Clinical trial NCT04648839: Observational Retrospective Study on Clinical Outcomes of Patients Receiving Benralizumab in Spain.
Official title: Observational Retrospective Study to Characterise and Assess Clinical Outcomes of Patients Receiving Benralizumab After Marketing Approval in Spain.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2020-12-02
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population will be all patients with severe eosinophilic asthma (those requiring stable treatment with high doses of inhaled corticosteroids and a long-acting agonist β2 ± additional asthma controller), who received at least one dose of benralizumab according to routine clinical practice, after marketing approval on January 1st, 2019. The targeted patients need to have available medical record of 12 months prior to index date.

Brief summary: 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.


Eligibility criteria: 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.

Exclusion Criteria:

* Patients who received benralizumab in a clinicaltrial, during the observation period.

Primary outcomes:
measure: Age
timeFrame: Up to 12 months (Baseline period)
measure: Gender
timeFrame: Up to 12 months (Baseline period)
measure: Smoking Habits
timeFrame: Up to 12 months (Baseline period)
measure: Age at athma diagnosis
timeFrame: Up to 12 months (Baseline period)
measure: Blood eosinophils count
timeFrame: Baseline period
measure: Total IgE
timeFrame: Baseline period
measure: Number of patients with positive Prick test
timeFrame: Baseline period
measure: FeNo
timeFrame: Baseline period
measure: Lung function (FEV1 and FVC)
timeFrame: Baseline period
measure: ACT (or ACQ) score
timeFrame: Baseline period
measure: AQLQ score
timeFrame: Baseline period
measure: Severe asthma exacerbations
timeFrame: In the previous 12 months
measure: Key comorbidities
timeFrame: Baseline period
measure: OCS-related comorbidities
timeFrame: Baseline period
measure: Concomitant asthma medications
timeFrame: Baseline period
measure: Physician office visits
timeFrame: Baseline period
measure: Emergency room visits
timeFrame: Baseline period
measure: Hospitalisations
timeFrame: Baseline period
measure: Number of laboratory tests per patient
timeFrame: Baseline period
measure: Number of conventional radiology procedures per patient
timeFrame: Baseline period
measure: Number of diagnostic/therapeutic tests per patient
timeFrame: Baseline period
measure: Number of spirometries per patient
timeFrame: Baseline period
measure: Number of allergy tests per patient
timeFrame: Baseline period
measure: Number of computed axial tomographies per patient
timeFrame: Baseline period
measure: Number of magnetic resonance imaging procedures per patient
timeFrame: Baseline period
measure: Asthma treatment
timeFrame: Up to 24 months (study duration)
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Research Site
Study officials:
References: