NCT05598411

CST1-Guided Oral Glucocorticoids Management for CRSwNP

Efficacy of CST1-Guided Oral Glucocorticoid Therapy for Chronic Rhinosinusitis With Polyps

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Beijing Tongren Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Topical and systemic steroids constitute the first choice in medical treatment for nasal polyps. Glucocorticoids sensitivity is significantly correlated with CST1 in nasal secretions. The goal of this randomized, double-blind, placebo-controlled clinical trial is to clarify the efficacy of a short course of CST1-guided oral glucocorticoids therapy for chronic rhinosinusitis with nasal polyps. Subjects were randomized to receive either oral glucocorticoids or oral placebo for 2 weeks. Endoscopic polyp score, Total Nasal Symptom Score(TNSS), SNOT-22 score, Cystatin 1 and other biomarkers were evaluated before and after the treatment. Researchers will compare oral glucocorticoids group and oral placebo group to test CST1 predictive model of glucocorticoid therapy for Chronic Rhinosinusitis with Polyps.

Conditions

• Chronic Rhinosinusitis With Nasal Polyps
• Glucocorticoids

Interventions

Type	Name	Description
DRUG	Oral Glucocorticoids	methylprednisolone 24mg qd, 2-week duration
DRUG	Oral placebo	oral placebo 24mg qd, 2-week duration

Timeline

• Start date: 2022-10-17
• Primary completion: 2024-12-30
• Completion: 2025-11-01
• First posted: 2022-10-28
• Last updated: 2022-10-28

Locations

1 site across 1 country: China