Clinical trial NCT05862545: Outcomes in Real-life After Initation of Treatment With Trixeo (Budesonide / Glycopyrronium / Formoterol)
Official title: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Pulmonary Disease, Chronic Obstructive, Patient Reported Outcome Measures
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-05-17
Enrollment: 250
Sex: ALL
Minimum age (years): 40
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of adult patients with moderate to severe COPD who are eligible for BGF therapy, enrolled consecutively by physicians in specialist setting. 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.

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.

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.

Primary outcomes:
measure: COPD Assessment Test (CAT) score
timeFrame: baseline, 12 weeks after treatment start
Secondary outcomes:
measure: Baseline features
timeFrame: Baseline
measure: Impact of COPD on patients' life based on CAT
timeFrame: baseline, 26 and 52 weeks
measure: Patients' satisfaction to BGF
timeFrame: baseline, 26 and 52 weeks
measure: Patient dyspnoea based on Modified Medical Research Council Dyspnoea Scale (mMRC)
timeFrame: Baseline, 26 and 52 weeks
measure: Eosinophil count
timeFrame: baseline, 26 and 52 weeks
measure: Responder Rate based on CAT
timeFrame: 12 weeks
measure: Overall change in health status based on Patient Global Impression of Severity (PGIS) questionnaire
timeFrame: Baseline, 12, 26 and 52 weeks
measure: Exacerbation rate
timeFrame: 52 weeks
measure: Lung function
timeFrame: 52 weeks
measure: OCS use
timeFrame: 52 weeks
measure: HCRU
timeFrame: 52 weeks
measure: Safety (frequency of all AEs, SAEs, AEs related to BGF and Special Situations during the observation period)
timeFrame: 52 weeks
Other outcomes:
measure: Relation between patient CAT score (dependent variable of interest) and patient baseline characteristics
timeFrame: 52 weeks
measure: Baseline variables associated with exacerbations
timeFrame: 52 weeks
measure: Occurrence of Major Cardiovascular Events (MACE)
timeFrame: 52 weeks
measure: Mortality rate
timeFrame: 52 weeks
Locations:
city: Acquaviva delle Fonti
country: Italy
facility: Research Site
city: Alessandria
country: Italy
facility: Research Site
city: Ancona
country: Italy
facility: Research Site
city: Avellino
country: Italy
facility: Research Site
city: Brescia
country: Italy
facility: Research Site
city: Brindisi
country: Italy
facility: Research Site
city: Busto Arsizio (Varese)
country: Italy
facility: Research Site
city: Catania
country: Italy
facility: Research Site
city: Catanzaro
country: Italy
facility: Research Site
city: Cittadella (Padova)
country: Italy
facility: Research Site
city: Firenze
country: Italy
facility: Research Site
city: Foggia
country: Italy
facility: Research Site
city: Lecce
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Passirana (Milano)
country: Italy
facility: Research Site
city: Pavia
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Torino
country: Italy
facility: Research Site
city: Treviso
country: Italy
facility: Research Site
city: Verona
country: Italy
facility: Research Site
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.