NCT06948396Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 20 Jul 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 315 (actual)
- First submitted
- 9 Apr 2025
- Start date
- 25 Jun 2025
- Primary completion date
- 30 May 2027
- Lead sponsor
- AstraZeneca
- Diseases
- Asthma
- NCT number
- NCT06948396
What you commit to
- Study type: Observational
- Participants enrolled: 315
- From 25 Jun 2025 to the primary completion date, 30 May 2027
- 28 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Patients with hypersensitivity to the active ingredient or any of the excipients of Tezspire;
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 12 years to 120 years · Sex: All · Does not accept healthy volunteers
Sites (28)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.