Predictive Factors in Chronic Rhinosinusitis With Nasal Polyps

Chronic Rhinosinusitis With Nasal Polyps Clinical Trial

Official title:

Predictive Factors in Chronic Rhinosinusitis With Nasal Polyps

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06459622
• Other study ID #: Chronic rhinosinusitis
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: May 2025

Study information

• Verified date: March 2024
• Source: Assiut University
• Contact: Katrina Atef, General practitioner
• Phone: 01220058161
• Email: Katyatef90[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 102
• Est. completion date: May 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Rhinosinusitis With Nasal Polyps
• Nasal Polyps
• Polyps
• Rhinosinusitis
• Sinusitis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Katrina Atef Habashy	Assiut University

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Eosinophils in nasal polyp tissue	Eosinophils is related to the inflammatory process of CRSwNP	Baseline
Primary	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