Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1279-3286 | Registry Identifier | ICTRP |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRSwNP | Participants with CRSwNP in the Gulf region |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 different medications used by participants with CRSwNP during the follow-up period as per decision of the treating physician | Day 0 to Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Participants with CRSwNP
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number: 01 | Kuwait City | 11111 | Kuwait |
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Mean change in the baseline total symptoms score (TSS) | Day 0, Month 6, and Month 12 |
| The proportion of CRSwNP patients with hospitalization | Day 0 to Month 12 |
| The proportion of CRSwNP patients with emergency room (ER), office, or general practitioner visits | 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 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 |
| The mean number of participants with CRSwNP who need surgical treatment | Day 0 to Month 12 |
| Total number of surgeries | Day 0 to Month 12 |