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

NCT ID: NCT05862545

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2025-05-31

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 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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

BGF (budesonide/glycopyrrolate/formoterol fumarate)

Intervention Type: DRUG

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.

Interventions

BGF (budesonide/glycopyrrolate/formoterol fumarate)

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.

Intervention Type: DRUG

Eligibility Criteria

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, local market 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 Criteria

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

2. Patients with controlled COPD treated with triple fixed-dose combination in 12 months 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 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Napoli, , 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

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 30863039 (View on PubMed)

Bourbeau 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.

Reference Type: BACKGROUND

PMID: 33688176 (View on PubMed)

Zheng 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.

Reference Type: BACKGROUND

PMID: 30401700 (View on PubMed)

Other Identifiers

D5980R00076

Identifier Type: -

Identifier Source: org_study_id