CClinicalTrials.gg
Status unknownNCT05078281AsthmaUpdated Nov 16, 2021

Patients With Severe Eosinophilic Asthma Treated With Benralizumab

An observational study in Asthma; Eosinophilic, sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-16.

Sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Observational

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

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Conditions studied

  • Asthma; Eosinophilic
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In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's planned enrollment of 60 is below the median of 150 across 970 observational studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla is the lead sponsor of 119 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All patients with severe eosinophilic asthma receiving benralizumab belonging to the health area of each center, in the Pulmonology and Allergology units, will be included. Patients must have at least 4 months of benralizumab treatment at the start of the study.

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

Exclusion Criteria:

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

Observational model
Case-only
Time perspective
Retrospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • Cases

    Patients with severe eosinophilic asthma receiving benralizumab.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 60 weeks.

Secondary outcomes

  1. Study the response variables to benralizumab.

    Number of visits to the emergency room or hospital admissions observed since the beginning of the study.

    Time frame: Up to 60 weeks.

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05078281
Lead sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Responsible party
Sponsor
First posted
Oct 14, 2021
Start date
Nov 1, 2020
Primary completion
Apr 1, 2022 (estimated)
Completion
Apr 1, 2022 (estimated)
Last update
Nov 16, 2021

Study contacts

Ana Gómez-Ballesteros Fernández
Contact
ana.gomezbastero@gmail.com
955008000
Carlos García Perez
Contact
administracion.eecc.hvm.sspa@juntadeandalucia.es
600162458
Ana Gómez-Ballesteros Fernández
principal investigator · Hospital Universitario Virgen Macarena

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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