Severe AsthmaELBRUSNCT06566885
Real-world Study Assessing Efficacy of TezepeLumaB in Patients With Severe Asthma Regardless of Phenotype in Russia
An observational study of Severe Asthma, run by AstraZeneca at 15 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Severe Asthma
- How many people
- 125 participants
- Where
- 15 sitesRussia
- Study dates
- 10 Sep 2024to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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).
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Russia15 sites
Research Site
Kaliningrad
Research Site
Kemerovo
Research Site
Krasnodar
Research Site
Moscow
Research Site
Nal'chik
Research Site
Nizhny Novgorod
Research Site
Novosibirsk
Research Site
Orenburg
Research Site
Petrozavodsk
Research Site
Saint Petersburg
Research Site
Shelehov
Research Site
Stavropol
Research Site
Tomsk
Research Site
Ulan-Ude
Research Site
Yekaterinburg
About this study
Official title: 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
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.
Read the 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
- Keywords
- tezepelumab, severe asthma
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 1 year
Secondary outcomes (35)
1. ACQ-5 score at different points of time
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".
Measured: 1 year
2. Proportion of participants with well-controlled asthma
(ACQ-5 score ≤ 0.75) overall during the study and at different points of time [time points to measure: baseline and at Weeks 4, 12, 24 and 52 following tezepelumab initiation]
Measured: 1 year
3. Proportion of participants with ACQ-5 response
(reduction of ≥ 0.5 in score from baseline) overall during the study and at different points of time [time points to measure: baseline and at Weeks 4, 12, 24 and 52 following tezepelumab initiation]
Measured: 1 year
4. Median time to ACQ-5 response
(reduction of ≥ 0.5 in score from baseline), weeks [time points to measure: baseline and at Weeks 4, 12, 24 and 52 following
Measured: 1 year
8. Pre- and post-bronchodilator forced expiratory volume in 1 second
(FEV1) [time points to measure: baseline and at Weeks 4, 12, 24 and 52 following tezepelumab initiation]
Measured: 2 years
9. Pre- and post-bronchodilator forced vital capacity
(FVC) [time points to measure: baseline and at Weeks 4, 12, 24 and 52 following tezepelumab initiation]
Measured: baseline and at Weeks 4, 12, 24 and 52 following tezepelumab initiation
10. Pre-bronchodilator forced expiratory flow
(FEF) [time points to measure: baseline and at Weeks 4, 12, 24 and 52 following tezepelumab initiation]
Measured: baseline and at Weeks 4, 12, 24 and 52 following tezepelumab initiation
11. Changes on pre- and post-bronchodilator FEV1 from baseline
time points to measure: baseline and at Weeks 4, 12, 24 and 52 following tezepelumab initiation.
Forced expiratory volume in 1 second (FEV1) response is defined as achievement of either a ≥ 5% or ≥ 100 mL improvement from baseline
Measured: baseline and at Weeks 4, 12, 24 and 52 following tezepelumab initiation
12. Proportion of pre- and post-bronchodilator FEV1 responders
(defined as participants who achieved either a ≥ 5% or ≥ 100 mL improvement from baseline) overall during the study and at different points of time [time points to measure: baseline and at Weeks 4, 12, 24 and 52 following tezepelumab initiation];
Measured: 1 year
13. FRC
Functional residual capacity (FRC) evaluated by spirometry and/or body plethysmography (if available) [time points to measure: baseline and at Weeks 4, 12, 24 and 52 following tezepelumab initiation]. Units of measurement: % predicted and L.
