Chronic Rhinosinusitis With Nasal PolypsNCT06459622
Predictive Factors in Chronic Rhinosinusitis With Nasal Polyps
A study testing Serum IL_25 and eosinophils in nasal polyp tisuee in people with Chronic Rhinosinusitis With Nasal Polyps, run by Katrina Atef Habashy.
Trial summary
The study will be conducted to identify factors predicting the response of chronic rhinosinusitis with nasal polyps ( CRSwNP) to oral corticosteroids. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps
- What is being tested?
- Serum IL_25 and eosinophils in nasal polyp tisuee
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- clinical diagnosis of chronic rhinosinusitis with nasal polyps
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
The study will be conducted to identify factors predicting the response of chronic rhinosinusitis with nasal polyps ( CRSwNP) to oral corticosteroids.
Read the 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.
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Being tested
- Serum IL_25 and eosinophils in nasal polyp tisuee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum IL_25 and eosinophils in nasal polyp tisueeDiagnostic test
Serum IL-25 and eosinophils in nasal polyps tisuer obtained and measured to identify the sensitivity of nasal polyps to corticosteroids
| Study group | Role | What they receive |
|---|---|---|
| Sensitive to corticosteroids | Experimental | Patients who are sensitive to corticosteroids have high serum IL-25 Receives: Diagnostic Test: Serum IL_25 and eosinophils in nasal polyp tisuee |
| Non sensitive to corticosteroids | Experimental | Patients who aren't sensitive to corticosteroids have low serum IL-25 Receives: Diagnostic Test: Serum IL_25 and eosinophils in nasal polyp tisuee |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study startJul 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Rhinosinusitis With Nasal PolypsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Katrina Atef Habashy
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University
- Responsible party
- Sponsor-investigator, Katrina Atef Habashy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459622
- Sponsor's protocol ID
- Chronic rhinosinusitis
- Status last verified
- Mar 2024
- First submitted
- 31 Mar 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 25725991
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors in Chronic Rhinosinusitis With Nasal Polyps
- ClinicalTrials.gov ID
- NCT06459622
- Acronym / sponsor ID
- Chronic rhinosinusitis
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Katrina Atef HabashyUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- Jul 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will be conducted to identify factors predicting the response of chronic rhinosinusitis with nasal polyps ( CRSwNP) to oral corticosteroids.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensitive to corticosteroids | Experimental | Diagnostic Test: Serum IL_25 and eosinophils in nasal polyp tisueePatients who are sensitive to corticosteroids have high serum IL-25 |
| Non sensitive to corticosteroids | Experimental | Diagnostic Test: Serum IL_25 and eosinophils in nasal polyp tisueePatients who aren't sensitive to corticosteroids have low serum IL-25 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- clinical diagnosis of chronic rhinosinusitis with nasal polyps
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum IL_25 and eosinophils in nasal polyp tisueeSerum IL-25 and eosinophils in nasal polyps tisuer obtained and measured to identify the sensitivity of nasal polyps to corticosteroids | Diagnostic test | Non sensitive to corticosteroids, Sensitive to corticosteroids |
Primary outcome
Serum IL-25 is measured to releave the relation between them and the response of CRSwNP to oral corticosteroids
Time frame: Baseline
Serum IL-25 is related to the effect of corticosteroids on CRSwNP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Background: PubMed 25725991Shin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Serum IL_25 and eosinophils in nasal polyp tisuee in people with Chronic Rhinosinusitis With Nasal Polyps, run by Katrina Atef Habashy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katrina Atef, General practitioner (01220058161, Katyatef90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum IL-25 is measured to releave the relation between them and the response of CRSwNP to oral corticosteroids (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06459622, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.