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A Real-life Observational Study in Severe Eosinophilic Asthma Adult Participant Treated With Benralizumab in Italy
This is an observational, multicenter, prospective study on patients with severe eosinophilic asthma treated with benralizumab aimed at evaluating the achievement of partial and complete clinical remission.
ClinicalTrials.gov IDNCT07214753
PhaseNot Applicable
Enrollment335
SponsorAstraZeneca
Age18 Years
SexALL
Conditions studied
Severe Eosinophilic Asthma
About this study
This is an observational, multicenter, prospective study on patients with severe eosinophilic asthma treated with benralizumab aimed at evaluating the achievement of partial and complete clinical remission.
Interventions
- Biological: benralizumab — 30mg s.c. as per SmPC
Primary outcomes
- Number and percentage of patients achieving clinical remission, partial and complete, as per SANI Definition (24 months)
Eligibility information
Inclusion Criteria:
* Adults (≥ 18 years old) diagnosed with severe uncontrolled eosinophilic asthma.
* Benralizumab has been prescribed according to the approved label and local reimbursement criteria
* Provision of signed Informed Consent Form (ICF) prior to any study-related activities
* Benralizumab has been initiated within 7 days prior to study enrollment or is planned to be initiated within 7 days after enrollment (in the latter case, provided that the decision to prescribe benralizumab is made prior to the decision to enroll the patient in the study).
Exclusion Criteria:
* Benralizumab treatment within the 12 months prior to study enrollment and up to 8 days before enrollment
* Previous participation (in the 12 months before enrollment), current participation or plan to participate within the follow up period to any other clinical trial.
* Contraindication to benralizumab as per current Summary of Product Characteristics (SmPC).
* Pregnant or lactating women.
* patients with any clinical condition that may interfere with the subject's ability to cooperate and comply with the study procedures based on the Investigator's judgement.
* Previous or concomitant use of omalizumab, reslizumab, dupilumab, tezepelumab or mepolizumab without washout period as per clinical practice
Study locations
- Research Site, Salerno, Battipaglia 84031 Italy
- Research Site, Padova, Cittadella 35013 Italy
- Research Site, Teramo, Giulianova 64021 Italy
- Research Site, Treviso, Montebelluna 31044 Italy
- Research Site, Varese, Tradate 21049 Italy
- Research Site, Bari, 70120 Italy
- Research Site, Bergamo, 24127 Italy
- Research Site, Bologna, 40138 Italy
- Research Site, Bologna, 40139 Italy
- Research Site, Brescia, 25123 Italy
Showing 10 of 28 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-30.