Patients With Severe Eosinophilic Asthma Treated With Benralizumab

• Conditions: Asthma; Eosinophilic

• Registration Number: NCT05078281
• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Brief Summary

Retrospective, multicenter, routine clinical practice study with consecutive inclusion of adult patients with severe eosinophilic asthma receiving benralizumab treatment.

Detailed Description

Retrospective study studying severe eosinophilic asthma. Patients with this disease who are on benralizumab treatment for at least 4 months before the start of the study will be included.

The purpose of this study is to analyze the predictive factors of response in patients with this type of disease treated with benralizumab, who obtain a complete response during their follow-up.

The results of the study will be obtained through the review of medical records, where demographic characteristics such as age, gender and smoking will be assessed; presence of comorbidities; clinical-functional variables; response variables (exercises, cycles of oral corticosteroids, admissions, visits to the emergency room or unscheduled, cumulative dose of oral corticosteroids, absenteeism from work) and side effects.

Study Timeline

• Study Start: 2020-11-01
• Study First Submitted: 2021-09-15
• Study First Submitted QC: 2021-09-30
• Status Verified: 2021-10
• Study First Posted: 2021-10-14
• Last Update Submitted: 2021-11-15
• Last Update Posted: 2021-11-16
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Adult patients (over 18 years of age) diagnosed with severe eosinophilic asthma on benralizumab treatment for at least 4 months from the start of the study.

Exclusion Criteria

• Patients for whom no previous history is available or who do not meet the inclusion criteria.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response predictors in patients treated with benralicumab.	Up to 60 weeks.	To analyze response predictors in patients with severe eosinophilic asthma under treatment with benralizumab who obtain a complete response during their follow-up.

Secondary Outcome Measures

Name	Time	Method
Study the response variables to benralizumab.	Up to 60 weeks.	Number of visits to the emergency room or hospital admissions observed since the beginning of the study.

Trial Locations

Locations (1)

Hospital Universitario Virgen Macarena; 🇪🇸 Sevilla, Spain