Real-life use of tezepelumab for severe asthma in Greece

The EVOLVE Study: A Prospective, Observational Study to Evaluate Patient-centered Outcomes Over 2 Years of Treatment With Tezepelumab in Real-life Clinical Practice in Greece

This study is testing how well tezepelumab works for adults with severe asthma in Greece who are starting this treatment for the first time or switching from another medication.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 12 Years and up
• Sex: All
• Sponsor: AstraZeneca (industry)
• Drugs / interventions: tezepelumab, immunotherapy
• Locations: 12 sites (Alexandroupoli and 11 other locations)
• Trial ID: NCT06724575 on ClinicalTrials.gov

What this trial studies

The EVOLVE study is an observational study aimed at gathering real-world evidence on the effectiveness of tezepelumab, a monoclonal antibody for uncontrolled severe asthma, over a two-year period. It will enroll 150 adult patients who have been newly prescribed tezepelumab, focusing on patient-reported outcomes and treatment effectiveness in routine care settings across Greece. The study will assess both Type 2-high and Type 2-low asthma patients, as well as those who are biologic naïve or switching from a prior biologic treatment.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 12 years or older with a diagnosis of asthma who have been prescribed tezepelumab but have not yet started treatment.

Not a fit: Patients who do not have a documented history of asthma exacerbations or those whose asthma symptoms are controlled may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness of tezepelumab, potentially improving treatment decisions for patients with severe asthma.

How similar studies have performed: Other studies have shown success with similar approaches in gathering real-world data for asthma treatments, making this study a valuable addition to existing knowledge.

Eligibility criteria

Inclusion Criteria:

* Male or female outpatients aged 12 years or older at the time of signing the informed consent/assent form.
* Patients who have been prescribed but not yet initiated treatment with tezepelumab according to the label and local market reimbursement criteria.
* Diagnosis of asthma for at least 52 weeks prior to enrolment date and symptoms confirmed by the Investigator not to be due to alternative diagnoses.
* Receipt of at least one prescription of high-dose Inhaled Corticosteroids (ICS) (according to the Global Initiative for Asthma 2024) during the 52 weeks prior to enrolment date.
* Use of additional asthma maintenance controller medication(s) in addition to ICS either as free- or fixed-drug combination for at least 52 weeks prior to enrolment date.
* Documented history of at least 1 asthma exacerbation during the 52 weeks prior to enrolment date.
* Asthma Control Questionnaire (ACQ-6) score ≥1.5 (indicating inadequate asthma symptom control) at enrolment.
* Availability of at least one Blood Eosinophil Count (BEC) measurement (in medical records) in the 52-week period prior to enrolment date.
* Availability of participants' medical records for asthma exacerbations and unscheduled Health Care Resource Utilization (HCRU) for the 52 weeks prior to enrolment date.
* Patients are able to understand and complete the Patient-Reported Outcome (PROs).
* Provision of signed and dated written informed consent/assent (as applicable).

Exclusion Criteria:

* Any contraindication to tezepelumab as per the approved product label or in the opinion of the Investigator.
* Concurrent or recent (\<30 days before the index date) treatment with biologics for asthma, with the exception of stable allergen immunotherapy (defined as a stable dose and regimen at the time of enrolment).
* Participation in an observational study that might, in the Investigator's opinion, influence the assessment for the current study, or participation in an interventional clinical trial in the last 3 months.
* Currently pregnant (or intention to become pregnant) or lactating women.

Where this trial is running

Alexandroupoli and 11 other locations

• Research Site — Alexandroupoli, Greece (RECRUITING)
• Research Site — Athens, Greece (RECRUITING)
• Research Site — Athens, Greece (WITHDRAWN)
• Research Site — Athens, Greece (NOT_YET_RECRUITING)
• Research Site — Corfu, Greece (RECRUITING)
• Research Site — Crete, Greece (RECRUITING)
• Research Site — Ioannina, Greece (RECRUITING)
• Research Site — Larisa, Greece (RECRUITING)
• Research Site — Patra, Greece (NOT_YET_RECRUITING)
• Research Site — Patra, Greece (RECRUITING)
• Research Site — Thessaloniki, Greece (RECRUITING)
• Research Site — Thessaloniki, Greece (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions: Asthma, severe asthma, tezepelumab, real world data, patient reported outcomes, Greece