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

CompletedN/A

Sponsor: AstraZeneca

Conditions: Chronic Obstructive Pulmonary Disease

Interventions: BGF (budesonide/glycopyrrolate/formoterol fumarate)

Countries: Italy

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 overview

Sex: ALL

Age: 40 Years to 120 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

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.

Locations (20)

Acquaviva delle Fonti, Italy
Alessandria, Italy
Ancona, Italy
Avellino, Italy
Brescia, Italy
Brindisi, Italy
Busto Arsizio (Varese), Italy
Catania, Italy
Catanzaro, Italy
Cittadella (Padova), Italy
Florence, Italy
Foggia, Italy
Lecce, Italy
Naples, Italy
Passirana (Milano), Italy
Pavia, Italy
Roma, Italy
Torino, Italy
Treviso, Italy
Verona, Italy