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NCT Number: NCT06948396

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

12 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Cittadella (PD), Padova, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult and adolescent patients (age ≥12 years) at the Index Date (i.e., first administration of tezepelumab);
  • 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;
  • Patients who received at least one injection of tezepelumab from February 2024 to March 2025 , according to Italian reimbursement indications;
  • Patients who signed the ICF and privacy form.
  • Patients with continuous enrolment in the data source for at least 12-months before the index date.
  • Patients with at least three months of continuous enrolment in the data source after the index date.

Exclusion criteria

  • Patients with hypersensitivity to the active ingredient or any of the excipients of Tezspire;
  • 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.
  • 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.

Treatment and study plan

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

Primary outcomes

  1. Demographic and Clinic characterization

    Time frame: Basal

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

  2. COMORBIDITIES AND RELEVANT MEDICAL HISTORY

    Time frame: Basal

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

Secondary outcomes

  1. Exacerbation rate

    Time frame: Basal, 12 months, 24 months

    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.

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

    Time frame: Basal, 12 months, 24 months

    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

  3. ACT (Asthma Control Test) score

    Time frame: Basal, 12 months, 24 months

    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

  4. Asthma Control Questionnaire (ACQ) score

    Time frame: Basal, 12 months, 24 months

    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

  5. Lung function FEV1 (L)

    Time frame: Basal, 12 months, 24 months

    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.

  6. Lung function FVC (L)

    Time frame: Basal, 12 months, 24 months

    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.

  7. Lung function % predicted FVC

    Time frame: Basal, 12 months, 24 months

    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.

  8. Lung function % predicted FEV1

    Time frame: Basal, 12 months, 24 months

    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.

  9. Biomarkers - BEC (blood eosinophils count)

    Time frame: Basal, 12 months, 24 months

    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.

  10. Biomarkers - FeNO (Fractional exhaled Nitric Oxide)

    Time frame: Basal, 12 months, 24 months

    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

  11. Biomarkers - IgE (Immunoglobulin E)

    Time frame: Basal, 12 months, 24 months

    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.

  12. Treatments

    Time frame: Basal, 12 months, 24 months

    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.

  13. Clinical Remission

    Time frame: 12 months, 24 months

    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].

Other outcomes

  1. Demographics and clinic characterization_clinic remission

    Time frame: 12 months, 24 months

    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.

  2. HCRU - number of specialistic visits for asthma

    Time frame: Basal, 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.

  3. HCRU - number of hospitalization

    Time frame: Basal, 12 months, 24 months

    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.

  4. HCRU - number of ER visits

    Time frame: Basal, 12 months, 24 months

    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.

  5. NP clinical outcomes - NPS (Nasal Polyp Score)

    Time frame: Basal, 12 months, 24 months

    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

  6. NP clinical outcomes - Lund-Mackay (LMK) score

    Time frame: Basal, 12 months, 24 months

    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

  7. NP clinical outcomes - Visual Analogue Scale (VAS)

    Time frame: Basal, 12 months, 24 months

    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

  8. NP clinical outcomes - 22-item Sino-Nasal Outcome Test (SNOT-22)

    Time frame: Basal, 12 months, 24 months

    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

  9. NP clinical outcomes - NP surgeries

    Time frame: Basal, 12 months, 24 months

    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

  10. Subgroups

    Time frame: Basal, 12 months, 24 months

    To describe clinical outcomes from the primary, secondary, and/or exploratory objectives in sub-groups of interest

  11. Tezepelumab treatment

    Time frame: 12 months, 24 months

    To describe duration of therapy with tezepelumab, discontinuation, and reasons for discontinuation after initiating treatment with tezepelumab.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: FRONTEDGE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 29, 2025
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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