NCT06422676

MultIceNtre Non-intERVentional Study for Efficacy,Safety Evaluation of BREZTRI in Pts With COPD in RussiA

Open-label Single-arm, Non-interventional, Multi-centre, Cohort Study for Evaluation of Clinical and Patient Reported Outcomes in New Users of BREZTRI (Budesonide / Glycopyrronium / Formoterol) in Routine Care Settings

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a retrospective-prospective, non-interventional, multi-centre study that will be conducted in routine clinical settings in Russia. Eligible patients with moderate to severe COPD routinely treated with BREZTRI will be observed according to routine clinical practice for up to 24 weeks.

Detailed description

Chronic obstructive pulmonary disease (COPD) is a disease characterized by persistent airflow limitation that is usually progresses and is a consequence of a chronic inflammatory response of the respiratory pathways and lung tissue to the effects of inhaled harmful particles or gases. Exacerbations and comorbid conditions are an integral part of the disease and contribute significantly to the clinical picture and prognosis \[1\]. Patient-reported outcomes (both symptom-based and health-related quality of life-specific) are essential to evaluate symptoms, impact of symptoms on activities of daily living, and treatment response in COPD patients \[12\]. There is a need to evaluate the patient-reported outcomes during a triple therapy with budesonide + glycopyrronium bromide + formoterol (Breztri) in a real-life clinical practice. The aim of the study is to evaluate clinical and patient-reported outcomes of treatment with BREZTRI through effectiveness measures assessed pre- and post-treatment initiation and safety monitoring. The study results will be interpreted in the context of an open label, single arm study design where multiple factors, in addition to the new treatment, may contribute to the treatment effect.

Conditions

• Chronic Obstructive Pulmonary Disease

Timeline

• Start date: 2023-12-29
• Primary completion: 2024-12-18
• Completion: 2024-12-18
• First posted: 2024-05-21
• Last updated: 2025-10-15

Locations

14 sites across 1 country: Russia