This study is currently not recruiting participants.

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

Study on Sinus Condition with Nasal Polyps in Adults

Not Recruiting
18 years or above
All
Phase N/A
148 participants needed

Study Overview

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

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chronic Rhinosinusitis With Nasal Polyps
  • Age: 18 years or above
  • Gender: All

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.

This study investigates chronic rhinosinusitis with nasal polyps. The purpose of this study is to understand the clinical characteristics of the condition in terms of disease severity and related comorbidities.

The study focuses on evaluating the progression of treatment outcomes and healthcare resource utilization among participants. It evaluates factors such as the number of visits and the use of healthcare resources.

  • Who can participate: Adults aged 18 and older diagnosed with chronic rhinosinusitis with nasal polyps for at least one year can participate.
  • Study details: Participants will be observed to describe their clinical characteristics and treatment outcomes. A placebo may be used in this study.
Updated on 11 Jul 2024. Study ID: NCT05649813