CST1-Guided Oral Glucocorticoids Management for CRSwNP
NCT05598411 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2022-10-28
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
- DRUG
-
Oral Glucocorticoids
methylprednisolone 24mg qd, 2-week duration
- DRUG
-
Oral placebo
oral placebo 24mg qd, 2-week duration
Sponsors & Collaborators
-
Beijing Tongren Hospital
lead OTHER
Principal Investigators
-
Luo Zhang · Beijing Tongren Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-17
- Primary Completion
- 2024-12-30
- Completion
- 2025-11-01
Countries
- China
Study Locations
More Related Trials
-
A Study of CM326 in Patients With Chronic Rhinosinusitis With Nasal Polyps
NCT05324137 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study to Evaluate 611 in Patients With Chronic Rhinosinusitis With Nasal Polyps
NCT05865496 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Systemic Corticosteroids in the Perioperative Management of Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
NCT02119273 ·Status: WITHDRAWN ·Phase: PHASE4
-
Subcutaneously CM310/Placebo in Patients With Chronic Rhinosinusitis With Nasal Polyposis (CROWNS-1)
NCT04805398 ·Status: COMPLETED ·Phase: PHASE2
-
Prednisone in Chronic Rhinosinusitis Without Nasal Polyps
NCT02367118 ·Status: UNKNOWN ·Phase: PHASE3
-
Efficacy and Safety of Budesonide Inhalation Suspension for the Treatment of Chronic Rhinosinusitis With Polyposis.
NCT03687515 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of SHR-1905 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps
NCT05891483 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Corticosteroid Therapy for Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
NCT01676415 ·Status: TERMINATED ·Phase: PHASE4
-
Chronic Rhinosinusitis With or Without Nasal Polyps Steroid Study
NCT00841802 ·Status: WITHDRAWN ·Phase: PHASE4
-
Olfaction and Inflammation in Chronic Rhinosinusitis With Nasal Polyps
NCT04104594 ·Status: TERMINATED ·Phase: NA
-
GB001 in Adult Participants With Chronic Rhinosinusitis
NCT03956862 ·Status: COMPLETED ·Phase: PHASE2
-
Study of the Efficacy of Topical Nasal Steroids Patients With Nasal Polyps
NCT01777906 ·Status: COMPLETED
-
A Extension Clinical Study of TQC2731 Injection in the Treatment of Chronic Sinusitis With Nasal Polyps
NCT06451640 ·Status: COMPLETED ·Phase: PHASE2
-
Perioperative Oral Steroids for Chronic Rhinosinusitis Without Polyps (CRSsNP)
NCT02748070 ·Status: COMPLETED ·Phase: NA
-
Compare the Effects of Fluticasone Furoate Nasal Spray vs Placebo in Patients With Nasal Polypoid Disease
NCT01013701 ·Status: TERMINATED ·Phase: PHASE4
-
Correlation Between the Microbiome and Type 2 Inflammatory Diseases of CRSwNP
NCT06231004 ·Status: NOT_YET_RECRUITING
-
Tapering of Biologics in Chronic Rhinosinusitis With Nasal Polyps
NCT07187583 ·Status: RECRUITING ·Phase: PHASE4
-
Effects and Safety of Budesonide Inhalation Suspension Via Transnasal Nebulization in Nasal Polyps
NCT02024659 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
A Prospective Single-center Cohort Study of Surgical Treatment of Chronic Rhinosinusitis
NCT06010316 ·Status: RECRUITING
-
A Clinical Study of TQC2731 Injection in the Treatment of Chronic Rhinosinusitis With Nasal Polyps
NCT06036927 ·Status: COMPLETED ·Phase: PHASE2
-
Anti-IL-5 Therapy With Simple Polypectomy Versus Extended Endoscopic Sinus Surgery for CRSwNP
NCT07200336 ·Status: NOT_YET_RECRUITING ·Phase: PHASE4
-
Efficacy and Safety of SHR-1905 Injection in Subjects With Chronic Rhinosinusitis With Nasal Polyps
NCT07132827 ·Status: RECRUITING ·Phase: PHASE3
-
The Effects of Steroid-eluting Stent Implant for the Treatment of Eosinophilic Chronic Rhinosinusitis With Nasal Polyps
NCT03943121 ·Status: UNKNOWN ·Phase: NA
-
Etokimab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
NCT03614923 ·Status: COMPLETED ·Phase: PHASE2
-
An Open-label Study to Identify Molecular Markers of Steroid Resistance
NCT01616160 ·Status: TERMINATED ·Phase: PHASE4