Nasal Polyps Clinical Trials

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Open-label Single-arm, Non-interventional, Multi-centre Study for Evaluation of Clinical and Patient Reported Outcomes in Adult Patients With CRSwNP on Tezepelumab

Status: Recruiting
Location: See all (6) locations...
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• The severity of CRSwNP consistent with need for surgery as defined by total NPS ≥ 5 (at least 2 for each nostril) at the enrollment.

• Nasal Blockage score as part of SNOT-22 (NBS-SNOT-22) ≥ 3 at the enrollment.

• SNOT-22 total score ≥ 30 at enrollment or up to 12 weeks before enrollment.

• Currently receive care from specialist physicians (e.g., otolaryngologist) at the Investigator's or sub-Investigator's site.

• Provision of signed and dated written informed consent.

⁃ Participants are able to read, understand and complete the questionnaires required by the protocol.

Locations
Other Locations
Russian Federation
Research Site
RECRUITING
Kazan'
Research Site
NOT_YET_RECRUITING
Krasnoyarsk
Research Site
RECRUITING
Moscow
Research Site
RECRUITING
Ryazan
Research Site
RECRUITING
Saint-petesburg
Research Site
RECRUITING
Yekaterinburg
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2025-12-25
Estimated Completion Date: 2028-03-31
Participants
Target number of participants: 110
Sponsors
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov