NCT06948396

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 12 Years – 120 Years
• Healthy volunteers: Not accepted

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

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 Tezepelumab the latest approved biologic drug for severe asthma, it is important to better understand clinical response to treatment in patients with high severe asthma burden as: patients with allergic-eosinophilic phenotype; patients with low eosinophils level; patients affected by severe asthma associated with sinonasal disease; biologic-naïve patients, as well as bio-treated patients. The present observational study aims at filling the above-mentioned knowledge gaps in the study population in terms of clinical course, disease control and clinical remission, use of healthcare resources (treatments, visits, hospitalizations), lung functions, biomarkers, and sinonasal outcomes.

Conditions

• Asthma

Interventions

Type	Name	Description
BIOLOGICAL	Tezepelumab	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

Timeline

• Start date: 2025-06-25
• Primary completion: 2027-05-30
• Completion: 2027-05-30
• First posted: 2025-04-29
• Last updated: 2026-03-02

Locations

30 sites across 1 country: Italy