A Study in Male and Female Adult Participants With Chronic Rhinosinusitis With Nasal Polyps In the Greater Gulf Region
Completed
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Registration Number
- NCT05649813
- Lead Sponsor
- Sanofi
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 148
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The mean baseline nasal polyps score (NPS) Day 0 Percentage of participants with Type 2 inflammation-related comorbidities including bronchial asthma, allergic rhinitis, atopic dermatitis, chronic spontaneous urticaria, eosinophilic esophagitis (EoE), and food allergy Day 0 Percentage of participants with other associated comorbidities including chronic obstructive pulmonary disease (COPD), ulcerative colitis, eosinophilic gastritis, or other comorbidities (if relevant) Day 0 Percentage of participants with mild, moderate or severe disease (measured by visual analogue scale [VAS] score) Day 0 (baseline) to Month 12 The mean baseline Sinonasal Outcome Test (SNOT-22) scores Day 0 Percentage of different medications used by participants with CRSwNP during the follow-up period as per decision of the treating physician Day 0 to Month 12
- Secondary Outcome Measures
Name Time Method The mean change in the baseline Sinonasal Outcome Test (SNOT-22) scores Day 0 (baseline), Month 3, Month 6, and Month 12 The mean change in the baseline nasal polyps score (NPS) Day 0, Month 3, Month 6, and Month 12 Mean change in the baseline total symptoms score (TSS) Day 0, Month 6, and Month 12 The proportion of surgical procedures performed during the hospital visit including nasal polypectomy with additional sinus dissection, isolated nasal polypectomy, or functional endoscopic sinus surgery [FESS]) Day 0 to Month 12 Total number of surgeries Day 0 to Month 12 The mean number of participants with CRSwNP who need surgical treatment Day 0 to Month 12 The proportion of CRSwNP patients with hospitalization Day 0 to Month 12 The mean number of days/visits to ER, office, or general practitioner Day 0 to Month 12 The mean number of days of sick leaves Day 0 to Month 12 The proportion of CRSwNP patients with emergency room (ER), office, or general practitioner visits Day 0 to Month 12
Trial Locations
- Locations (1)
Investigational Site Number: 01
🇰🇼Kuwait, Kuwait