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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Oral Glucocorticoids（methylprednisolone） 24mg qd, 2-week duration
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGThe 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.)
Time frame: Baseline, week 4, week 6
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).
Time frame: Baseline, week 4, week 6
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.
Time frame: Baseline, week 4, week 6
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.
Time frame: Baseline, week 4, week 6
The change of CST1
The change of Cystatin 1
Time frame: Baseline, week 4, week 6
The change of biomarker
Changes in expression levels of biomarker in nasal brush exfoliated cells, nasal secretions and nasal microbes.
Time frame: Baseline, week 4, week 6
The change in AE / SAE recording
Any adverse event
Time frame: Baseline, week 4, week 6
The change of inflammatory cell
The change of inflammatory cell in nasal polyps
Time frame: week 4, week 6
The change of serum cortisol
The change of serum cortisol level
Time frame: Baseline, week 4, week 6
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