Clinical trial NCT05598411: CST1-Guided Oral Glucocorticoids Management for CRSwNP
Official title: Efficacy of CST1-Guided Oral Glucocorticoid Therapy for Chronic Rhinosinusitis With Polyps
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Chronic Rhinosinusitis With Nasal Polyps
Glucocorticoids
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Age 18-70 years old；
2. All meet the diagnostic criteria of CRSwNP in EPOS2020;
3. Investigator-assessed endoscopic bilateral Nasal Polyp Size Score (NPSS) was greater than or equal to 4 (minimum score of 2 per nasal cavity);
4. Patients with asthma were in a stable state, with FEV1 \> 50% of the predicted value or 50% of the optimal value of personal FEV1; (5) Good compliance, able to complete clinical observation.

Exclusion Criteria:

1. Medication history of oral glucocorticoids within 3 months before enrollment, antibiotics within 2 weeks;
2. Oral glucocorticoid contraindications, such as diabetes, femoral head necrosis, gastric ulcer, etc.;
3. Any nasal and/or sinus surgery within 3 months before enrollment;
4. Patients have conditions or comorbidities that may preclude evaluation of the primary efficacy endpoint, such as: unilateral posterior nasal polyp of maxillary sinus, acute rhinitis, nasal infection or upper respiratory tract at the screening period or within 2 weeks before the screening period infection, acute asthma attack within 4 weeks, current drug-induced rhinitis, allergic fungal sinusitis (AFRS), benign or malignant tumor of nasal cavity；
5. Important clinical comorbidities that may interfere with clinical effectiveness, including but not limited to: active upper or lower respiratory tract infection, cystic fibrosis, eosinophilic granuloma with polyvasculitis (Churg-Strauss syndrome), granulomatosis with polyangiitis (Wegener's granulomatosis), Young's syndrome, etc.;
6. Accompanying serious diseases or recurrent chronic diseases with poor systemic control, such as (but not limited to), active infection, cardiovascular disease, tuberculosis or other pathogen infection, diabetes, autoimmune disease, HIV, hepatitis B, Hepatitis C or parasitic diseases, malignant tumors, etc.;
7. Subjects with severe liver and kidney function injury; such as, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \>2 times the upper limit of normal, serum creatinine \> the upper limit of normal value;
8. Known or suspected immunosuppression, including a history of invasive opportunistic infections (such as tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pulmonary cysts, aspergillosis), even if the infection has subsided;
9. Women who were pregnant or planned to become pregnant during the study, or who were breastfeeding;
10. Subjects who were fertile but were reluctant to use medically approved and effective contraception;
11. Those with a history of alcohol or drug abuse;
12. Those who believed the patient had other medical or non-medical conditions that were not suitable for the study.

Primary outcomes:
measure: The change in endoscopic polyp score
timeFrame: Baseline, week 2, week 6, week 10, week 14, week 18, week 22, week 26
Secondary outcomes:
measure: The change in Total Nasal Symptom Score（TNSS）
timeFrame: Baseline, week 2, week 6, week 10, week 14, week 18, week 22, week 26
measure: The change in SNOT-22 score
timeFrame: Baseline, week 2, week 6, week 10, week 14, week 18, week 22, week 26
measure: The change in asthma ACQ Score
timeFrame: Baseline, week 2, week 6, week 10, week 14, week 18, week 22, week 26
measure: The change of CST1
timeFrame: Baseline, week 2, week 6, week 10, week 14, week 18, week 22, week 26
measure: The change of biomarker
timeFrame: Baseline, week 2, week 6, week 10, week 14, week 18, week 22, week 26
measure: The change in AE / SAE recording
timeFrame: Baseline, week 2, week 6, week 10, week 14, week 18, week 22, week 26
measure: The needs of upgrading treatment
timeFrame: Baseline, week 2, week 6, week 10, week 14, week 18, week 22, week 26
measure: The change of inflammatory cell
timeFrame: Baseline, week 2, week 26
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tongren Hospital
name: Luo Zhang
role: STUDY_CHAIR
References: