Actively Recruiting
Open-label Single-arm, Non-interventional, Multi-centre Study for Evaluation of Clinical and Patient Reported Outcomes in Adult Patients With CRSwNP on Tezepelumab
Led by AstraZeneca · Updated on 2026-06-03
110
Participants Needed
11
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to collect real-world data on the use and effects of tezepelumab in adults with Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), including those who also have asthma. The study is observational, non-interventional, and conducted at multiple centers in the Russian Federation. It involves participants who started tezepelumab treatment no more than four weeks before joining the study, reflecting everyday medical practice outside of controlled trials. Participants will be observed without any changes to their prescribed treatment. Data will be collected retrospectively and prospectively from medical records and follow-up over approximately one year. The study will track changes in nasal polyp status, nasal congestion, and other symptoms using standardized scores at the beginning and at weeks 4, 24, and 52 after starting tezepelumab. During the study, participants will continue their usual care with their doctors while researchers collect information on symptoms, quality of life, healthcare visits, hospitalizations, and treatment duration. They will also monitor changes in blood markers and asthma-related events. Overall, the study seeks to understand how tezepelumab is used and its effects in a real-world setting over a one-year period.
CONDITIONS
Brief Title
ReAl-woRld Evaluation of tEzepelumab for Chronic rhinoSinusitis With Nasal Polyps in Russia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older at the time of signing the informed consent.
- Diagnosis of Chronic Rhinosinusitis With Nasal Polyps established for at least 52 weeks before starting tezepelumab.
- Medical records available for at least 52 weeks before tezepelumab initiation, including history of systemic corticosteroid use or nasal polyps surgery.
- Treatment with tezepelumab prescribed and started within 4 weeks before enrollment.
- Severity of nasal polyps requiring surgery, defined by a total Nasal Polyp Score of 5 or higher at enrollment.
- Nasal Blockage score of 3 or higher on the Sinonasal Outcome Test-22 at enrollment.
- Total Sinonasal Outcome Test-22 score of 30 or higher at enrollment or within 12 weeks before enrollment.
- Currently receiving care from specialist physicians such as otolaryngologists at the study site.
- Provision of signed and dated informed consent.
- Ability to read, understand, and complete required questionnaires.
You will not qualify if you...
- Any contraindication to tezepelumab as per approved product information or investigator's judgment.
- Use of another biologic drug for Chronic Rhinosinusitis With Nasal Polyps or asthma at the time of enrollment, except stable allergen immunotherapy.
- Participation in another observational study that could affect assessments or in an interventional clinical trial in the last 3 months.
- Pregnancy or breastfeeding.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 52 weeks following tezepelumab initiation
Participants who have started tezepelumab treatment are observed to collect real-world data on their clinical and patient-reported outcomes over one year.
Baseline and visits at Weeks 4, 24, and 52
Trial Site Locations
Total: 11 locations
1
Research Site
Kazan', Russia
Actively Recruiting
2
Research Site
Kemerovo, Russia
Not Yet Recruiting
3
Research Site
Krasnoyarsk, Russia
Actively Recruiting
4
Research Site
Moscow, Russia
Actively Recruiting
5
Research Site
Moscow, Russia
Not Yet Recruiting
6
Research Site
Rostov-on-Don, Russia
Actively Recruiting
7
Research Site
Ryazan, Russia
Actively Recruiting
8
Research Site
Saint-Petesburg, Russia
Actively Recruiting
9
Research Site
Saint-Petesburg, Russia
Not Yet Recruiting
10
Research Site
Ulyanovsk, Russia
Actively Recruiting
11
Research Site
Yekaterinburg, Russia
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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