Predictive Factors in Chronic Rhinosinusitis With Nasal Polyps
1 other identifier
interventional
102
0 countries
N/A
Brief Summary
The study will be conducted to identify factors predicting the response of chronic rhinosinusitis with nasal polyps ( CRSwNP) to oral corticosteroids.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2024
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2024
CompletedFirst Posted
Study publicly available on registry
June 14, 2024
CompletedStudy Start
First participant enrolled
July 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2025
CompletedJune 14, 2024
March 1, 2024
8 months
March 31, 2024
June 10, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Serum IL-25 is measured to releave the relation between them and the response of CRSwNP to oral corticosteroids
Serum IL-25 is related to the effect of corticosteroids on CRSwNP
Baseline
Other Outcomes (1)
Eosinophils in nasal polyp tissue
Baseline
Study Arms (2)
Sensitive to corticosteroids
EXPERIMENTALPatients who are sensitive to corticosteroids have high serum IL-25
Non sensitive to corticosteroids
EXPERIMENTALPatients who aren't sensitive to corticosteroids have low serum IL-25
Interventions
Serum IL-25 and eosinophils in nasal polyps tisuer obtained and measured to identify the sensitivity of nasal polyps to corticosteroids
Eligibility Criteria
You may qualify if:
- clinical diagnosis of chronic rhinosinusitis with nasal polyps
You may not qualify if:
- Patients who had taken any steroid , antihistamine or other immune-modulating medications within the past 4 weeks
- previous nasal and sinus surgery.
- Allergic Fungal rhinosinusitis.
- Unilateral rhinosinusitis.
- Antrochoanal polyps or cystic fibrosis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Katrina Atef Habashylead
- Assiut Universitycollaborator
Related Publications (1)
Shin HW, Kim DK, Park MH, Eun KM, Lee M, So D, Kong IG, Mo JH, Yang MS, Jin HR, Park JW, Kim DW. IL-25 as a novel therapeutic target in nasal polyps of patients with chronic rhinosinusitis. J Allergy Clin Immunol. 2015 Jun;135(6):1476-85.e7. doi: 10.1016/j.jaci.2015.01.003. Epub 2015 Feb 25.
PMID: 25725991BACKGROUND
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Predictive factors in response of chronic rhinosinusitis with nasal polyps to corticosteroids
Study Record Dates
First Submitted
March 31, 2024
First Posted
June 14, 2024
Study Start
July 1, 2024
Primary Completion
March 1, 2025
Study Completion
May 1, 2025
Last Updated
June 14, 2024
Record last verified: 2024-03