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

IdentiFy attRibutes Of uNcontrolled Severe asThma Patients trEateD With Tezepelumab: Italian Clinical Practice Study With the New bioloGic targEting TSLP

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

Study Overview

• Status: Active, not recruiting
• Conditions: Asthma
• Intervention / Treatment: Biological: Tezepelumab

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.

• Study Type: Observational
• Enrollment (Actual): 315

Contacts and Locations

Study Locations

• Italy
  • 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
    • Research Site
  • Padova
    • Cittadella (PD), Padova, Italy
      • Research Site
  • TV
    • Montebelluna (TV), TV, Italy
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Biological: Tezepelumab; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2025
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027

Study Registration Dates

• First Submitted: April 9, 2025
• First Submitted That Met QC Criteria: April 24, 2025
• First Posted (Actual): April 29, 2025

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Asthma, uncontrolled severe asthma
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma; tezepelumab
• Other Study ID Numbers: D5180R00031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: 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
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL