An observational study in Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) and Asthma, sponsored by AstraZeneca. Recruiting at 10 sites in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by AstraZeneca · Observational
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Among 359 studies in Asthma by AstraZeneca — 19 open to participants now, 28 under way, 8 of them phase 3. Asthma · AstraZeneca.
Among the 359 studies in Asthma by AstraZeneca, this one is the 98th largest by planned enrollment of the 110 observational ones that give a count, is one of 13 that started in 2025, is one of 111 observational ones, reaches primary completion later than 18 of the 27 other live ones, and was the 349th registered.
4,846 studies on the registry are indexed under Asthma; 602 are open to participants now.
Browse Asthma studies →19 of the 359 studies in Asthma by AstraZeneca are open now, in 12 countries. Recruiting first, the newest first:
AstraZeneca · Sites in Korea, Republic of
AstraZeneca · Sites in China
AstraZeneca · Sites in United States, Argentina, Austria and 11 more countries
Ages 6+
AstraZeneca · Sites in China
Ages 18–75
AstraZeneca · Sites in United States, Argentina, Czechia and 4 more countries
Ages 4–11
By country, each count listing its studies:
Of the 417 Asthma studies recruiting now, 140 (34%) set no upper age limit and 205 (49%) stop at 75 or younger; 146 take children under 18; 104 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
359 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 46 · Phase 2 52 · Phase 3 123 · Phase 4 23
First in 1996; this study’s year is marked. 13 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 110 is below the median of 158 across 1,251 observational studies indexed under Asthma.
Median enrollment 175 across the 248 interventional studies, 500 across the 110 observational. Of the 330 that completed or were terminated, 129 (39%) have results posted.
This tab as a report to print or save as PDF → With an account.
AstraZeneca is the lead sponsor of 3,503 studies on the registry; 273 are open to participants now.
Of its 369 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
13 of the studies in Asthma by AstraZeneca that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05692180Phase 3AstraZenecaA Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma | 2026-12-23 |
| NCT06473779Phase 3AstraZenecaOpen-label Study to Assess Reduction of Background Asthma Medication While Sustaining Asthma Control and Clinical Remission With Tezepelumab in Patients 12-80yrs With Severe Asthma. | 2027-06-25 |
| NCT06471257Phase 3AstraZenecaA Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma | 2027-10-04 |
| NCT06307665Phase 3AstraZenecaEvaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma | 2027-10-13 |
| NCT07218172AstraZenecaCharacterization and Clinical Outcomes of Severe Asthma Patients in Israel Treated With Benralizumab (SAIL-B) | 2026-11-30 |
Add all 13 to your calendar (.ics) → With an account.
Among the 359 studies in Asthma by AstraZeneca, from their registry updates:
This tab as a report to print or save as PDF → With an account.
ARES 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 have initiated tezepelumab (no more than 4 weeks before inclusion) for treatment of CRSwNP (with or without comorbid asthma).
ARES 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 have initiated tezepelumab (no more than 4 weeks before inclusion) for treatment of CRSwNP (with or without comorbid asthma) to capture real-world data on the effectiveness and use patterns of tezepelumab outside the controlled conditions of a randomized clinical trial.
The study will be conducted in real-world setting at approximately 10 sites in the Russian Federation. A total of 110 eligible adult participants (aged ≥18 years) of both sexes who will be treated with tezepelumab as prescribed by their treating physicians will be enrolled.
