Real-world Study Assessing Efficacy of TezepeLumaB in Patients With Severe Asthma Regardless of Phenotype in Russia
NCT Number: NCT06566885
Acronym: ELBRUS
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Severe Asthma
Sponsor: AstraZeneca
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 110
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-10
Completion Date: 2025-06-30
Locations: Research Site, Novosibirsk, Russian Federation

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.

Primary Outcome Measures: 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 Outcome Measures: 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"., 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 \[time points to measure: baseline and at Weeks 4, 12, 24 and 52 following tezepelumab initiation\], 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 \[time points to measure: baseline and at Weeks 4, 12, 24 and 52 following tezepelumab initiation\], 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, 1 year|5. Pre- and post-bronchodilator forced expiratory volume in 1 second, (FEV1) \[time points to measure: baseline and at Weeks 4, 12, 24 and 52 following tezepelumab initiation\], 2 years|6. Pre- and post-bronchodilator forced vital capacity, (FVC) \[time points to measure: baseline and at Weeks 4, 12, 24 and 52 following tezepelumab initiation\], baseline and at Weeks 4, 12, 24 and 52 following tezepelumab initiation|7. Pre-bronchodilator forced expiratory flow, (FEF) \[time points to measure: baseline and at Weeks 4, 12, 24 and 52 following tezepelumab initiation\], baseline and at Weeks 4, 12, 24 and 52 following tezepelumab initiation|8.1 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, baseline and at Weeks 4, 12, 24 and 52 following tezepelumab initiation|9. 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 \[time points to measure: baseline and at Weeks 4, 12, 24 and 52 following tezepelumab initiation\];, 1 year|10.1 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., 1 year|11. Annualised rate of severe asthma exacerbations, \[time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation\], 2 years|12.a Proportion of participants with reduced total number of severe asthma exacerbations at Week 52 following tezepelumab initiation compared with baseline, \[time points to measure: baseline during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation\]:

a. Proportion of participants with any reduction in severe exacerbations number;, baseline during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation|13. Change in annualised rate of severe asthma exacerbations from the baseline period to the follow-up period after tezepelumab initiation, \[time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation\], baseline during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation|14. Proportion of participants with 0, 1, 2, ≥3 severe asthma exacerbations, \[time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation\], baseline during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation|15. Cumulative days of severe asthma exacerbations, (calculated in participants who had severe asthma exacerbations at baseline) \[time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation\], baseline during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation|16. Proportion of participants with any SCS use, ('systemic' means oral, parenteral CS) \[time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation\], baseline during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation|17. 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) \[time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation\], during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation|18. Change in median SCS dose from baseline, (to be calculated in participants with SCS use at baseline) \[time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation\], baseline during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation|19. Proportion of participants with long-term (>30 consecutive days) SCS use, (to be calculated in participants with SCS use at baseline) \[time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation\], baseline during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation|20. Number (proportion) of participants with asthma-related healthcare resource utilisation, (by each type) \[time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation\], baseline during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation|21. Annualised rates of asthma-related hospitalisation, emergency calls (or emergency department visits), and unscheduled out-patient visits to a physician, \[time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation\];, baseline during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation|22. Annualised rates of asthma-related scheduled physician visits or healthcare calls for asthma, \[time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation\], baseline during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation|23. Median overall duration (days) of asthma-related hospitalisations, \[time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation\]., baseline during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation|24. Mean and median duration (days) of treatment with tezepelumab, to be calculated in all enrolled participants, Week 52|26. Median time (days) to tezepelumab discontinuation, to be calculated in participants who discontinued tezepelumab earlier than Week 52 by any reason, Week 52|27. Proportion of participants discontinued tezepelumab and switched to other biologic drug for asthma treatment and reason(s), 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, 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, 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;, 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, 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., 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., 1 year
Other Outcome Measures: 1.1 Median time from index date to lung function response by FEV1, (FEV1 response is defined as achievement of either a ≥ 5% or ≥ 100 mL improvement from baseline) \[time points to measure: baseline and at Weeks 12, 24 and 52 following tezepelumab initiation\], 1 year|2. Proportion of participants with sustained (12 weeks or longer) response by FEV1, \[time points to measure: baseline and at Weeks 12, 24 and 52 following tezepelumab initiation\], 1 year|3.1 Median time from index date to spirometry and/or body plethysmography response, (spirometry and/or body plethysmography response is defined as achievement of a ≥ 5% improvement from baseline) \[time points to measure: baseline and at Weeks 12, 24 and 52 following tezepelumab initiation\];, 1 year|4. Proportion of participants with sustained (12 weeks or longer) spirometry and/or body plethysmography response, \[time points to measure: baseline and at Weeks 12, 24 and 52 following tezepelumab initiation\], 1 year|5. Proportion of participants with medications for asthma treatment by drug class, \[time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation\], 2 years|6. Cumulative dose of ICS by each ICS medication, (ICS may be contained in a single-component product and a combination product, e.g., ICS/LABA) \[time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation\], 2 years|7. Medication possession ratio (MPR), total days' supply of a medication in a particular time period, divided by the number of days in the time period, Week 52|8. SNOT-22 total score, \[time points to measure: baseline and at Weeks 4, 12, 24 and 52 following tezepelumab initiation\] The Sinonasal Outcome Test 22 (SNOT-22) comprises 22 items, each scored from 0 (no problem) to 5 (problem as bad as can be). The total SNOT score is calculated as the sum of the score for all items, even if the participant fails to answer all items., 1 year|9. Change on SNOT-22 total score from baseline, \[time points to measure: baseline and at Weeks 4, 12, 24 and 52 following tezepelumab initiation\] The Sinonasal Outcome Test 22 (SNOT-22) comprises 22 items, each scored from 0 (no problem) to 5 (problem as bad as can be). The total SNOT score is calculated as the sum of the score for all items, even if the participant fails to answer all items., 1 year|10. Proportion of SNOT-22 responders (improvement of ≥ 8.9 in SNOT-22 total 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. The Sinonasal Outcome Test 22 (SNOT-22) comprises 22 items, each scored from 0 (no problem) to 5 (problem as bad as can be). The total SNOT score is calculated as the sum of the score for all items, even if the participant fails to answer all items., 1 year|11. A patient's body weight (kg) measured in participants with elevated BMI at enrolment, (≥25 mg/m2) \[time points to measure: baseline and at Weeks 4, 12, 24 and 52 following tezepelumab initiation\];, 1 year|12. Change in body weight from baseline calculated in participants with elevated BMI at enrolment, (≥25 mg/m2) \[time points to measure: baseline and at Weeks 4, 12, 24 and 52 following tezepelumab initiation\]., 1 year|13. Number and proportion of participants who achieved asthma clinical remission at Week 52, Week 52|1.2 Median duration of lung function response by FEV1 from index date, time points to measure: baseline and at Weeks 12, 24 and 52 following tezepelumab initiation, 1 year|3.2 Median duration of spirometry and/or body plethysmography response from index date (if available), (spirometry and/or body plethysmography response is defined as achievement of a ≥ 5% improvement from baseline) \[time points to measure: baseline and at Weeks 12, 24 and 52 following tezepelumab initiation\];, 1 year