Status:
RECRUITING
Observational Study on the Clinical Profile of Patients With Uncontrolled Severe Asthma Treated With Tezepelumab in Italy
Lead Sponsor:
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
12-120 years
Brief Summary
This observational study aims to collect data in clinical practice on the clinical profile of patients treated with Tezepelumab from Q1 2024 to Q1 2025 according to the approved and reimbursed indicat...
Detailed Description
There is a current need to gain information on the clinical profile of patients eligible for treatment with Tezepelumab according to the approved and reimbursed indication in Italy. Moreover, being Te...
Eligibility Criteria
Inclusion
- Adult and adolescent patients (age ≥12 years) at the Index Date (i.e., first administration of tezepelumab);
- Patients with severe uncontrolled asthma (diagnosed according to clinician's judgment as per ERS-ATS or GINA guidelines) requiring a stable treatment of high doses of ICS and a long acting β2 agonist ± additional asthma controller;
- Patients who received at least one injection of tezepelumab from February 2024 to March 2025 , according to Italian reimbursement indications;
- Patients who signed the ICF and privacy form.
- Patients with continuous enrolment in the data source for at least 12-months before the index date.
- Patients with at least three months of continuous enrolment in the data source after the index date.
Exclusion
- Patients with hypersensitivity to the active ingredient or any of the excipients of Tezspire;
- Patients who received any biologic drug for the treatment of asthma in a clinical trial at any time during the 12-months prior to the index date.
- 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 :
September 10 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 30 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06948396
Start Date
September 10 2025
End Date
May 30 2027
Last Update
November 25 2025
Active Locations (30)
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1
Research Site
Garbagnate Milanese, Milano, Italy
2
Research Site
Cittadella, Padova, Italy
3
Research Site
Montebelluna, TV, Italy
4
Research Site
Aosta, Italy