Predictive Factors in Chronic Rhinosinusitis With Nasal Polyps

NCT ID: NCT06459622

Last Updated: 2024-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-31

Study Completion Date

2025-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Rhinosinusitis With Nasal Polyps

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sensitive to corticosteroids

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

Group Type EXPERIMENTAL

Serum IL_25 and eosinophils in nasal polyp tisuee

Intervention Type DIAGNOSTIC_TEST

Serum IL-25 and eosinophils in nasal polyps tisuer obtained and measured to identify the sensitivity of nasal polyps to corticosteroids

Non sensitive to corticosteroids

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

Group Type EXPERIMENTAL

Serum IL_25 and eosinophils in nasal polyp tisuee

Intervention Type DIAGNOSTIC_TEST

Serum IL-25 and eosinophils in nasal polyps tisuer obtained and measured to identify the sensitivity of nasal polyps to corticosteroids

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role collaborator

Katrina Atef Habashy

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Katrina Atef Habashy

Predictive factors in response of chronic rhinosinusitis with nasal polyps to corticosteroids

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Katrina Atef, General practitioner

Role: CONTACT

01220058161

Alla Kamel, Professor

Role: CONTACT

01005534200

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 25725991 (View on PubMed)

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.

Document Type: Clinical Study Report

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Chronic rhinosinusitis

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

CST1-Guided Oral Glucocorticoids Management for CRSwNP
NCT05598411 NOT_YET_RECRUITING PHASE4