A Phase 4 interventional study of Oral Glucocorticoids in Chronic Rhinosinusitis With Nasal Polyps and Glucocorticoids, sponsored by Beijing Tongren Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-03-10.
Sponsored by Beijing Tongren Hospital · Phase 4, Interventional, and Treatment
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.
Exclusion Criteria:
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.
Drug: Oral Glucocorticoids
Oral Glucocorticoids（methylprednisolone） 24mg qd, 2-week duration
Also known as: methylprednisolone
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 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
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Beijing Tongren Hospital