International Observational Study of BreztriTrixeo in Adults with Moderate to Severe COPD Evaluating Clinical and Patient-Reported Outcomes Over 12 Months

What this Trial Is About

Chronic Obstructive Pulmonary Disease COPD is a major global health issue, leading to high morbidity and mortality, especially in low- and middle-income countries. Frequent exacerbations worsen the disease and increase death risk. Current guidelines recommend triple inhaled therapy combining an inhaled corticosteroid, a long-acting muscarinic antagonist, and a long-acting beta2-agonist for patients with persistent symptoms. BreztriTrixeo BGF is one such therapy approved based on controlled clinical trials, but real-world data on its effectiveness and patient experience is needed. This observational study, called iCHOROS, will follow adults with moderate to severe COPD treated with BGF in routine clinical settings across Latin America, Asia, and the Middle East & Africa. Participants will be observed for 12 months after starting BGF, with assessments at baseline, 12, 26, and 52 weeks. The study collects clinical data and patient-reported outcomes without altering the standard care or providing study medication, focusing on real-life use and effects of BGF. Participants will have their COPD status, symptom scores, lung function, exacerbation history, and treatment satisfaction recorded during scheduled visits. The main measure is the change in COPD Assessment Test CAT score after 12 weeks. Additional measures include exacerbation rates, dyspnea severity, spirometry, and patient satisfaction with inhalers. The study aims to provide insights into BGFs impact in diverse populations over one year of follow-up.

Study of Clinical and Patient-reported Outcomes in Adults With Moderate to Severe COPD Treated With Breztri/Trixeo