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Clinical Trials/NCT05078281
NCT05078281UnknownNot Applicable

Predictive Response Factors in Respondent Patients and Results After Monoplane Switch in Patients With Severe Eosinophilic Asthma Treated With Benralizumab

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla1 site in 1 country60 target enrollmentStarted: November 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
60
Locations
1
Primary Endpoint
Response predictors in patients treated with benralicumab.

Study Overview

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 Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Response predictors in patients treated with benralicumab.

Time Frame: 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 Outcomes

  • Study the response variables to benralizumab.(Up to 60 weeks.)

Investigators

Study Sites (1)

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