NCT05271526

Real World Evidence of Benralizumab in Eosinophilic Severe AsThma in Russia (BEST)

A Multicenter, Single Arm, Non-interventional, Observational, Prospective Study to Assess Demographic Characteristics, Burden of Disease and Short-term Patient Reported Outcomes on Symptom Relief in Severe Eosinophilic Asthma Patients Aged Older Than 18 Qualifying for Treatment With Benralizumab in Russia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Benralizumab is a humanised, afucosylated, monoclonal antibody against the interleukin (IL)-5 receptor (IL-5R) α subunit that induces direct, rapid, and near-complete depletion of eosinophils in blood, airway tissue, and bone marrow through enhanced antibody-dependent cell-mediated cytotoxicity (ADCC). This apoptotic process involves natural killer cells responsible for the controlled eosinophilic elimination. In the two pivotal phase III trials SIROCCO and CALIMA, benralizumab was well tolerated, significantly reduced asthma exacerbations by up to 51%, and improved lung function as well as disease control in patients with severe, uncontrolled asthma and blood eosinophil count of ≥ 300 cells/μL blood, receiving both ICS and LABA. According to the summary of product's characteristics (SmPC) of benralizumab in Russia, it can be used for an add-on maintenance treatment for adult patients with severe eosinophilic asthma. All patients enrolled in the BEST study will comply with the SmPC approved by the Russian Ministry of Health.

Detailed description

This is a multicentre, single arm, non-interventional observational, prospective study that will include patients older than 18 years, who qualify for the treatment with benralizumab according to the SmPC in participating research centres (study cites) focusing on severe eosinophilic asthma in Russia. The decision by the physician to start benralizumab is made independently from study inclusion and patient informed consent. Patients who meet the study criteria will be enrolled and, as outlined in the current label of benralizumab approved by Russian Ministry of Health, are planned to receive 3 subcutaneously (s.c.) applied doses of 30 mg benralizumab, from weeks 0 (baseline) every 4 weeks and then every 8 week. A follow-up visit to assess the sustainability of achieved changes will be done after 56 weeks. No study drug will be provided, all patients will be on commercially available drug. Additional two study visits at week 1 and 2 can also be done remotely via phone calls to obtain the paper-based SGRQ, ACQ-5, PGI-C and PGI-S questionnaires.

Conditions

• Severe Eosinophilic Asthma

Timeline

• Start date: 2022-05-16
• Primary completion: 2023-11-13
• Completion: 2023-11-13
• First posted: 2022-03-09
• Last updated: 2024-10-21

Locations

1 site across 1 country: Russia