Establishment of CST1 Predictive Model of Oral Glucocorticoid Therapy Sensitivity for Chronic Rhinosinusitis With Polyps

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Topical and systemic steroids constitute the first choice in medical treatment for nasal polyps. Glucocorticoids sensitivity is significantly correlated with CST1 level in nasal secretions. The goal of this single-arm clinical trial based on a multicenter platform is to test CST1 in patients with chronic rhinosinusitis and nasal polyps before and after oral glucocorticoid therapy. Endoscopic polyp score, Total Nasal Symptom Score(TNSS), SNOT-22 score and other biomarkers are also evaluated before and after the treatment. Researchers will develop a CST1 predictive model of oral glucocorticoid therapy for Chronic Rhinosinusitis with Polyps.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• All meet the diagnostic criteria of CRSwNP in EPOS2020 (Age 18-70 years old);

• Investigator-assessed endoscopic bilateral Nasal Polyp Size Score (NPSS) was greater than or equal to 4 (minimum score of 2 per nasal cavity);

Locations
Other Locations
China
Beijing Tongren Hospital, Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Lou Zhang
dr.luozhang@139.com
+86-13910830399
Time Frame
Start Date: 2022-11-22
Estimated Completion Date: 2025-11-01
Participants
Target number of participants: 150
Treatments
Experimental: Oral Glucocorticoids group
Intervention Period I: nasal spray, Budesonide Nasal Spray, 64ug per Nostril, bid, for 4-week duration.~Intervention Period II: oral glucocorticoids methylprednisolone 24mg qd, and nasal spray, Budesonide Nasal Spray 64ug per Nostril, bid, for 2-week duration.
Sponsors
Leads: Beijing Tongren Hospital

This content was sourced from clinicaltrials.gov