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

Sponsor
Sanofi (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05649813
Collaborator
(none)
148
Enrollment
1
Location
17.3
Anticipated Duration (Months)
8.5
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    148 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective Registry on Chronic RhinoSinusitis With Nasal Polyps In the Greater Gulf Region
    Actual Study Start Date :
    Nov 20, 2022
    Anticipated Primary Completion Date :
    May 1, 2024
    Anticipated Study Completion Date :
    May 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    CRSwNP

    Participants with CRSwNP in the Gulf region

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of participants with mild, moderate or severe disease (measured by visual analogue scale [VAS] score) [Day 0 (baseline) to Month 12]

    2. The mean baseline Sinonasal Outcome Test (SNOT-22) scores [Day 0]

    3. The mean baseline nasal polyps score (NPS) [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 [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) [Day 0]

    6. 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 Outcome Measures

    1. The mean change in the baseline Sinonasal Outcome Test (SNOT-22) scores [Day 0 (baseline), Month 3, Month 6, and Month 12]

    2. The mean change in the baseline nasal polyps score (NPS) [Day 0, Month 3, Month 6, and Month 12]

    3. Mean change in the baseline total symptoms score (TSS) [Day 0, Month 6, and Month 12]

    4. The proportion of CRSwNP patients with hospitalization [Day 0 to Month 12]

    5. The proportion of CRSwNP patients with emergency room (ER), office, or general practitioner visits [Day 0 to Month 12]

    6. The mean number of days/visits to ER, office, or general practitioner [Day 0 to Month 12]

    7. The mean number of days of sick leaves [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]) [Day 0 to Month 12]

    9. The mean number of participants with CRSwNP who need surgical treatment [Day 0 to Month 12]

    10. Total number of surgeries [Day 0 to Month 12]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigational Site Number: 01 Kuwait Kuwait 11111

    Sponsors and Collaborators

    • Sanofi

    Investigators

    • Study Director: Clinical Sciences & Operations, Sanofi

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sanofi
    ClinicalTrials.gov Identifier:
    NCT05649813
    Other Study ID Numbers:
    • OBS17627
    • U1111-1279-3286
    First Posted:
    Dec 14, 2022
    Last Update Posted:
    Dec 14, 2022
    Last Verified:
    Dec 5, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Sinusitis
    Nasal Polyps
    Polyps

    Study Results

    No Results Posted as of Dec 14, 2022