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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 250
- Locations
- 20
- Primary Endpoint
- COPD Assessment Test (CAT) score
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 40 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
- •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.
Arms & Interventions
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)
Intervention: BGF (budesonide/glycopyrrolate/formoterol fumarate) (Drug)
Outcomes
Primary Outcomes
COPD Assessment Test (CAT) score
Time Frame: baseline, 12 weeks after treatment start
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
Secondary Outcomes
- Patients' satisfaction to BGF(baseline, 26 and 52 weeks)
- Overall change in health status based on Patient Global Impression of Severity (PGIS) questionnaire(Baseline, 12, 26 and 52 weeks)
- HCRU(52 weeks)
- Baseline features(Baseline)
- Responder Rate based on CAT(12 weeks)
- Lung function(52 weeks)
- Impact of COPD on patients' life based on CAT(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)
- Exacerbation rate(52 weeks)
- OCS use(52 weeks)
- Safety (frequency of all AEs, SAEs, AEs related to BGF and Special Situations during the observation period)(52 weeks)