A Study in Male and Female Adult Participants With Chronic Rhinosinusitis With Nasal Polyps In the Greater Gulf Region
NCT ID: NCT05649813
Last Updated: 2024-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
148 participants
OBSERVATIONAL
2022-11-20
2024-06-14
Brief Summary
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\- 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).
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CRSwNP
Participants with CRSwNP in the Gulf region
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number: 01
Kuwait City, , Kuwait
Countries
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Other Identifiers
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U1111-1279-3286
Identifier Type: REGISTRY
Identifier Source: secondary_id
OBS17627
Identifier Type: -
Identifier Source: org_study_id
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