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Active Not Recruiting NCT06948396

Observational Study on the Clinical Profile of Patients With Uncontrolled Severe Asthma Treated With Tezepelumab in Italy

Conditions: Asthma

Sex: All
Ages: 12 Years – 120 Years
Healthy volunteers: No
Enrollment: 315
Sponsor: AstraZeneca

Location: Research Site Cittadella (PD) Padova

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 Criteria

Inclusion Criteria: 1. Adult and adolescent patients (age ≥12 years) at the Index Date (i.e., first administration of tezepelumab); 2. 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; 3. Patients who received at least one injection of tezepelumab from February 2024 to March 2025 , according to Italian reimbursement indications; 4. Patients who signed the ICF and privacy form. 5. Patients with continuous enrolment in the data source for at least 12-months before the index date. 6. Patients with at least three months of continuous enrolment in the data source after the index date. Exclusion Criteria: 1. Patients with hypersensitivity to the active ingredient or any of the excipients of Tezspire; 2. 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. 3. 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06948396). StuddyBuddy aggregates publicly available trial information.