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

Chronic Rhinosinusitis With Nasal Polyps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05598424
• Other study ID #: TR-CST1
• Status: Recruiting
• Phase: Phase 4
• Start date: November 22, 2022
• Est. completion date: November 1, 2025

Study information

• Verified date: March 2023
• Source: Beijing Tongren Hospital
• Contact: Lou Zhang
• Phone: +86-13910830399
• Email: dr.luozhang[@]139.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 1, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Rhinosinusitis With Nasal Polyps
• Glucocorticoids
• Nasal Polyps
• Polyps
• Sinusitis

Intervention

Drug:
• Oral Glucocorticoids
Oral Glucocorticoids(methylprednisolone) 24mg qd, 2-week duration

Locations

Country	Name	City	State
China	Beijing Tongren Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in endoscopic polyp score	Bilateral polyp volume size described using the Nasal Polyp Size Score (NPSS) score. (0 - 4 points per side: 0 = no polyp; 1 = small polyp in the middle meatus, not reaching the inferior border of the middle turbinate; 2 = small polyp in the middle meatus, reaching the inferior border of the middle turbinate; 3 = large polyp protruding from the middle meatus, not reaching the inferior border of the inferior turbinate; 4 = large polyp that almost causes most or complete obstruction of the nasal cavity.)	Baseline, week 4, week 6
Secondary	The change in Total Nasal Symptom Score	Total Nasal Symptom Score was are graded on a 3-point scale. (0= no symptoms; 1= mild symptoms; 2= moderate symptoms; 3= severe symptoms).	Baseline, week 4, week 6
Secondary	The change in SNOT-22 score	The 22-item Sino-nasal outcome test (SNOT-22) was used to evaluate the changes in symptoms of patients.; According to the severity of symptoms caused by RCRS, each item was divided into 6 levels: no distress (0 points), mild distress (1 point), mild distress (2 points) ), moderate distress (3 points), severe distress (4 points), very severe distress (5 points). The higher the score, the more severe the symptoms, and the final total score of the item is counted.	Baseline, week 4, week 6
Secondary	The change in asthma ACQ Score	For patients with asthma, we assessed the change of asthma symptoms through the Asthma Control Questionnaire(ACQ). Each question was scored on a scale of 0 to 6 according to the severity. The result score of each item was averaged. A score of <0.75 indicated that the asthma had been completely controlled; a score of 0.75-1.5 indicates well-controlled asthma; a score of >1.5 indicates that asthma is not controlled.	Baseline, week 4, week 6
Secondary	The change of CST1	The change of Cystatin 1	Baseline, week 4, week 6
Secondary	The change of biomarker	Changes in expression levels of biomarker in nasal brush exfoliated cells, nasal secretions and nasal microbes.	Baseline, week 4, week 6
Secondary	The change in AE / SAE recording	Any adverse event	Baseline, week 4, week 6
Secondary	The change of inflammatory cell	The change of inflammatory cell in nasal polyps	week 4, week 6
Secondary	The change of serum cortisol	The change of serum cortisol level	Baseline, week 4, week 6