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

Chronic Rhinosinusitis With Nasal Polyps Clinical Trial

Official title:

Prospective Registry on Chronic RhinoSinusitis With Nasal Polyps In the Greater Gulf Region

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05649813
• Other study ID #: OBS17627
• Secondary ID: U1111-1279-3286
• Status: Active, not recruiting
• Start date: November 20, 2022
• Est. completion date: June 7, 2024

Study information

• Verified date: April 2024
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 148
• Est. completion date: June 7, 2024
• Est. primary completion date: June 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Rhinosinusitis With Nasal Polyps
• Nasal Polyps
• Polyps
• Rhinosinusitis
• Sinusitis

Locations

Country	Name	City	State
Kuwait	Investigational Site Number: 01	Kuwait

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Kuwait, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with mild, moderate or severe disease (measured by visual analogue scale [VAS] score)		Day 0 (baseline) to Month 12
Primary	The mean baseline Sinonasal Outcome Test (SNOT-22) scores		Day 0
Primary	The mean baseline nasal polyps score (NPS)		Day 0
Primary	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
Primary	Percentage of participants with other associated comorbidities including chronic obstructive pulmonary disease (COPD), ulcerative colitis, eosinophilic gastritis, or other comorbidities (if relevant)		Day 0
Primary	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	The mean change in the baseline Sinonasal Outcome Test (SNOT-22) scores		Day 0 (baseline), Month 3, Month 6, and Month 12
Secondary	The mean change in the baseline nasal polyps score (NPS)		Day 0, Month 3, Month 6, and Month 12
Secondary	Mean change in the baseline total symptoms score (TSS)		Day 0, Month 6, and Month 12
Secondary	The proportion of CRSwNP patients with hospitalization		Day 0 to Month 12
Secondary	The proportion of CRSwNP patients with emergency room (ER), office, or general practitioner visits		Day 0 to Month 12
Secondary	The mean number of days/visits to ER, office, or general practitioner		Day 0 to Month 12
Secondary	The mean number of days of sick leaves		Day 0 to Month 12
Secondary	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
Secondary	The mean number of participants with CRSwNP who need surgical treatment		Day 0 to Month 12
Secondary	Total number of surgeries		Day 0 to Month 12