Clinical trial NCT06948396: Observational Study on the Clinical Profile of Patients With Uncontrolled Severe Asthma Treated With Tezepelumab in Italy
Official title: IdentiFy attRibutes Of uNcontrolled Severe asThma Patients trEateD With Tezepelumab: Italian Clinical Practice Study With the New bioloGic targEting TSLP
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Asthma
Keywords: Asthma, uncontrolled severe asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2025-04-29
Enrollment: 300
Sex: ALL
Minimum age (years): 12
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief 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

Detailed description: 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.

Eligibility criteria: 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 outcomes:
measure: Demographic and Clinic characterization
timeFrame: Basal
measure: COMORBIDITIES AND RELEVANT MEDICAL HISTORY
timeFrame: Basal
Secondary outcomes:
measure: Exacerbation rate
timeFrame: Basal, 12 months, 24 months
measure: mOCS (maintenance Oral Corticosteroids) and ICS (Inhaled Corticosteroids) use
timeFrame: Basal, 12 months, 24 months
measure: ACT (Asthma Control Test) score
timeFrame: Basal, 12 months, 24 months
measure: Asthma Control Questionnaire (ACQ) score
timeFrame: Basal, 12 months, 24 months
measure: Lung function FEV1 (L)
timeFrame: Basal, 12 months, 24 months
measure: Lung function FVC (L)
timeFrame: Basal, 12 months, 24 months
measure: Lung function % predicted FVC
timeFrame: Basal, 12 months, 24 months
measure: Lung function % predicted FEV1
timeFrame: Basal, 12 months, 24 months
measure: Biomarkers - BEC (blood eosinophils count)
timeFrame: Basal, 12 months, 24 months
measure: Biomarkers - FeNO (Fractional exhaled Nitric Oxide)
timeFrame: Basal, 12 months, 24 months
measure: Biomarkers - IgE (Immunoglobulin E)
timeFrame: Basal, 12 months, 24 months
measure: Treatments
timeFrame: Basal, 12 months, 24 months
measure: Clinical Remission
timeFrame: 12 months, 24 months
Other outcomes:
measure: Demographics and clinic characterization_clinic remission
timeFrame: 12 months, 24 months
measure: HCRU - number of specialistic visits for asthma
timeFrame: Basal, 12 months, 24 months
measure: HCRU - number of hospitalization
timeFrame: Basal, 12 months, 24 months
measure: HCRU - number of ER visits
timeFrame: Basal, 12 months, 24 months
measure: NP clinical outcomes - NPS (Nasal Polyp Score)
timeFrame: Basal, 12 months, 24 months
measure: NP clinical outcomes - Lund-Mackay (LMK) score
timeFrame: Basal, 12 months, 24 months
measure: NP clinical outcomes - Visual Analogue Scale (VAS)
timeFrame: Basal, 12 months, 24 months
measure: NP clinical outcomes - 22-item Sino-Nasal Outcome Test (SNOT-22)
timeFrame: Basal, 12 months, 24 months
measure: NP clinical outcomes - NP surgeries
timeFrame: Basal, 12 months, 24 months
measure: Subgroups
timeFrame: Basal, 12 months, 24 months
measure: Tezepelumab treatment
timeFrame: 12 months, 24 months
Locations:
Study officials:
References: