Predictive Factors in Chronic Rhinosinusitis With Nasal Polyps

Katrina Atef Habashy

Status: Not yet enrolling

Conditions: Chronic Rhinosinusitis With Nasal Polyps

Treatments: Diagnostic Test: Serum IL_25 and eosinophils in nasal polyp tisuee

Study type: Interventional

Funder types: Other

Identifiers

NCT06459622

Chronic rhinosinusitis

Details and patient eligibility

About

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

Full 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.

Enrollment: 102 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

Sensitive to corticosteroids

Experimental group

Description:

Patients who are sensitive to corticosteroids have high serum IL-25

Treatment:

Diagnostic Test: Serum IL_25 and eosinophils in nasal polyp tisuee

Non sensitive to corticosteroids

Experimental group

Description:

Patients who aren't sensitive to corticosteroids have low serum IL-25

Treatment:

Diagnostic Test: Serum IL_25 and eosinophils in nasal polyp tisuee