Clinical Trials in Italy / NCT07214753
Recruiting
Observational
A Real-life Observational Study in Severe Eosinophilic Asthma Adult Participant Treated With Benralizumab in Italy
NCT07214753 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Severe Eosinophilic Asthma
Study summary
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.
Eligibility
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
Primary outcome measure(s)
- Number and percentage of patients achieving clinical remission, partial and complete, as per SANI Definition — 24 months
Number and percentage of patient who met the 4 remission criteria (complete or partial) at 12 months and maintained up to 24months
Trial sites (28)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Salerno | Battipaglia | Not Yet Recruiting |
| Research Site | Padova | Cittadella | Not Yet Recruiting |
| Research Site | Teramo | Giulianova | Recruiting |
| Research Site | Treviso | Montebelluna | Recruiting |
| Research Site | Varese | Tradate | Recruiting |
| Research Site | Bari | Italy | Recruiting |
| Research Site | Bergamo | Italy | Not Yet Recruiting |
| Research Site | Bologna | Italy | Recruiting |
| Research Site | Bologna | Italy | Not Yet Recruiting |
| Research Site | Brescia | Italy | Not Yet Recruiting |
| Research Site | Catania | Italy | Not Yet Recruiting |
| Research Site | Catanzaro | Italy | Recruiting |
| Research Site | Florence | Italy | Not Yet Recruiting |
| Research Site | Foggia | Italy | Not Yet Recruiting |
| Research Site | Messina | Italy | Not Yet Recruiting |
| Research Site | Milan | Italy | Recruiting |
| Research Site | Modena | Italy | Recruiting |
| Research Site | Naples | Italy | Recruiting |
| Research Site | Naples | Italy | Not Yet Recruiting |
| Research Site | Padova | Italy | Not Yet Recruiting |
| Research Site | Palermo | Italy | Recruiting |
| Research Site | Pavia | Italy | Not Yet Recruiting |
| Research Site | Roma | Italy | Not Yet Recruiting |
| Research Site | Roma | Italy | Recruiting |
| Research Site | Sassari | Italy | Not Yet Recruiting |
| Research Site | Siena | Italy | Not Yet Recruiting |
| Research Site | Torino | Italy | Recruiting |
| Research Site | Verona | Italy | Not Yet Recruiting |
On this site
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07214753 on ClinicalTrials.gov ↗ ← All trials in Italy