Status:
COMPLETED
ChAracterisation of ItaliaN Severe Uncontrolled Asthmatic patieNts Key Features When Receiving Benralizumab
Lead Sponsor:
AstraZeneca
Conditions:
Severe Asthma
Eligibility:
All Genders
Brief Summary
This is an observational, Italian multi-center, retrospective cohort study with enrollment visit on patients suffering from severe eosinophilic asthma who started benralizumab in the Sampling Program ...
Detailed Description
A retrospective cohort study design involving secondary data collection was chosen to appropriately address the primary objective in a relatively short period of time after enrollment phase initiation...
Eligibility Criteria
Inclusion
- Adult patients (age ≥18 years) at the start of benralizumab treatment within the sampling program or per clinical practice ("index date").
- Patients with severe eosinophilic asthma requiring a stable treatment of high doses of inhaled corticosteroids and a long acting β2 agonist ± additional asthma controller (according to clinician's judgment).
- Patients who started benralizumab and received at least one injection at least 3 months before enrollment, either within the sampling program or as per routine clinical practice.
- Patients who signed the informed consent and privacy form at enrollment visit.
- Patients with available hospital medical chart since the start of benralizumab treatment within the sampling program or per clinical practice ("index date").
Exclusion
- Patients who, during the observation period, received benralizumab in a clinical experimental trial.
- Patients who, during the observation period, participated in studies imposing a specific patient's management strategy which does not correspond to the site's normal clinical practice.
Key Trial Info
Start Date :
March 13 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 15 2020
Estimated Enrollment :
217 Patients enrolled
Trial Details
Trial ID
NCT04272463
Start Date
March 13 2020
End Date
July 15 2020
Last Update
August 31 2023
Active Locations (18)
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1
Research Site
Acquaviva delle Fonti, Italy
2
Research Site
Bergamo, Italy
3
Research Site
Cassano Murge, Italy
4
Research Site
Catanzaro, Italy