ReAl-woRld Evaluation of tEzepelumab for Chronic rhinoSinusitis With Nasal Polyps in Russia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAstraZeneca
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female participants aged 18 years or older at the time of signing the ICF.
Diagnosis of CRSwNP established for at least 52 weeks prior to tezepelumab initiation.
Availability of participants' medical records for at least 52 weeks prior to tezepelumab initiation, including history of sCS use / nasal polyps surgery (or information about contraindications / intolerance to).
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.
Disqualifiers
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 CRSwNP / 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 biologic drug is ≥ 60 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 population
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.
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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 initiation2
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 initiation3
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 initiation4
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 initiationSecondary outcomes
1
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 initiation2
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
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 initiation4
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 initiationOther outcomes
1
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 initiation2
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 initiation3
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 initiation4
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 initiationSponsors and contacts
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Source ClinicalTrials.gov