NCT04272463

ChAracterisation of ItaliaN Severe Uncontrolled Asthmatic patieNts Key Features When Receiving Benralizumab

ChAracterisation of ItaliaN Severe Uncontrolled Asthmatic patieNts Key Features When Receiving Benralizumab in a Real Life Setting: an Observational rEtrospective Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 217 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 or as per normal clinical practice in Italy.

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: 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.

Conditions

• Severe Asthma

Interventions

Type	Name	Description
OTHER	No intervention	Patients currently in treatment with benralizumab as per approved indication and clinical practice

Timeline

• Start date: 2020-03-13
• Primary completion: 2020-07-15
• Completion: 2020-07-15
• First posted: 2020-02-17
• Last updated: 2023-08-31

Locations

18 sites across 1 country: Italy