Outcomes in Real-life After Initation of Treatment With Trixeo (Budesonide / Glycopyrronium / Formoterol)

Last updated: June 25, 2025
Sponsor: AstraZeneca
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

BGF (budesonide/glycopyrrolate/formoterol fumarate)

Clinical Study ID

NCT05862545
D5980R00076
  • Ages 40-120
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female, aged >= 40;

  2. Physician-diagnosed COPD;

  3. Signed written informed and privacy consent prior to study participation;

  4. Patients starting treatment with BGF as prescribed according to the label, localmarket reimbursement criteria, and AIFA Nota 99;

  5. 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

Exclusion Criteria:

  1. COPD due to documented α-1 antitrypsin deficiency;

  2. Patients with controlled COPD treated with triple fixed-dose combination in 12months prior to screening visits;

  3. Hospitalisation due to COPD exacerbation within the last 30 days prior to enrolment;

  4. Pregnancy or lactation period;

  5. Participation in a non-interventional observational trial that might, in theinvestigator's opinion, influence the assessment for the current study, orparticipation in any interventional, observational or clinical trial in the last 30days prior to enrolment.

Study Design

Total Participants: 250
Treatment Group(s): 1
Primary Treatment: BGF (budesonide/glycopyrrolate/formoterol fumarate)
Phase:
Study Start date:
June 01, 2023
Estimated Completion Date:
May 31, 2025

Study Description

The therapeutic goal of chronic obstructive pulmonary disease (COPD) management is mainly reduction of symptoms and severity of exacerbations.Triple 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].

Budesonide/glycopyrrolate/formoterol 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.

Connect with a study center

  • Research Site

    Acquaviva delle Fonti,
    Italy

    Site Not Available

  • Research Site

    Alessandria,
    Italy

    Site Not Available

  • Research Site

    Ancona,
    Italy

    Site Not Available

  • Research Site

    Avellino,
    Italy

    Site Not Available

  • Research Site

    Brescia,
    Italy

    Site Not Available

  • Research Site

    Brindisi,
    Italy

    Site Not Available

  • Research Site

    Busto Arsizio,
    Italy

    Site Not Available

  • Research Site

    Busto Arsizio (Varese),
    Italy

    Site Not Available

  • Research Site

    Catania,
    Italy

    Site Not Available

  • Research Site

    Catanzaro,
    Italy

    Site Not Available

  • Research Site

    Cittadella (Padova),
    Italy

    Site Not Available

  • Research Site

    Firenze,
    Italy

    Site Not Available

  • Research Site

    Foggia,
    Italy

    Site Not Available

  • Research Site

    Garbagnate,
    Italy

    Site Not Available

  • Research Site

    Lecce,
    Italy

    Site Not Available

  • Research Site

    Napoli,
    Italy

    Site Not Available

  • Ospedale di Cittadella

    Padova,
    Italy

    Site Not Available

  • Research Site

    Passirana (Milano),
    Italy

    Site Not Available

  • Research Site

    Pavia,
    Italy

    Site Not Available

  • Research Site

    Roma,
    Italy

    Site Not Available

  • Research Site

    Siena,
    Italy

    Site Not Available

  • Research Site

    Torino,
    Italy

    Site Not Available

  • Research Site

    Treviso,
    Italy

    Site Not Available

  • Research Site

    Trieste,
    Italy

    Site Not Available

  • Research Site

    Verona,
    Italy

    Site Not Available

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