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Completed

NCT Number: NCT05649813

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

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).

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Key information

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigational Site Number: 01

Kuwait City, 11111, Kuwait

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Percentage of participants with mild, moderate or severe disease (measured by visual analogue scale [VAS] score)

    Time frame: Day 0 (baseline) to Month 12

  2. The mean baseline Sinonasal Outcome Test (SNOT-22) scores

    Time frame: Day 0

  3. The mean baseline nasal polyps score (NPS)

    Time frame: Day 0

  4. 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

    Time frame: Day 0

  5. Percentage of participants with other associated comorbidities including chronic obstructive pulmonary disease (COPD), ulcerative colitis, eosinophilic gastritis, or other comorbidities (if relevant)

    Time frame: Day 0

  6. Percentage of different medications used by participants with CRSwNP during the follow-up period as per decision of the treating physician

    Time frame: Day 0 to Month 12

Secondary outcomes

  1. The mean change in the baseline Sinonasal Outcome Test (SNOT-22) scores

    Time frame: Day 0 (baseline), Month 3, Month 6, and Month 12

  2. The mean change in the baseline nasal polyps score (NPS)

    Time frame: Day 0, Month 3, Month 6, and Month 12

  3. Mean change in the baseline total symptoms score (TSS)

    Time frame: Day 0, Month 6, and Month 12

  4. The proportion of CRSwNP patients with hospitalization

    Time frame: Day 0 to Month 12

  5. The proportion of CRSwNP patients with emergency room (ER), office, or general practitioner visits

    Time frame: Day 0 to Month 12

  6. The mean number of days/visits to ER, office, or general practitioner

    Time frame: Day 0 to Month 12

  7. The mean number of days of sick leaves

    Time frame: Day 0 to Month 12

  8. 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])

    Time frame: Day 0 to Month 12

  9. The mean number of participants with CRSwNP who need surgical treatment

    Time frame: Day 0 to Month 12

  10. Total number of surgeries

    Time frame: Day 0 to Month 12

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 14, 2022
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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