A Study in Male and Female Adult Participants With Chronic Rhinosinusitis With Nasal Polyps In the Greater Gulf Region

Sanofi

Status: Completed

Conditions: Chronic Rhinosinusitis With Nasal Polyps

Study type: Observational

Funder types: Industry

Identifiers

NCT05649813

U1111-1279-3286 (Registry Identifier)

OBS17627

Details and patient eligibility

About

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).

Enrollment: 148 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

148 participants in 1 patient group

CRSwNP

Description:

Participants with CRSwNP in the Gulf region