Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Glucocorticoids group | Experimental | Intervention Period:oral glucocorticoids(methylprednisolone 24mg qd, 2-week duration)+nasal spray (Budesonide Nasal Spray 64ug per Nostril, bid, 2-week duration) follow-up period:nasal spray(Budesonide Nasal Spray 64ug per Nostril, bid, 24-week duration) |
|
| Placebo group | Placebo Comparator | Intervention Period:oral placebo+nasal spray(oral placebo 24mg qd, 2-week duration)+nasal spray (Budesonide Nasal Spray 64ug per Nostril, bid, 2-week duration) follow-up period:nasal spray(Budesonide Nasal Spray 64ug per Nostril, bid, 24-week duration) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Glucocorticoids | Drug | methylprednisolone 24mg qd, 2-week duration |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 2, week 6, week 10, week 14, week 18, week 22, week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, week 2, week 6, week 10, week 14, week 18, week 22, week 26 |
| The change in SNOT-22 score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lou Zhang | Contact | +86-13910830399 | dr.luozhang@139.com |
| Name | Affiliation | Role |
|---|---|---|
| Luo Zhang | Beijing Tongren Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital, Capital Medical University | Beijing | Beijing Municipality | 100000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005938 | Glucocorticoids |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Oral placebo | Drug | oral placebo 24mg qd, 2-week duration |
|
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 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. | Baseline, week 2, week 6, week 10, week 14, week 18, week 22, week 26 |
| The change of CST1 | The change of Cystatin 1 | 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. | Baseline, week 2, week 6, week 10, week 14, week 18, week 22, week 26 |
| The change in AE / SAE recording | Any adverse event | 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. | 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 | Baseline, week 2, week 26 |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |