Observational Retrospective Study to Characterise and Assess Clinical Outcomes of Patients Receiving Benralizumab After Marketing Approval in Spain.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Severe Asthma
- Sponsor
- AstraZeneca
- Enrollment
- 221
- Locations
- 1
- Primary Endpoint
- Total IgE
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
Primary Objectives:
- 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
- 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.
Investigators
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.
Outcomes
Primary Outcomes
Total IgE
Time Frame: Baseline period
Gender
Time Frame: Up to 12 months (Baseline period)
Specifically, at the time of taking the first dose of study drug
Concomitant asthma medications
Time Frame: Baseline period
Smoking Habits
Time Frame: Up to 12 months (Baseline period)
Age at athma diagnosis
Time Frame: Up to 12 months (Baseline period)
Severe asthma exacerbations
Time Frame: In the previous 12 months
Number of diagnostic/therapeutic tests per patient
Time Frame: Baseline period
Asthma related only
Number of allergy tests per patient
Time Frame: Baseline period
Age
Time Frame: Up to 12 months (Baseline period)
Specifically, at the time of taking the first dose of study drug
Number of patients with positive Prick test
Time Frame: Baseline period
FeNo
Time Frame: Baseline period
ACT (or ACQ) score
Time Frame: Baseline period
Asthma Control Test (ACT), the scores range from 5 to 25, with higher scores reflecting greater asthma control. Asthma Control Questionnaire (ACQ), the total score range between 0 (well controlled asthma) and 6 (extremely poorly controlled)
Physician office visits
Time Frame: Baseline period
Split by primary care and specialist (asthma related)
Number of conventional radiology procedures per patient
Time Frame: Baseline period
Number of spirometries per patient
Time Frame: Baseline period
Number of magnetic resonance imaging procedures per patient
Time Frame: Baseline period
Blood eosinophils count
Time Frame: Baseline period
Lung function (FEV1 and FVC)
Time Frame: Baseline period
AQLQ score
Time Frame: Baseline period
Asthma Quality of Life Questionnaire (AQLQ), it scores from 1 (minimum) to 7 (maximum) where the higher the score, the better the quality of life is
Key comorbidities
Time Frame: Baseline period
Emergency room visits
Time Frame: Baseline period
OCS-related comorbidities
Time Frame: Baseline period
Number of laboratory tests per patient
Time Frame: Baseline period
Asthma treatment
Time Frame: Up to 24 months (study duration)
Including previous biologic treatment, type of treatment and reasons for discontinuation or switching
Hospitalisations
Time Frame: Baseline period
Number and duration
Number of computed axial tomographies per patient
Time Frame: Baseline period