AsthmaFRONTEDGENCT06948396
Observational Study on the Clinical Profile of Patients With Uncontrolled Severe Asthma Treated With Tezepelumab in Italy
An observational study of Asthma, run by AstraZeneca at 28 sites in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 12 to 120 years
- Conditions the study is for
- Asthma
- What is being tested?
- Tezepelumab
- How many people
- 315 participants
- Where
- 28 sitesItaly
- Study dates
- 25 Jun 2025to 30 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
Italy28 sites
Research Site
Aosta
Research Site
Avellino
Research Site
Bari
Research Site
Bergamo
Research Site
Brescia
Research Site
Cagliari
Research Site
Catania
Research Site
Catanzaro
Research Site
Cittadella (PD), Padova
Research Site
Civitanova Marche
Research Site
Ferrara
Research Site
Foggia
Research Site
Garbagnate(MI)
Research Site
Genova
Research Site
Lamezia Terme
Research Site
Massa Carrara
Research Site
Milan
Research Site
Modena
Research Site
Montebelluna (TV), TV
Research Site
Naples
Research Site
Orbassano (TO)
Research Site
Padova
Research Site
Reggio Emilia
Research Site
Roma
Research Site
Sassari
Research Site
Torino
Research Site
Tradate (VA)
Research Site
Verona
About this study
Official title: 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
Read the 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.
- Conditions
- Asthma
- Being tested
- Tezepelumab
- Keywords
- Asthma, uncontrolled severe asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Tezepelumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic and Clinic characterization
To describe demographic and clinical characteristics of a population of patients with severe asthma who initiated treatment with tezepelumab
Measured: 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
Measured: Basal
Secondary outcomes (13)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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].
Measured: 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start25 Jun 2025
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06948396
- Sponsor's protocol ID
- D5180R00031
- Acronym
- FRONTEDGE
- Status last verified
- Jul 2026
- First submitted
- 9 Apr 2025
- Last updated
- 20 Jul 2026
- Results posted
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IdentiFy attRibutes Of uNcontrolled Severe asThma Patients trEateD With Tezepelumab: Italian Clinical Practice Study With the New bioloGic targEting TSLP
- ClinicalTrials.gov ID
- NCT06948396
- Acronym / sponsor ID
- FRONTEDGE / D5180R00031
- Conditions
- Asthma
- Keywords
- Asthma, uncontrolled severe asthma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 315 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe uncontrolled asthma patients | – | Biological: TezepelumabAdolescent 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. |
Who may qualify
- Ages
- 12 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TezepelumabTezepelumab 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 | Biological | Severe uncontrolled asthma patients |
Primary outcome
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
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
13 secondary outcomes
Exacerbation rate
Time frame: Basal, 12 months, 24 months
mOCS (maintenance Oral Corticosteroids) and ICS (Inhaled Corticosteroids) use
Time frame: Basal, 12 months, 24 months
ACT (Asthma Control Test) score
Time frame: Basal, 12 months, 24 months
Asthma Control Questionnaire (ACQ) score
Time frame: Basal, 12 months, 24 months
Lung function FEV1 (L)
Time frame: Basal, 12 months, 24 months
Lung function FVC (L)
Time frame: Basal, 12 months, 24 months
Lung function % predicted FVC
Time frame: Basal, 12 months, 24 months
Lung function % predicted FEV1
Time frame: Basal, 12 months, 24 months
Biomarkers - BEC (blood eosinophils count)
Time frame: Basal, 12 months, 24 months
Biomarkers - FeNO (Fractional exhaled Nitric Oxide)
Time frame: Basal, 12 months, 24 months
Biomarkers - IgE (Immunoglobulin E)
Time frame: Basal, 12 months, 24 months
Treatments
Time frame: Basal, 12 months, 24 months
Clinical Remission
Time frame: 12 months, 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by AstraZeneca at 28 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic and Clinic characterization (time frame: Basal). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.