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Italian asthma study tracks new biologic in real life

NCT ID NCT06948396

Knowledge-focused Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 21, 2026 · Updated 3 times

Summary

This observational study is collecting data from 315 patients in Italy who started treatment with tezepelumab for severe uncontrolled asthma. The goal is to describe their characteristics, medical history, and how their asthma exacerbation rates change over 12 to 24 months. It is not testing a new drug but gathering real-world information to better understand who benefits from this treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tezepelumab
What this could lead to
If successful, this study could provide real-world evidence on how tezepelumab works in everyday patients, potentially improving treatment guidelines for severe asthma.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by patient selection or other factors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

315 people

The number who actually took part.

Started

Jun 2025

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adolescent and adult patients with severe uncontrolled asthma treated with at least one dose of tezepelumab between February 2024 and March 2025 will be enrolled in the study.

Ages

12 to 120 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

asthma chronic asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma

Contacts and locations

Locations

  • Research Site

    Cittadella (PD), Padova, Italy

  • Research Site

    Montebelluna (TV), TV, Italy

  • 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

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