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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Severe uncontrolled asthma patients | Adolescent and adult patients with severe uncontrolled asthma treated with tezepelumab will be enrolled in the study. Patients can be enrolled if they received at least one dose of tezepelumab either within the sampling program or as per routine clinical practice between February 2024 and March 2025. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tezepelumab | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic and Clinic characterization | To describe demographic and clinical characteristics of a population of patients with severe asthma who initiated treatment with tezepelumab | 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 | Basal |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Basal, 12 months, 24 months |
| mOCS (maintenance Oral Corticosteroids) and ICS (Inhaled Corticosteroids) use |
| Measure | Description | Time Frame |
|---|---|---|
| Demographics and clinic characterization_clinic remission | To describe baseline demographics and clinical characteristics associated with clinical remission, frequency and characteristics of tezepelumab-treated patients achieving clinical remission after 12 and 24 months. | 12 months, 24 months |
| HCRU - number of specialistic visits for asthma |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Cittadella (PD) | Padova | Italy | |||
| Research Site |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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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 |
| 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 | 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 | Basal, 12 months, 24 months |
| Lung function FEV1 (L) | To describe lung function through FEV1 (Forced Expiratory Volume in 1 Second) from last measurement 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. | Basal, 12 months, 24 months |
| Lung function FVC (L) | To describe lung function through FVC (Forced vital capacity) from last measurement 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. | Basal, 12 months, 24 months |
| Lung function % predicted FVC | To describe lung function through % predicted FVC (Forced vital capacity) from last measurement 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. | Basal, 12 months, 24 months |
| Lung function % predicted FEV1 | To describe lung function through % predicted FEV1 (Forced expiratory volume in 1 second) from last measurement 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. | Basal, 12 months, 24 months |
| Biomarkers - BEC (blood eosinophils count) | To describe BEC (cells/microL (cells/mm3)) 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. | Basal, 12 months, 24 months |
| Biomarkers - FeNO (Fractional exhaled Nitric Oxide) | To describe FeNO (ppb) 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. FeNo range 0-99 | Basal, 12 months, 24 months |
| Biomarkers - IgE (Immunoglobulin E) | To describe blood IgE (IU/mL) 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. | Basal, 12 months, 24 months |
| Treatments | To describe treatment of asthma in 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. | Basal, 12 months, 24 months |
| Clinical Remission | To describe frequency and characteristics of patients achieving partial and complete clinical remission after 12 months and 24 months of treatment (+/- 2 months) [Severe Asthma Network in Italy (SANI) 2023 definition] [Canonica G et al, 2023]. | 12 months, 24 months |
To describe total number of specialist visits for asthma 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. |
| Basal, 12 months, 24 months |
| HCRU - number of hospitalization | To describe total number of hospitalization 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. | Basal, 12 months, 24 months |
| HCRU - number of ER visits | To describe total number of ER visits 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. | Basal, 12 months, 24 months |
| NP clinical outcomes - NPS (Nasal Polyp Score) | To describe NPS (0-8) among severe asthma patients with comorbid CRSwNP during the baseline and follow-up period (12 and 24 months of treatment). NPS score: reduced score indicates improvement | Basal, 12 months, 24 months |
| NP clinical outcomes - Lund-Mackay (LMK) score | To describe LMK (0-24) among severe asthma patients with comorbid CRSwNP during the baseline and follow-up period (12 and 24 months of treatment). LMK 24 means complete opacity of all sinuses | Basal, 12 months, 24 months |
| NP clinical outcomes - Visual Analogue Scale (VAS) | To describe VAS (0-40) among severe asthma patients with comorbid CRSwNP during the baseline and follow-up period (12 and 24 months of treatment). VAS 40 means higher pain | Basal, 12 months, 24 months |
| NP clinical outcomes - 22-item Sino-Nasal Outcome Test (SNOT-22) | To describe SNOT-22 (0-110) among severe asthma patients with comorbid CRSwNP during the baseline and follow-up period (12 and 24 months of treatment). Higher scores indicate greater rhinosinusitis-related health burden | Basal, 12 months, 24 months |
| NP clinical outcomes - NP surgeries | To describe number of NP surgeries among severe asthma patients with comorbid CRSwNP during the baseline and follow-up period (12 and 24 months of treatment). Higher scores indicate greater rhinosinusitis-related health burden | Basal, 12 months, 24 months |
| Subgroups | To describe clinical outcomes from the primary, secondary, and/or exploratory objectives in sub-groups of interest | Basal, 12 months, 24 months |
| Tezepelumab treatment | To describe duration of therapy with tezepelumab, discontinuation, and reasons for discontinuation after initiating treatment with tezepelumab. | 12 months, 24 months |
| 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 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000622721 | tezepelumab |
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