Observational Study on the Clinical Profile of Patients With Uncontrolled Severe Asthma Treated W… (NCT06948396) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Observational Study on the Clinical Profile of Patients With Uncontrolled Severe Asthma Treated With Tezepelumab in Italy
Italy315 participantsStarted 2025-06-25
Plain-language 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
Who can participate
Age range
12 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is an observational study that is no longer actively recruiting, is there any chance I could still be included, or should we focus on other options for managing my severe asthma?
2This study is specifically tracking patients in Italy who are being treated with tezepelumab — is tezepelumab something you'd consider for my case, and what would it mean for me to be on that treatment regardless of this study?
3Because this trial is mainly collecting information about patient profiles and medical history rather than testing a new treatment, what would I actually gain from being part of it compared to just receiving standard care for my severe asthma?
4The study is looking closely at comorbidities and relevant medical history — are there specific conditions I have that would be particularly relevant to how well tezepelumab tends to work, based on what's been observed so far?
5Since this is a real-world observational study rather than a controlled trial, what does that tell us about the current evidence for tezepelumab, and are there stronger sources of data we should be looking at when deciding on my treatment plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.