Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 1. Change in endoscopic status of CRSwNP based on NPS | Change in NPS score from baseline | 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 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 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 points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | Kazan' | Russia | |||
| Research Site |
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.
Not provided
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.
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.
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
| 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 points to measure: Week 52/End of Study |
| 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 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 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 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 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 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 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 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 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 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. | 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 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 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 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 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 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 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 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 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 points to measure: from the date of CRSwNP diagnosis and up to 52 weeks following tezepelumab initiation |
| Not yet recruiting |
| Kemerovo |
| Russia |
| Research Site | Recruiting | Krasnoyarsk | Russia |
| Research Site | Recruiting | Moscow | Russia |
| Research Site | Not yet recruiting | Moscow | Russia |
| Research Site | Recruiting | Rostov-on-Don | Russia |
| Research Site | Recruiting | Ryazan | Russia |
| Research Site | Recruiting | Saint-Petesburg | Russia |
| Research Site | Not yet recruiting | Saint-Petesburg | Russia |
| Research Site | Recruiting | Ulyanovsk | Russia |
| Research Site | Recruiting | Yekaterinburg | Russia |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |