Clinical trial NCT05649813: A Study in Male and Female Adult Participants With Chronic Rhinosinusitis With Nasal Polyps In the Greater Gulf Region
Official title: Prospective Registry on Chronic RhinoSinusitis With Nasal Polyps In the Greater Gulf Region
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Rhinosinusitis With Nasal Polyps
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2022-12-14
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with CRSwNP

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of participants with mild, moderate or severe disease (measured by visual analogue scale [VAS] score)
timeFrame: Day 0 (baseline) to Month 12
measure: The mean baseline Sinonasal Outcome Test (SNOT-22) scores
timeFrame: Day 0
measure: The mean baseline nasal polyps score (NPS)
timeFrame: Day 0
measure: 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
timeFrame: Day 0
measure: Percentage of participants with other associated comorbidities including chronic obstructive pulmonary disease (COPD), ulcerative colitis, eosinophilic gastritis, or other comorbidities (if relevant)
timeFrame: Day 0
measure: Percentage of different medications used by participants with CRSwNP during the follow-up period as per decision of the treating physician
timeFrame: Day 0 to Month 12
Secondary outcomes:
measure: The mean change in the baseline Sinonasal Outcome Test (SNOT-22) scores
timeFrame: Day 0 (baseline), Month 3, Month 6, and Month 12
measure: The mean change in the baseline nasal polyps score (NPS)
timeFrame: Day 0, Month 3, Month 6, and Month 12
measure: Mean change in the baseline total symptoms score (TSS)
timeFrame: Day 0, Month 6, and Month 12
measure: The proportion of CRSwNP patients with hospitalization
timeFrame: Day 0 to Month 12
measure: The proportion of CRSwNP patients with emergency room (ER), office, or general practitioner visits
timeFrame: Day 0 to Month 12
measure: The mean number of days/visits to ER, office, or general practitioner
timeFrame: Day 0 to Month 12
measure: The mean number of days of sick leaves
timeFrame: Day 0 to Month 12
measure: 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])
timeFrame: Day 0 to Month 12
measure: The mean number of participants with CRSwNP who need surgical treatment
timeFrame: Day 0 to Month 12
measure: Total number of surgeries
timeFrame: Day 0 to Month 12
Other outcomes:
Locations:
city: Kuwait
country: Kuwait
facility: Investigational Site Number: 01
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: