CST1-Guided Oral Glucocorticoids Management for CRSwNP

NCT05598411 | Unknown Phase 4 DMC

• 1 other identifier: TR-COMPASS
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Rhinosinusitis With Nasal Polyps; Glucocorticoids

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• The change in Total Nasal Symptom Score（TNSS）

  Baseline, week 2, week 6, week 10, week 14, week 18, week 22, week 26

• The change in SNOT-22 score

  Baseline, week 2, week 6, week 10, week 14, week 18, week 22, week 26

• The change in asthma ACQ Score

  Baseline, week 2, week 6, week 10, week 14, week 18, week 22, week 26

• The change of CST1

  Baseline, week 2, week 6, week 10, week 14, week 18, week 22, week 26

• The change of biomarker

  Baseline, week 2, week 6, week 10, week 14, week 18, week 22, week 26

Study Arms (2)

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）

Drug: Oral Glucocorticoids

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）

Drug: Oral placebo

Interventions

Oral Glucocorticoids DRUG

methylprednisolone 24mg qd, 2-week duration

Also known as: methylprednisolone

Oral Glucocorticoids group

Oral placebo DRUG

oral placebo 24mg qd, 2-week duration

Placebo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years old；
• All meet the diagnostic criteria of CRSwNP in EPOS2020;
• Investigator-assessed endoscopic bilateral Nasal Polyp Size Score (NPSS) was greater than or equal to 4 (minimum score of 2 per nasal cavity);
• 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.

You may not qualify if:

• Medication history of oral glucocorticoids within 3 months before enrollment, antibiotics within 2 weeks;
• Oral glucocorticoid contraindications, such as diabetes, femoral head necrosis, gastric ulcer, etc.;
• Any nasal and/or sinus surgery within 3 months before enrollment;
• 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；
• 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.;
• 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.;
• 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;
• 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;
• Women who were pregnant or planned to become pregnant during the study, or who were breastfeeding;
• Subjects who were fertile but were reluctant to use medically approved and effective contraception;
• Those with a history of alcohol or drug abuse;
• Those who believed the patient had other medical or non-medical conditions that were not suitable for the study.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Interventions

Glucocorticoids; Methylprednisolone

Intervention Hierarchy (Ancestors)

Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Luo Zhang

  Beijing Tongren Hospital

  STUDY CHAIR

Central Study Contacts

Lou Zhang

CONTACT

+86-13910830399; dr.luozhang@139.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: October 28, 2022
• Study Start: October 17, 2022
• Primary Completion: December 30, 2024
• Study Completion: November 1, 2025
• Last Updated: October 28, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)