Measured: 1 year
14. Annualised rate of severe asthma exacerbations
[time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation]
Measured: 2 years
15. Proportion of participants with reduced total number of severe asthma exacerbations at Week 52 following tezepelumab initiation compared with baseline
[time points to measure: baseline during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation]:
- Proportion of participants with any reduction in severe exacerbations number;
Measured: baseline during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
16. Change in annualised rate of severe asthma exacerbations from the baseline period to the follow-up period after tezepelumab initiation
[time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation]
Measured: baseline during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
17. Proportion of participants with 0, 1, 2, ≥3 severe asthma exacerbations
[time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation]
Measured: baseline during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
18. Cumulative days of severe asthma exacerbations
(calculated in participants who had severe asthma exacerbations at baseline) [time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation]
Measured: baseline during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
19. Proportion of participants with any SCS use
('systemic' means oral, parenteral CS) [time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation]
Measured: baseline during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
20. Proportion of participants with any reduction (≥ 25%, ≥ 50%, ≥ 75%, and 100% reduction) from baseline on cumulative SCS dose
(in prednisone equivalent dose) (to be calculated in participants with SCS use at baseline) [time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation]
Measured: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
21. Change in median SCS dose from baseline
(to be calculated in participants with SCS use at baseline) [time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation]
Measured: baseline during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
22. Proportion of participants with long-term (>30 consecutive days) SCS use
(to be calculated in participants with SCS use at baseline) [time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation]
Measured: baseline during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
23. Number (proportion) of participants with asthma-related healthcare resource utilisation
(by each type) [time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation]
Measured: baseline during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
24. Annualised rates of asthma-related hospitalisation, emergency calls (or emergency department visits), and unscheduled out-patient visits to a physician
[time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation];
Measured: baseline during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
25. Annualised rates of asthma-related scheduled physician visits or healthcare calls for asthma
[time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation]
Measured: baseline during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
26. Median overall duration (days) of asthma-related hospitalisations
[time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation].
Measured: baseline during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
27. Mean and median duration (days) of treatment with tezepelumab
to be calculated in all enrolled participants
Measured: Week 52
28. Median time (days) to tezepelumab discontinuation
to be calculated in participants who discontinued tezepelumab earlier than Week 52 by any reason
Measured: Week 52
29. Proportion of participants discontinued tezepelumab and switched to other biologic drug for asthma treatment and reason(s)
Measured: Week 52
8.2 Changes on pre- and post-bronchodilator FVC from baseline
Forced Vital Capacity (FVC) (L): both pre-bronchodilator and post-bronchodilator should be recorded. time points to measure: baseline and at Weeks 4, 12, 24 and 52 following tezepelumab initiation
Measured: baseline and at Weeks 4, 12, 24 and 52 following tezepelumab initiation
8.3 Changes on pre-bronchodilator FEF from baseline
Pre-bronchodilator forced expiratory flow (FEF) 25-75 - the mean speed of flow during forced expiration of from 25% to 75% of the FVC. Measured in L/sec. time points to measure: baseline and at Weeks 4, 12, 24 and 52 following tezepelumab initiation
Measured: baseline and at Weeks 4, 12, 24 and 52 following tezepelumab initiation
12.b Proportion of participants with reduced total number of severe asthma exacerbations at Week 52 following tezepelumab initiation compared with baseline
[time points to measure: baseline during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation]: Proportion of participants with at least 50% reduction in severe exacerbations number;
Measured: up to 2 years
12.c Proportion of participants with reduced total number of severe asthma exacerbations at Week 52 following tezepelumab initiation compared with baseline
[time points to measure: baseline during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation]: c. Proportion of participants who completed 52 weeks of tezepelumab treatment without any severe asthma exacerbation
Measured: 2 years
10.2 RLV
Residual lung volume (RLV) evaluated by spirometry and/or body plethysmography (if available) [time points to measure: baseline and at Weeks 4, 12, 24 and 52 following tezepelumab initiation]. Units of measurement: % predicted and L.
Measured: 1 year
10.3 TLC
Total lung capacity (TLC) evaluated by spirometry and/or body plethysmography (if available) [time points to measure: baseline and at Weeks 4, 12, 24 and 52 following tezepelumab initiation]. Units of measurement: % predicted and L.
Measured: 1 year
5. SNOT-22 questionnaire score
- SNOT-22 questionnaire score in patients with comorbid chronic rhinosinusitis with nasal polyps (rhinosinusitis polyposis) at different points of time
Measured: baseline and at Weeks 4, 12, 24, and 52 following tezepelumab initiation
6. Proportion of participants with clinically meaningful improvement
Proportion of participants with clinically meaningful improvement (reduction in SNOT-22 score by ≥ 8.9) overall during the study and at different points of time
Measured: baseline and at Weeks 4, 12, 24, and 52 following tezepelumab initiation
7. Median time to SNOT-22 response
Median time to SNOT-22 response (reduction of ≥8.9 in score from baseline), weeks [time points to measure
Measured: baseline and at Weeks 4, 12, 24, and 52 following tezepelumab initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start10 Sep 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566885
- Sponsor's protocol ID
- D5180R00029
- Acronym
- ELBRUS
- Status last verified
- Aug 2026
- First submitted
- 17 Jun 2024
- Last updated
- 28 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06566885
- Acronym / sponsor ID
- ELBRUS / D5180R00029
- Conditions
- Severe Asthma
- Keywords
- tezepelumab, severe asthma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 125 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (11 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in ACQ-5 score from baseline
Time frame: 1 year
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".
