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

NCT05649813 | Completed

• 2 other identifiers: OBS17627U1111-1279-3286
• Study Type: observational
• Target: 148
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Outcome Measures

Primary Outcomes (6)

• 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

Secondary Outcomes (10)

• 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 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

Study Arms (1)

CRSwNP

Participants with CRSwNP in the Gulf region

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with CRSwNP

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational Site Number: 01

Kuwait City, 11111, Kuwait

Location

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: December 14, 2022
• Study Start: November 20, 2022
• Primary Completion: June 14, 2024
• Study Completion: June 14, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

KU (1)