Home › Trials › NCT06566885

Assessing the effectiveness of tezepelumab for severe asthma 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

AstraZeneca · NCT06566885

This study is testing if the asthma medication tezepelumab can help people with severe asthma in Russia feel better over a year.

Quick facts

Study typeObservational
Enrollment110 (estimated)
Ages12 Years and up
SexAll
SponsorAstraZeneca (industry)
Drugs / interventionstezepelumab, immunotherapy
Locations13 sites (Ekaterinburg and 12 other locations)
Trial IDNCT06566885 on ClinicalTrials.gov

What this trial studies

This observational study, known as ELBRUS, will evaluate patient-reported outcomes in individuals with severe asthma who are starting treatment with tezepelumab in Russia. It will involve approximately 110 participants aged 12 years and older across 20 sites, collecting both primary and secondary data over a 12-month period. The treatment decision will be made independently by physicians based on established guidelines, and participants will continue their existing asthma therapies throughout the study. The study aims to gather real-world evidence on the efficacy of tezepelumab in this patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 12 years or older with a diagnosis of severe asthma who are eligible for tezepelumab treatment.

Not a fit: Patients with asthma not requiring tezepelumab or those with alternative diagnoses 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 for managing severe asthma.

How similar studies have performed: Other studies have shown success with tezepelumab in treating severe asthma, indicating a promising approach.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Ekaterinburg and 12 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Severe Asthma, tezepelumab, severe asthma

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.