35 secondary outcomes
1. ACQ-5 score at different points of time
Time frame: 1 year
2. Proportion of participants with well-controlled asthma
Time frame: 1 year
3. Proportion of participants with ACQ-5 response
Time frame: 1 year
4. Median time to ACQ-5 response
Time frame: 1 year
8. Pre- and post-bronchodilator forced expiratory volume in 1 second
Time frame: 2 years
9. Pre- and post-bronchodilator forced vital capacity
Time frame: baseline and at Weeks 4, 12, 24 and 52 following tezepelumab initiation
10. Pre-bronchodilator forced expiratory flow
Time frame: baseline and at Weeks 4, 12, 24 and 52 following tezepelumab initiation
11. Changes on pre- and post-bronchodilator FEV1 from baseline
Time frame: baseline and at Weeks 4, 12, 24 and 52 following tezepelumab initiation
12. Proportion of pre- and post-bronchodilator FEV1 responders
Time frame: 1 year
13. FRC
Time frame: 1 year
14. Annualised rate of severe asthma exacerbations
Time frame: 2 years
15. Proportion of participants with reduced total number of severe asthma exacerbations at Week 52 following tezepelumab initiation compared with baseline
Time frame: baseline during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
16. Change in annualised rate of severe asthma exacerbations from the baseline period to the follow-up period after tezepelumab initiation
Time frame: baseline during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
17. Proportion of participants with 0, 1, 2, ≥3 severe asthma exacerbations
Time frame: baseline during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
18. Cumulative days of severe asthma exacerbations
Time frame: baseline during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
19. Proportion of participants with any SCS use
Time frame: baseline during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
20. Proportion of participants with any reduction (≥ 25%, ≥ 50%, ≥ 75%, and 100% reduction) from baseline on cumulative SCS dose
Time frame: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
21. Change in median SCS dose from baseline
Time frame: baseline during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
22. Proportion of participants with long-term (>30 consecutive days) SCS use
Time frame: baseline during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
23. Number (proportion) of participants with asthma-related healthcare resource utilisation
Time frame: baseline during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
24. Annualised rates of asthma-related hospitalisation, emergency calls (or emergency department visits), and unscheduled out-patient visits to a physician
Time frame: baseline during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
25. Annualised rates of asthma-related scheduled physician visits or healthcare calls for asthma
Time frame: baseline during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
26. Median overall duration (days) of asthma-related hospitalisations
Time frame: baseline during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
27. Mean and median duration (days) of treatment with tezepelumab
Time frame: Week 52
28. Median time (days) to tezepelumab discontinuation
Time frame: Week 52
29. Proportion of participants discontinued tezepelumab and switched to other biologic drug for asthma treatment and reason(s)
Time frame: Week 52
8.2 Changes on pre- and post-bronchodilator FVC from baseline
Time frame: baseline and at Weeks 4, 12, 24 and 52 following tezepelumab initiation
8.3 Changes on pre-bronchodilator FEF from baseline
Time frame: baseline and at Weeks 4, 12, 24 and 52 following tezepelumab initiation
12.b Proportion of participants with reduced total number of severe asthma exacerbations at Week 52 following tezepelumab initiation compared with baseline
Time frame: up to 2 years
12.c Proportion of participants with reduced total number of severe asthma exacerbations at Week 52 following tezepelumab initiation compared with baseline
Time frame: 2 years
10.2 RLV
Time frame: 1 year
10.3 TLC
Time frame: 1 year
5. SNOT-22 questionnaire score
Time frame: baseline and at Weeks 4, 12, 24, and 52 following tezepelumab initiation
6. Proportion of participants with clinically meaningful improvement
Time frame: baseline and at Weeks 4, 12, 24, and 52 following tezepelumab initiation
7. Median time to SNOT-22 response
Time frame: baseline and at Weeks 4, 12, 24, and 52 following tezepelumab initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Asthma, run by AstraZeneca at 15 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ACQ-5 score from baseline (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.