Patients With Severe Eosinophilic Asthma Treated With Benralizumab

Asthma; Eosinophilic Clinical Trial

— Asthma  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05078281
• Other study ID #: FIS-BEN-2020-01
• Status: Recruiting
• Start date: November 1, 2020
• Est. completion date: April 1, 2022

Study information

• Verified date: October 2021
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: Ana Gómez-Ballesteros Fernández
• Phone: 955008000
• Email: ana.gomezbastero[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Asthma; Eosinophilic
• Pulmonary Eosinophilia

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen Macarena	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response predictors in patients treated with benralicumab.	To analyze response predictors in patients with severe eosinophilic asthma under treatment with benralizumab who obtain a complete response during their follow-up.	Up to 60 weeks.
Secondary	Study the response variables to benralizumab.	Number of visits to the emergency room or hospital admissions observed since the beginning of the study.	Up to 60 weeks.