NCT05862545Completed
Outcomes in Real-life After Initation of Treatment With Trixeo (Budesonide / Glycopyrronium / Formoterol)
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
Source: ClinicalTrials.gov · Last updated 18 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 250 (actual)
- First submitted
- 8 May 2023
- Start date
- 1 Jun 2023
- Primary completion date
- 31 May 2025
- Lead sponsor
- AstraZeneca
- Diseases
- COPD
- NCT number
- NCT05862545
What you commit to
- Study type: Observational
- Participants enrolled: 250
- From 1 Jun 2023 to the primary completion date, 31 May 2025
- 20 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
- 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.
Other
- COPD due to documented α-1 antitrypsin deficiency;
- Pregnancy or lactation period;
Who the study is looking for
- 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.
Age in the registry: 40 years to 120 years · Sex: All · Does not accept healthy volunteers
Sites (20)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.