RecruitingNCT06948396
Observational Study on the Clinical Profile of Patients With Uncontrolled Severe Asthma Treated With Tezepelumab in Italy
IdentiFy attRibutes Of uNcontrolled Severe asThma Patients trEateD With Tezepelumab: Italian Clinical Practice Study With the New bioloGic targEting TSLP
Sponsor
AstraZeneca
Enrollment
300 participants
Start Date
Jun 25, 2025
Study Type
OBSERVATIONAL
Conditions
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 indication in Italy
Eligibility
Min Age: 12 YearsMax Age: 120 Years
Inclusion Criteria6
- 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 Criteria3
- 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.
Interventions
BIOLOGICALTezepelumab
Tezepelumab is indicated as an add-on maintenance treatment in adult and adolescent ≥12 years patients with severe uncontrolled asthma despite high-dose inhaled corticosteroids plus long-acting β-agonists
Locations(30)
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NCT06948396
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