Participants of both sexes aged 18 years and older with severe nasal polyposis (NPS ≥ 5) and the need for surgery, severe nasal congestion (Nasal Blockage ≥ 3 as part of SNOT-22), significant decrease in quality of life (SNOT-22 ≥ 30) despite the use of intranasal CS, who have indications for the prescription of biological therapy, who have commenced treatment with Tezepelumab as determined by their routine clinical care, will be enrolled in the otolaryngology setting of clinical institutions in Russia. Eligible patients will be enrolled consecutively at each site to minimize selection bias at each site. The study will target to enroll no more than 20% participants switching from a prior biologic drug to Tezepelumab and no more than 60% participants with comorbid asthma.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1. Change in endoscopic status of CRSwNP based on NPS
Change in NPS score from baseline
Time frame: time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation
2. Change in a nasal congestion status based on Nasal Blockage score as part of SNOT-22 (NBS-SNOT-22)
Change in Nasal blockage score as part of SNOT-22 (NBS-SNOT-22) from baseline
Time frame: time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation
3. Change in endoscopic status of CRSwNP based on NPS
Proportion of patients with at least a 1-point improvement in NPS score from baseline
Time frame: time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation
4. Change in a nasal congestion status based on Nasal Blockage score as part of SNOT-22 (NBS-SNOT-22)
Proportion of patients with at least a 1-point improvement in Nasal blockage score as part of SNOT-22 (NBS-SNOT-22) from baseline
Time frame: time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation
1. Change in SNOT-22 total score from baseline
To describe the participant-reported evaluation of the symptoms of CRSwNP using the Sinonasal Outcome Test-22 (SNOT-22) at baseline\* and up to 52 weeks following tezepelumab initiation.
Time frame: time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation
2. Proportion of participants with clinically meaningful change (reduction in SNOT-22 score by ≥ 8.9) from baseline
To describe the participant-reported evaluation of the symptoms of CRSwNP using the Sinonasal Outcome Test-22 (SNOT-22) at baseline\* and up to 52 weeks following tezepelumab initiation.
Time frame: To describe the participant-reported evaluation of the symptoms of CRSwNP using the Sinonasal Outcome Test-22 (SNOT-22) at baseline* and up to 52 weeks following tezepelumab initiation.
3. Change in loss of smell (as a part of SNOT-22) from baseline
To describe a smell status based on loss of smell score as part of SNOT-22 at baseline\* and up to 52 weeks following tezepelumab initiation.
Time frame: time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation
4. Proportion of patients with at least a 1-point change in loss of smell (as a part of SNOT-22) from baseline
To describe a smell status based on loss of smell score as part of SNOT-22 at baseline\* and up to 52 weeks following tezepelumab initiation.
Time frame: time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation
5. Change in Lund-Mackay score from baseline
To describe status of nasal cavity and paranasal sinuses using CT and Lund-Mackay score at baseline\* and up to 52 weeks following tezepelumab initiation.
Time frame: time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation
6. Change in ACQ-5 score from baseline
To describe asthma control questionnaire (ACQ-5) among participants with ongoing diagnosis of asthma
Time frame: time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation
7. Proportion of participants with ACQ-5 response (reduction of ≥ 0.5 in score from baseline)
To describe asthma control questionnaire (ACQ-5) among participants with ongoing diagnosis of asthma
Time frame: time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation
8. Number (proportion) of participants with CRSwNP-related healthcare resource utilisation (by each type)
To describe CRSwNP-related healthcare resource utilisation (HCRU)
Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
9. Annualised rates of CRSwNP-related hospitalisation, emergency calls (or emergency department visits), and unscheduled out-patient visits to a physician
To describe CRSwNP-related healthcare resource utilisation (HCRU)
Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
10. Annualised rates of CRSwNP-related scheduled physician visits or healthcare calls for CRSwNP
To describe CRSwNP-related healthcare resource utilisation (HCRU).
Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
11. Median overall duration (days) of CRSwNP-related hospitalisations
To describe CRSwNP-related healthcare resource utilisation (HCRU)
Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
12. Number (proportion) of participants with asthma-related healthcare resource utilisation (by each type)
To describe asthma-related HCRU among participants with ongoing diagnosis of asthma
Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
13. Annualised rates of asthma-related hospitalisation, emergency calls (or emergency department visits), and unscheduled out-patient visits to a physician
To describe asthma-related HCRU among participants with ongoing diagnosis of asthma
Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
14. Annualised rates of asthma-related scheduled physician visits or healthcare calls for asthma
To describe asthma-related HCRU among participants with ongoing diagnosis of asthma
Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
15. • Median overall duration (days) of asthma-related hospitalisations
To describe asthma-related HCRU among participants with ongoing diagnosis of asthma
Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
16. Annualised rate of CRSwNP exacerbations
To describe CRSwNP exacerbations.
Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
17. Change in annualised rate of CRSwNP exacerbations from the baseline period to the follow-up period after tezepelumab initiation
To describe CRSwNP exacerbations.
Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
18. Proportion of participants with 0, 1, 2, ≥3 CRSwNP exacerbations
To describe CRSwNP exacerbations.
Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
19. Cumulative days of CRSwNP exacerbations (calculated in participants who had CRSwNP exacerbations at baseline)
To describe CRSwNP exacerbations.
Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
20. Annualised rate of severe* asthma exacerbations
To describe severe asthma exacerbations among participants with ongoing diagnosis of asthma.
Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
21. Change in annualised rate of severe* asthma exacerbations from the baseline period to the follow-up period after tezepelumab initiation
To describe severe asthma exacerbations among participants with ongoing diagnosis of asthma.
Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
22. Proportion of participants with 0, 1, 2, ≥3 severe* asthma exacerbations
To describe severe asthma exacerbations among participants with ongoing diagnosis of asthma.
Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
23. Cumulative days of severe* asthma exacerbations (calculated in participants who had asthma exacerbations at baseline)
To describe severe asthma exacerbations among participants with ongoing diagnosis of asthma.
Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
24. Median duration (days) of treatment with tezepelumab (to be calculated in all enrolled participants)
To describe tezepelumab treatment features, including duration of therapy, in the 52 weeks following initiation of treatment.
Time frame: time points to measure: Week 52/End of Study
25. Proportion of participants with tezepelumab discontinuation overall and by reason
To describe tezepelumab treatment features, including duration of therapy, discontinuation, and reasons for discontinuation in the 52 weeks following initiation of treatment.
Time frame: time points to measure: Week 52/End of Study
26. • Median time (days) to tezepelumab discontinuation (to be calculated in participants who discontinued tezepelumab earlier than Week 52 by any reason)
To describe tezepelumab treatment features, including duration of therapy, discontinuation, and reasons for discontinuation in the 52 weeks following initiation of treatment.
Time frame: time points to measure: Week 52/End of Study
27. Proportion of participants discontinued tezepelumab and switched to other biologic drug for CRSwNP / asthma treatment and reason(s)
To describe duration of Tezepelumab therapy in the 52 weeks following initiation of treatment.
Time frame: time points to measure: Week 52/End of Study
28. Change in blood eosinophils level (cells/μL) from baseline
To describe biomarkers profile of participants and its dynamics from baseline\* and up to 52 weeks following tezepelumab initiation.
Time frame: time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation
29. Change in total IgE level (IU/mL) from baseline
To describe biomarkers profile of participants and its dynamics from baseline\* and up to 52 weeks following tezepelumab initiation.
Time frame: time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation
30. Mean duration (days) of treatment with tezepelumab (to be calculated in all enrolled participants)
To describe tezepelumab treatment features, including duration of therapy in the 52 weeks following initiation of treatment.
Time frame: time points to measure: Week 52/End of Study
31. Proportion of participants discontinued tezepelumab and switched to other biologic drug for CRSwNP / asthma treatment and reason(s)
To describe reasons for discontinuation in the 52 weeks following initiation of treatment.
Time frame: time points to measure: Week 52/End of Study
1. Proportion of participants with medications for CRSwNP treatment by drug class
To describe use of CRSwNP treatment (including surgery) at baseline\* and up to 52 weeks following tezepelumab initiation.
Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
2. Proportion of patients with InCS use
To describe use of CRSwNP treatment (including surgery) at baseline\* and up to 52 weeks following tezepelumab initiation.
Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
3. Mean daily dose of sCS (to be calculated in participants who used sCS)
To describe use of CRSwNP treatment (including surgery) at baseline\* and up to 52 weeks following tezepelumab initiation.
Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
4. Proportion of patients with oral antibiotics use due to CRSwNP or its exacerbation
To describe use of CRSwNP treatment (including surgery) at baseline\* and up to 52 weeks following tezepelumab initiation.
Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
5. Proportion of patients with any sCS use due to CRSwNP or its exacerbation ('systemic' means oral, parenteral CS)
To describe use of CRSwNP treatment (including surgery) at baseline\* and up to 52 weeks following tezepelumab initiation.
Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
6. Proportion of patients with 0, 1 and ≥2 courses of sCS due to CRSwNP or its exacerbation
To describe use of CRSwNP treatment (including surgery) at baseline\* and up to 52 weeks following tezepelumab initiation.
Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
7. Median number of sCS courses due to CRSwNP or its exacerbation
To describe use of CRSwNP treatment (including surgery) at baseline\* and up to 52 weeks following tezepelumab initiation.
Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
8. • Proportion of patients with any other biologic therapy use due to CRSwNP and/or severe asthma
To describe use of CRSwNP treatment (including surgery) at baseline\* and up to 52 weeks following tezepelumab initiation.
Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
9. 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
To describe use of CRSwNP treatment (including surgery) at baseline\* and up to 52 weeks following tezepelumab initiation.
Time frame: time points to measure: Week 52/End of Study
10. Proportion of participants with CRSwNP-related surgical interventions by type of surgery
To describe use of CRSwNP treatment (including surgery) at baseline\* and up to 52 weeks following tezepelumab initiation.
Time frame: time points to measure: from the date of CRSwNP diagnosis and up to 52 weeks following tezepelumab initiation
11. Median time since the most recent nasal polyp surgery, calculated at the date of tezepelumab initiation.
To describe use of CRSwNP treatment (including surgery) at baseline\* and up to 52 weeks following tezepelumab initiation.
Time frame: The date of tezepelumab initiation
12. Proportion of patients with 0, 1, 2, 3, 4 and ≥5 CRSwNP-related surgical interventions
To describe use of CRSwNP treatment (including surgery) at baseline\* and up to 52 weeks following tezepelumab initiation.
Time frame: time points to measure: from the date of CRSwNP diagnosis and up to 52 weeks following tezepelumab initiation
13. Median number of CRSwNP-related surgical interventions
To describe use of CRSwNP treatment (including surgery) at baseline\* and up to 52 weeks following tezepelumab initiation.
Time frame: time points to measure: from the date of CRSwNP diagnosis and up to 52 weeks following tezepelumab initiation
14. Proportion of patients with indications for CRSwNP-related surgery
To describe the need for sCS use and/or nasal polyp surgery during the tezepelumab treatment period (52 weeks).
Time frame: time points to measure: from the index date and up to 52 weeks following tezepelumab initiation
15. Proportion of patients with the need of sCS therapy
To describe the need for sCS use and/or nasal polyp surgery during the tezepelumab treatment period (52 weeks).
Time frame: time points to measure: from the index date and up to 52 weeks following tezepelumab initiation
16. Median time to first sCS use and/or nasal polyp surgery during the treatment period
To describe the need for sCS use and/or nasal polyp surgery during the tezepelumab treatment period (52 weeks).
Time frame: time points to measure: from the index date and up to 52 weeks following tezepelumab initiation
17. Patients' adherence to treatment, which will be calculated at the date of the corresponding visit as (actual number of injections received / planned number of injections prescribed by physician * 100%)
To describe participants' adherence to treatment up to 52 weeks following tezepelumab initiation.
Time frame: time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation
18. Proportion of participants with each category of PGI-S scale
To describe patient-reported impression of disease severity (PGI-S) scale
Time frame: time points to measure: baseline
19. • Proportion of participants with each category of PGI-C scale
To describe patient-reported impression of treatment using Patient Global Impression of Change (PGI-C) scale throughout the 52-week treatment period.
Time frame: time points to measure: Weeks 4, 24 and 52 following tezepelumab initiation
20. Proportion of participants with CRSwNP-related surgical interventions by volume of surgery
To describe use of CRSwNP treatment (including surgery) at baseline\* and up to 52 weeks following tezepelumab initiation.
Time frame: time points to measure: from the date of CRSwNP diagnosis and up to 52 weeks following tezepelumab initiation
Plan to share: 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.
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.
Data sharing details ↗ · vivli.org
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Started Dec 2025 (actual). Primary completion is estimated for Mar 2028, 27 months after the start.
Of 90 industry-sponsored observational studies under Asthma, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 58. This study's planned 27 months is close to that.
Counting every sponsor, half of 454 studies reached it within 36 months; a quarter within 18 and three quarters within 82.
How these figures are worked out, and which studies are left out of them.
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