Outcomes in Real-life After Initation of Treatment With Trixeo (Budesonide / Glycopyrronium / For… (NCT05862545) | Clinical Trial Compass
CompletedNot Applicable
Outcomes in Real-life After Initation of Treatment With Trixeo (Budesonide / Glycopyrronium / Formoterol)
Italy250 participantsStarted 2023-06-01
Plain-language 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.
Who can participate
Age range
40 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. COPD due to documented α-1 antitrypsin deficiency;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
COPD Assessment Test (CAT) score
Timeframe: baseline, 12 weeks after treatment start
. 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.