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

NCT06566885 | Active Not Recruiting

• 1 other identifier: D5180R00029
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Severe Asthma

Keywords

tezepelumab; severe asthma

Outcome Measures

Primary Outcomes (1)

• Change in ACQ-5 score from baseline

  time points to measure: baseline and at Weeks 4, 12, 24 and 52 following tezepelumab initiation. Each question of the Asthma Control Questionnaire-5 is ranged on a 7-point scale from 0 (no impairment) to 6 (maximum impairment). The questions are equally weighted and the ACQ score is the mean of the all questions. The total score of ≥1.5 indicates a high probability that asthma is "poorly controlled", 0-0.75 - that asthma is "well controlled", and 0.75-1.5 is a "grey zone".

  1 year

Secondary Outcomes (35)

• 1. ACQ-5 score at different points of time

  1 year

• 2. Proportion of participants with well-controlled asthma

  1 year

• 3. Proportion of participants with ACQ-5 response

  1 year

• 4. Median time to ACQ-5 response

  1 year

• 8. Pre- and post-bronchodilator forced expiratory volume in 1 second

  2 years

Other Outcomes (14)

• 1. Median time from index date to lung function response by FEV1

  1 year

• 2. Proportion of participants with sustained (12 weeks or longer) response by FEV1

  1 year

• 3. Median time from index date to spirometry and/or body plethysmography response

  1 year

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants of both sexes, aged 12 years or older with severe uncontrolled asthma despite medium or high doses of ICS, who have commenced/will commence treatment with tezepelumab as determined by their routine clinical care. The study population is planned to comprise approximately 110 participants in approximately 20 sites. Eligible patients will be enrolled consecutively at each site to minimize selection bias at each site

You may qualify if:

• be eligible for enrolment into this study if all of the following criteria are met:
• Male or female participants aged 12 years or older at the time of signing the ICF or assent.
• Prescribed and initiated treatment with tezepelumab according to SmPC and local market reimbursement criteria. A period between treatment initiation and enrolment should be no more than 4 weeks.
• 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.
• 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).
• 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).
• 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.
• Individuals with ACQ-5 score ≥ 1.5 (indicating inadequate asthma symptom control) at enrolment or up to 12 weeks before enrolment.
• Currently receive care from specialist physicians (e.g., pulmonologists and/or allergists) at the Investigator's or sub-Investigator's site.
• Provision of signed and dated written informed consent, including assent (informed consent for participants under 18 years old).
• Participants are able to read, understand and complete the questionnaires required by the protocol.

You may not qualify if:

• Any contraindication to tezepelumab as per the approved product SmPC in Russia or in the opinion of the Investigator.
• 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.
• 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.
• Pregnancy or lactation period.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (15)

Research Site

Kaliningrad, Russia

Location

Research Site

Kemerovo, Russia

Location

Research Site

Krasnodar, Russia

Location

Research Site

Moscow, Russia

Location

Research Site

Nal'chik, Russia

Location

Research Site

Nizhny Novgorod, Russia

Location

Research Site

Novosibirsk, Russia

Location

Research Site

Orenburg, Russia

Location

Research Site

Petrozavodsk, Russia

Location

Research Site

Saint Petersburg, Russia

Location

Research Site

Shelehov, Russia

Location

Research Site

Stavropol, Russia

Location

Research Site

Tomsk, Russia

Location

Research Site

Ulan-Ude, Russia

Location

Research Site

Yekaterinburg, Russia

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: August 22, 2024
• Study Start: September 10, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

RU (15)