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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
methylprednisolone 24mg qd, 2-week duration
oral placebo 24mg qd, 2-week duration
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
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.)
Time frame: Baseline, week 2, week 6, week 10, week 14, week 18, week 22, week 26
The change in Total Nasal Symptom Score(TNSS)
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 2, week 6, week 10, week 14, week 18, week 22, week 26
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 2, week 6, week 10, week 14, week 18, week 22, week 26
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 2, week 6, week 10, week 14, week 18, week 22, week 26
The change of CST1
The change of Cystatin 1
Time frame: Baseline, week 2, week 6, week 10, week 14, week 18, week 22, week 26
The change of biomarker
Changes in expression levels of biomarker in nasal brush exfoliated cells, nasal secretions and nasal microbes.
Time frame: Baseline, week 2, week 6, week 10, week 14, week 18, week 22, week 26
The change in AE / SAE recording
Any adverse event
Time frame: Baseline, week 2, week 6, week 10, week 14, week 18, week 22, week 26
The needs of upgrading treatment
The needs of upgrading treatment includes surgery, oral glucocorticoids or monoclonal antibodies treatment.
Time frame: Baseline, week 2, week 6, week 10, week 14, week 18, week 22, week 26
The change of inflammatory cell
The change of inflammatory cell in nasal polyps
Time frame: Baseline, week 2, week 26
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