Predictive Factors in Chronic Rhinosinusitis With Nasal Polyps

The study will be conducted to identify factors predicting the response of chronic rhinosinusitis with nasal polyps ( CRSwNP) to oral corticosteroids.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Rhinosinusitis With Nasal Polyps
• Intervention / Treatment: Diagnostic test: Serum IL_25 and eosinophils in nasal polyp tisuee

Detailed Description

Treatment of nasal polyposis is divided into medical or surgical treatment .

Steroids are widely used as the most effective medicine in nasal polyposis. Although oral corticosteroids are one of the frequently used treatments in the management of chronic rhinosinusitis with nasal polyps (CRSwNP), there is lack of effective means of predicting corticosteroid sensitivity in those patients. It was reported that the overall sensitivity rates of corticosteroid therapy to nasal polyps( NP) were only between 53.8% and 80%.. Many reports stated that serum and tissue interleukeine 25 (IL 25) and serum and tissue eosinophalia are good predictors to the response of CRSwNP to oral corticosteroids.

Interleukeine 25(IL-25), an important epithelial-derived proinflammatory cytokine, plays various roles in different inflammatory and allergic diseases, such as asthma and atopic dermatitis .

Hong et al demonstrated that the levels of IL-25 in NP tissues and in serum, as well as the NP endoscopic scores, were significantly elevated in the corticosteroid-sensitive patients compared with the non-sensitive ones. In general, eosinophilic NPs are pharmacologically glucocorticoid responsive, but non-eosinophilic or neutrophilic CRSwNP is frequently resistant to steroid treatment.

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katrina Atef, General practitioner; Phone Number: 01220058161; Email: Katyatef90@gmail.com
• Study Contact Backup: Name: Alla Kamel, Professor; Phone Number: 01005534200; Email: alaakamel@med.aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• clinical diagnosis of chronic rhinosinusitis with nasal polyps

Exclusion Criteria:

• 1-Patients who had taken any steroid , antihistamine or other immune-modulating medications within the past 4 weeks

  2- previous nasal and sinus surgery.

  3-Allergic Fungal rhinosinusitis.

  4-Unilateral rhinosinusitis.

  5- Antrochoanal polyps or cystic fibrosis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sensitive to corticosteroids; Patients who are sensitive to corticosteroids have high serum IL-25	Diagnostic test: Serum IL_25 and eosinophils in nasal polyp tisuee; Serum IL-25 and eosinophils in nasal polyps tisuer obtained and measured to identify the sensitivity of nasal polyps to corticosteroids
Experimental: Non sensitive to corticosteroids; Patients who aren't sensitive to corticosteroids have low serum IL-25	Diagnostic test: Serum IL_25 and eosinophils in nasal polyp tisuee; Serum IL-25 and eosinophils in nasal polyps tisuer obtained and measured to identify the sensitivity of nasal polyps to corticosteroids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eosinophils in nasal polyp tissue	Eosinophils is related to the inflammatory process of CRSwNP	Baseline

Collaborators and Investigators

• Sponsor: Katrina Atef Habashy
• Collaborators: Assiut University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: March 31, 2024
• First Submitted That Met QC Criteria: June 10, 2024
• First Posted (Actual): June 14, 2024

Study Record Updates

• Last Update Posted (Actual): June 14, 2024
• Last Update Submitted That Met QC Criteria: June 10, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Paranasal Sinus Diseases; Nose Diseases; Rhinitis; Sinusitis; Nasal Polyps; Polyps; Rhinosinusitis
• Other Study ID Numbers: Chronic rhinosinusitis

Plan for Individual participant data (IPD)

Study Data/Documents

1. Clinical Study Report

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No