NCT05078281

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

October 14, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

November 16, 2021

Status Verified

October 1, 2021

Enrollment Period

1.4 years

First QC Date

September 15, 2021

Last Update Submit

November 15, 2021

Conditions

Asthma; Eosinophilic

Outcome Measures

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.

    Up to 60 weeks.

Secondary Outcomes (1)

  • Study the response variables to benralizumab.

    Up to 60 weeks.

Study Arms (1)

Cases

Patients with severe eosinophilic asthma receiving benralizumab.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

RECRUITING

MeSH Terms

Conditions

Pulmonary Eosinophilia

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypereosinophilic SyndromeEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Ana Gómez-Ballesteros Fernández

    Hospital Universitario Virgen Macarena

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Gómez-Ballesteros Fernández

CONTACT

955008000ana.gomezbastero@gmail.com

Carlos García Perez

CONTACT

600162458administracion.eecc.hvm.sspa@juntadeandalucia.es

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2021

First Posted

October 14, 2021

Study Start

November 1, 2020

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

November 16, 2021

Record last verified: 2021-10

Locations

ES(1)