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

N/AActive Not RecruitingNCT06948396

AstraZeneca315 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

315

Conditions

Asthma

Interventions

TezepelumabBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 12 YearsMax age: 120 Years

Medical Language ↔ Plain English

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.

Locations (28)

Research Site

Cittadella (PD), Padova, Italy

Research Site

Montebelluna (TV), TV, Italy

Outcomes

Primary Outcomes

Demographic and Clinic characterization

To describe demographic and clinical characteristics of a population of patients with severe asthma who initiated treatment with tezepelumab

Time frame: Basal

COMORBIDITIES AND RELEVANT MEDICAL HISTORY

To describe the respiratory and non-respiratory related conditions in patients with severe asthma who initiated treatment with tezepelumab

Time frame: Basal

Secondary Outcomes

Exacerbation rate

To describe the annualized asthma exacerbation rate in the 12-month period before (baseline period) and up to 12 and 24-months (follow-up period) after initiating treatment with tezepelumab in patients with severe asthma.

Time frame: Basal, 12 months, 24 months

mOCS (maintenance Oral Corticosteroids) and ICS (Inhaled Corticosteroids) use

To describe the mOCS and ICS daily dose in the 12-month period before (baseline period) and up to 12 and 24-months (+/- 2 months, follow-up period) after initiating treatment with tezepelumab in patients with severe asthma

Time frame: Basal, 12 months, 24 months

ACT (Asthma Control Test) score

To describe asthma control (ACT score) from last ACT score recorded before index date (within 12-month baseline period) and up to 12 and 24-months (+/- 2 months, follow-up period) after initiating treatment with tezepelumab in patients with severe asthma. ACT score range 1-25 - 25 means sympthoms under control

Time frame: Basal, 12 months, 24 months

Asthma Control Questionnaire (ACQ) score

To describe ACQ score from last score recorded before index date (within 12-month baseline period) and up to 12 and 24-months (+/- 2 months, follow-up period) after initiating treatment with tezepelumab in patients with severe asthma. ACQ score range 0-6. 6 means severely uncontrolled

Data from ClinicalTrials.gov

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