Predicting sensitivity to glucocorticoid therapy for chronic rhinosinusitis with nasal polyps
Establishment of CST1 Predictive Model of Oral Glucocorticoid Therapy Sensitivity for Chronic Rhinosinusitis With Polyps
This study is testing if measuring certain levels in nasal secretions can help predict how well people with chronic rhinosinusitis and nasal polyps will respond to treatment with oral glucocorticoids.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Beijing Tongren Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05598424 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to develop a predictive model for oral glucocorticoid therapy sensitivity in patients with chronic rhinosinusitis with nasal polyps by measuring CST1 levels in nasal secretions. It is a single-arm, multicenter trial that evaluates patients before and after treatment with oral glucocorticoids. Key assessments include endoscopic polyp scores, Total Nasal Symptom Scores (TNSS), and SNOT-22 scores to determine treatment efficacy. The study seeks to identify biomarkers that correlate with treatment response, potentially improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 diagnosed with chronic rhinosinusitis with nasal polyps and exhibiting significant nasal polyp size.
Not a fit: Patients with contraindications to oral glucocorticoids or those with specific conditions like fungal sinusitis or cystic fibrosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients with chronic rhinosinusitis with nasal polyps.
How similar studies have performed: While the approach of using CST1 levels to predict glucocorticoid sensitivity is novel, similar studies have shown promise in identifying biomarkers for treatment response in other conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. All meet the diagnostic criteria of CRSwNP in EPOS2020 (Age 18-70 years old); 2. Investigator-assessed endoscopic bilateral Nasal Polyp Size Score (NPSS) was greater than or equal to 4 (minimum score of 2 per nasal cavity); Exclusion Criteria: 1. Oral glucocorticoid contraindications, such as diabetes, femoral head necrosis, gastric ulcer, etc. 2. Medication history of oral glucocorticoids or immunomodulator within 1 months before enrollment, antibiotics within 2 weeks; 3. fungal sinusitis, allergic fungal sinusitis (AFRS), cystic fibrosis, primary ciliary dyskinesia
Where this trial is running
Beijing, Beijing
- Beijing Tongren Hospital, Capital Medical University — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Lou Zhang
- Email: dr.luozhang@139.com
- Phone: +86-13910830399
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.