NCT06566885

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

Multicentre, Single Arm, Non-interventional, Observational, Prospective Study to Assess Demographic Characteristics, Burden of Disease and Short-term Patient Reported Outcomes on Symptom Relief in Severe Asthma Patients Aged Older Than 12 Qualifying for Treatment With Tezepelumab in Russia

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 125 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

ELBRUS is a 12-month (52-week), multi-centre, prospective, non-comparative and non-interventional (observational), post-reimbursement real-world evidence study that will assess patient-reported outcomes after tezepelumab treatment initiation in participants with severe asthma in Russia.

Detailed description

This is a multi-centre, retrospective-prospective, non-comparative and non-interventional (observational) cohort study involving primary and secondary data collection within real-world settings of participants who initiate tezepelumab for treatment of severe uncontrolled asthma. Participants of the study will be the patients eligible for tezepelumab treatment based on the assessment in accordance with the approved product Summary of Product Characteristics (SmPC) in Russia. The administration of tezepelumab will be independent of this study (i.e., a decision of tezepelumab initiation is based on the physician's choice and regulatory and clinical features, not on recruitment/participation in the study). Tezepelumab is indicated as an add-on maintenance treatment for severe asthma, therefore, patients will continue background asthma therapy throughout the study, irrespective of their decision to participate in this study or not. Approximately 110 eligible participants of both sexes, aged 12 years or older will be treated with tezepelumab available in the market and according to the Russian reimbursement policies in approximately 20 sites. In eligible participants who agree to take part in the study, the enrolment date is defined as the date of informed consent or assent. After enrolment and evaluation of inclusion/exclusion criteria, study participants will commence tezepelumab treatment as per the physician's decision and following the local product SmPC. The index date is defined as the date when participants have received the first dose of tezepelumab. The enrolment period is the period between enrolment date and index date. Additionally, participants may be enrolled in this study up to 4 weeks after the first dose of tezepelumab, but no longer, to avoid responder bias. Participants will be followed for a maximum period of 52 weeks after index date, irrespective of treatment discontinuation. Patient-reported outcomes - the primary endpoint (ACQ-5) and SNOT-22 will be retrospectively collected during enrolment for all patients (i.e. the most recent available values in the 52 weeks prior to index date), and prospectively collected at suggested visits at Weeks 4, 12, 24, and 52 following index date. For patients who initiate treatment after being enrolled into the study the baseline value may be collected prospectively after enrolment before start of treatment. The baseline period is defined as the 52 weeks prior to the index date. Outcomes of interest, such as severe asthma exacerbations, medication use, and healthcare resource utilization, will be collected during enrolment retrospectively for the baseline period (52 weeks prior to the index date) and then prospectively at Weeks 4, 12, 24, and 52 following index date. Overall expected duration of the study (from the first patient inclusion to the last patient last visit) is about 2 years or until 110 eligible patients are included to the study and data on these patients are collected, whichever occurs first. As an observational, this study does not imply any intervention into a routine clinical practice, including choice of treatment modality or additional diagnostic methods.

Conditions

• Severe Asthma

Timeline

• Start date: 2024-09-10
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2024-08-22
• Last updated: 2026-02-05

Locations

15 sites across 1 country: Russia