🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Italy / NCT06948396
Active, not recruiting Observational

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

NCT06948396 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-06-25
Last updated
2026-07-20

Condition(s) studied

Asthma

Investigational drug(s) / intervention(s)

Tezepelumab →

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

Study 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

Sex
ALL
Min age
12 Years
Max age
120 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (28)

FacilityCityRegionStatus
Research Site Cittadella (PD) Padova
Research Site Montebelluna (TV) TV
Research Site Aosta Italy
Research Site Avellino Italy
Research Site Bari Italy
Research Site Bergamo Italy
Research Site Brescia Italy
Research Site Cagliari Italy
Research Site Catania Italy
Research Site Catanzaro Italy
Research Site Civitanova Marche Italy
Research Site Ferrara Italy
Research Site Foggia Italy
Research Site Garbagnate(MI) Italy
Research Site Genova Italy
Research Site Lamezia Terme Italy
Research Site Massa Carrara Italy
Research Site Milan Italy
Research Site Modena Italy
Research Site Naples Italy
Research Site Orbassano (TO) Italy
Research Site Padova Italy
Research Site Reggio Emilia Italy
Research Site Roma Italy
Research Site Sassari Italy
Research Site Torino Italy
Research Site Tradate (VA) Italy
Research Site Verona Italy

On this site

📄 Tezspire (tezepelumab) drug profile →

More AstraZeneca trials in Italy

Other trials for the same condition

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 NCT06948396 on ClinicalTrials.gov ↗ ← All trials in Italy