Observational Retrospective Study on Clinical Outcomes of Patients Receiving Benralizumab in Spain.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

221 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-16

Study Completion Date

2021-07-16

Brief Summary

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Primary Objectives:

1. To describe the demographic and baseline characteristics in patients with severe eosinophilic asthma in Spain who received at least one dose of Benralizumab, after its marketing authorization
2. To describe background treatment patterns of severe eosinophilic asthma patients at baseline and after the index date (benralizumab initiation)

This is a descriptive, observational, multi-centre, longitudinal, retrospective cohort study in adults patients (≥18 years) with severe asthma (maintenance treatment with high dose inhaled corticosteroids combined with long-acting agonist β2) and eosinophilic phenotype, who, at the discretion of the physician, received benralizumab accordingly to the clinical practice, in the period after the marketing authorization of benralizumab in Spain, on January 1st 2019.

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Detailed Description

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Conditions

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Severe Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Benralizumab

Patients that received at least one dose of benralizumab according to routine clinical practice

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adult patients (age ≥18 years)
* Diagnosis of severe eosinophilic asthma requiring stable treatment of high doses of inhaled corticosteroids and a long-acting agonist β2 ± additional asthma controller.
* Patients with at least 12-month data available before index date (starting benralizumab treatment)
* Patients with at least 3-month electronic medical records data available from first benralizumab dose ("index date")
* Informed consent signed.