Real-world Study Assessing Efficacy of TezepeLumaB in Patients With Severe Asthma Regardless of Phenotype in Russia

Launched by ASTRAZENECA · Aug 20, 2024

Keywords

ClinConnect Summary

The ELBRUS trial is a research study looking at how effective a medication called tezepelumab is for people with severe asthma in Russia. This study will last for 12 months and will gather information based on the experiences and feedback of patients after they start using tezepelumab. It's important to note that this trial is observational, meaning that researchers will observe and collect data without changing how patients typically receive care.

To be eligible for this study, participants need to be at least 12 years old and have had a diagnosis of asthma for at least a year. They should have been prescribed tezepelumab and have a history of asthma symptoms that weren't well controlled, as well as experiencing severe asthma attacks in the past year. Participants will work closely with their doctors and complete questionnaires to help researchers understand how well the treatment is working for them. If you or someone you know has severe asthma and meets these criteria, participating in this study could provide valuable insights into managing the condition.

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Eligibility criteria

• Inclusion Criteria:
• be eligible for enrolment into this study if all of the following criteria are met:
• • 1. Male or female participants aged 12 years or older at the time of signing the ICF or assent.
• • 2. Prescribed treatment with tezepelumab according to SmPC and local market reimbursement criteria. If a patient is enrolled to the study after tezepelumab initiation, a period between treatment initiation and enrolment should be no more than 4 weeks.
• • 3. Diagnosis of asthma established for at least 52 weeks prior to tezepelumab initiation and symptoms confirmed by the Investigator not to be due to alternative diagnoses.
• • 4. Received at least one prescription of medium or high doses of ICS during the 52 weeks prior to tezepelumab initiation, with medium or high doses of ICS defined according to the GINA 2022 (see below Note #1).
• • 5. Use of additional asthma maintenance controller medication(s) in addition to ICS (e.g., LABA, leukotriene receptor inhibitors, theophylline, LAMA, and cromones) for at least 52 weeks prior to tezepelumab initiation. The additional maintenance controller medication may be contained in a combination product (e.g., ICS/LABA).
• • 6. Documented history of at least 2 severe asthma exacerbations during the 52 weeks prior to tezepelumab initiation. For participants receiving prior biologic drugs for ≥ 8 months, at least 1 severe exacerbation must have occurred on prior biologic treatment. Participants are excluded if, in the opinion of the Investigator, prior biologic treatment had provided significant clinical benefit in the past 52 weeks, despite the participant experiencing ≥ 2 severe exacerbations during 52 weeks prior to tezepelumab initiation.
• • 7. Individuals with ACQ-5 score ≥ 1.5 (indicating inadequate asthma symptom control) at enrolment or up to 12 weeks before enrolment.
• • 8. Currently receive care from specialist physicians (e.g., pulmonologists and/or allergists) at the Investigator's or sub-Investigator's site.
• • 9. Provision of signed and dated written informed consent, including assent (informed consent for participants under 18 years old).
• • 10. Participants are able to read, understand and complete the questionnaires required by the protocol.
• Exclusion Criteria:
• • 1. Any contraindication to tezepelumab as per the approved product SmPC in Russia or in the opinion of the Investigator.
• • 2. Administration of concurrent biologic drug for asthma since the index date, except for stable allergen immunotherapy (defined as a stable dose and regimen at the time of enrolment). Enrolment of patients who were switched from other biologic(s) to tezepelumab is allowed, and an acceptable timeframe since the last prior asthma biologic drug is ≥ 30 days. The number of participants with prior biologic treatment (switching to tezepelumab) should be targeted at 20% or less at each site.
• • 3. 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.
• • 4. Pregnancy or lactation period.