A Study in Male and Female Adult Participants With Chronic Rhinosinusitis With Nasal Polyps In the Greater Gulf Region
Investigation of Chronic Sinus Inflammation with Nasal Polyps in Adults
Study Overview
Primary Objective:
- To describe the clinical characteristics of participants with chronic rhinosinusitis with nasal polyps (CRSwNP) in terms of disease severity, Type 2 inflammation-related comorbidities (such as asthma and allergic rhinitis), other associated comorbidities, and treatments used in a real-world setting
Secondary Objectives:
- Describe the progression in treatment outcomes at different visits (baseline, 3 months, 6 months, and 12 months).
- To assess the healthcare resource utilization of participants with CRSwNP in countries of the Gulf region (number of visits, emergency room (ER), surgery, etc).
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Chronic Rhinosinusitis With Nasal Polyps
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Age: 18 years or above
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Gender: All
Inclusion Criteria:
- Male or female participants.
- Participants diagnosed with chronic rhinosinusitis with nasal polyps (CRSwNP) for at least one year prior to study start.
- Participants diagnosed with CRSwNP according to criteria of American Academy of Otolaryngology-Head and Neck Surgery (i.e. the diagnosis is confirmed in medical records by clinical symptoms and objective evidence of nasal polyps by using anterior rhinoscopy and nasal endoscopy when available and/or computed tomography (CT) scan).
- Participants should be at least 18 years old.
- Participants must have signed an informed consent.
Exclusion Criteria:
- Participants with chronic rhinosinusitis without nasal polyps (CRSsNP)
- Pregnant/breastfeeding participants or participants planning for a pregnancy.
- Participants participating in other interventional clinical trials involving any investigational drug.
- Participants with granulomatous diseases such as vasculitis or sarcoidosis. The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
This study investigates chronic rhinosinusitis with nasal polyps (CRSwNP), focusing on understanding the clinical characteristics, disease severity, and associated conditions like asthma and allergic rhinitis without defining the condition itself.
Participants will undergo various procedures, including assessments at different visits to track treatment outcomes. The study will also evaluate healthcare resource usage, such as the number of visits to healthcare facilities, emergency room visits, and surgeries. The aim is to gather data in a real-world setting to better understand how CRSwNP is managed in the Gulf region.
- Who can participate: Adults 18 and older diagnosed with chronic sinus inflammation with nasal polyps for at least one year can participate. Diagnosis must be confirmed by clinical symptoms and medical records, and informed consent is required.
- Study details: Treatment outcomes will be assessed at baseline, 3, 6, and 12 months. Healthcare resource usage, including facility visits and surgeries, will be monitored to understand CRSwNP management.
