Study identifier:D3250R00073
ClinicalTrials.gov identifier:NCT04272463
EudraCT identifier:N/A
CTIS identifier:N/A
ChAracterisation of ItaliaN severe uncontrolled Asthmatic patieNts Key features when receiving Benralizumab in a real life setting: an observational rEtrospective study
Severe Asthma
N/A
No
-
All
217
Observational
n/a - n/a
Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 Aug 2023 by AstraZeneca
AstraZeneca
-
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 or as per normal clinical practice in Italy.
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: in fact, since the Italian Sampling Program on benralizumab was active since July 2018, clinical data on patients exposed to benralizumab are already available. No treatments will be administered per protocol requirement, but instead according to normal clinical practice; since benralizumab first administration occurs before inclusion in the study (as per chosen study design), the decision to include the patient in the study is clearly separated from the prescription of benralizumab, in accordance with the observational nature of the study. In order to be eligible for the study, for each patient, the index date shall be at least 3 months prior to enrollment.
Location
Location
Garbagnate Milanese, Italy
Location
Torino, Italy
Location
Acquaviva delle Fonti, Italy
Location
Ostuni, Italy
Location
Roma, Italy
Location
Reggio Emilia, Italy
Location
Siena, Italy
Location
Catanzaro, Italy
Arms | Assigned Interventions |
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