessment for the current study, or participation in any interventional, observational or clinical trial in the last 30 days prior to enrolment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (20)
Research Site
Acquaviva delle Fonti, Italy
Research Site
Alessandria, Italy
Research Site
Ancona, Italy
Research Site
Avellino, Italy
Research Site
Brescia, Italy
Research Site
Brindisi, Italy
Research Site
Busto Arsizio (Varese), Italy
Research Site
Catania, Italy
Research Site
Catanzaro, Italy
Research Site
Cittadella (Padova), Italy
Research Site
Florence, Italy
Research Site
Foggia, Italy
Research Site
Lecce, Italy
Research Site
Naples, Italy
Research Site
Passirana (Milano), Italy
Research Site
Pavia, Italy
Research Site
Roma, Italy
Research Site
Torino, Italy
Research Site
Treviso, Italy
Research Site
Verona, Italy
Related Publications (3)
Gaduzo S, McGovern V, Roberts J, Scullion JE, Singh D. When to use single-inhaler triple therapy in COPD: a practical approach for primary care health care professionals. Int J Chron Obstruct Pulmon Dis. 2019 Feb 13;14:391-401. doi: 10.2147/COPD.S173901. eCollection 2019.
PMID: 30863039BACKGROUNDBourbeau J, Bafadhel M, Barnes NC, Compton C, Di Boscio V, Lipson DA, Jones PW, Martin N, Weiss G, Halpin DMG. Benefit/Risk Profile of Single-Inhaler Triple Therapy in COPD. Int J Chron Obstruct Pulmon Dis. 2021 Mar 1;16:499-517. doi: 10.2147/COPD.S291967. eCollection 2021.
PMID: 33688176BACKGROUNDZheng Y, Zhu J, Liu Y, Lai W, Lin C, Qiu K, Wu J, Yao W. Triple therapy in the management of chronic obstructive pulmonary disease: systematic review and meta-analysis. BMJ. 2018 Nov 6;363:k4388. doi: 10.1136/bmj.k4388.
PMID: 30401700BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2023
First Posted
May 17, 2023
Study Start
June 1, 2023
Primary Completion
May 31, 2025
Study Completion
May 31, 2025
Last Updated
March 18, 2026
Record last verified: 2026-03