Observational Retrospective Study on Clinical Outcomes of Patients Receiving Benralizumab in Spain.
- Conditions
- Severe Asthma
- Registration Number
- NCT04648839
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 221
- 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.
- Patients who received benralizumab in a clinicaltrial, during the observation period.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Physician office visits Baseline period Split by primary care and specialist (asthma related)
Total IgE Baseline period Gender Up to 12 months (Baseline period) Specifically, at the time of taking the first dose of study drug
Smoking Habits Up to 12 months (Baseline period) Age at athma diagnosis Up to 12 months (Baseline period) Severe asthma exacerbations In the previous 12 months Number of diagnostic/therapeutic tests per patient Baseline period Asthma related only
Number of allergy tests per patient Baseline period Age 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 Baseline period FeNo Baseline period ACT (or ACQ) score 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)Number of conventional radiology procedures per patient Baseline period Number of spirometries per patient Baseline period Number of magnetic resonance imaging procedures per patient Baseline period Blood eosinophils count Baseline period Lung function (FEV1 and FVC) Baseline period AQLQ score 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 Baseline period Concomitant asthma medications Baseline period Emergency room visits Baseline period OCS-related comorbidities Baseline period Number of laboratory tests per patient Baseline period Asthma treatment Up to 24 months (study duration) Including previous biologic treatment, type of treatment and reasons for discontinuation or switching
Hospitalisations Baseline period Number and duration
Number of computed axial tomographies per patient Baseline period
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Research Site
🇪🇸Madrid, Spain