Back to resultsCST1 Predictive Model of Oral Glucocorticoid Therapy Sensitivity for Chronic Rhinosinusitis With Polyps
Primary Purpose
Chronic Rhinosinusitis With Nasal Polyps, Glucocorticoids
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Oral Glucocorticoids
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Rhinosinusitis With Nasal Polyps
Eligibility Criteria
Inclusion Criteria:
- All meet the diagnostic criteria of CRSwNP in EPOS2020 (Age 18-70 years old);
- Investigator-assessed endoscopic bilateral Nasal Polyp Size Score (NPSS) was greater than or equal to 4 (minimum score of 2 per nasal cavity);
Exclusion Criteria:
- Oral glucocorticoid contraindications, such as diabetes, femoral head necrosis, gastric ulcer, etc.
- Medication history of oral glucocorticoids or immunomodulator within 1 months before enrollment, antibiotics within 2 weeks;
- fungal sinusitis, allergic fungal sinusitis (AFRS), cystic fibrosis, primary ciliary dyskinesia
Sites / Locations
- Beijing Tongren Hospital, Capital Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Oral Glucocorticoids group
Arm Description
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.
Outcomes
Primary Outcome Measures
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.)
Secondary Outcome Measures
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).
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.
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.
The change of CST1
The change of Cystatin 1
The change of biomarker
Changes in expression levels of biomarker in nasal brush exfoliated cells, nasal secretions and nasal microbes.
The change in AE / SAE recording
Any adverse event
The change of inflammatory cell
The change of inflammatory cell in nasal polyps
The change of serum cortisol
The change of serum cortisol level
Full Information
NCT ID
NCT05598424
First Posted
October 25, 2022
Last Updated
March 9, 2023
Sponsor
Beijing Tongren Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05598424
Brief Title
CST1 Predictive Model of Oral Glucocorticoid Therapy Sensitivity for Chronic Rhinosinusitis With Polyps
Official Title
Establishment of CST1 Predictive Model of Oral Glucocorticoid Therapy Sensitivity for Chronic Rhinosinusitis With Polyps
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 22, 2022 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Tongren Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinosinusitis With Nasal Polyps, Glucocorticoids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oral Glucocorticoids group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Oral Glucocorticoids
Other Intervention Name(s)
methylprednisolone
Intervention Description
Oral Glucocorticoids（methylprednisolone） 24mg qd, 2-week duration
Primary Outcome Measure Information:
Title
The change in endoscopic polyp score
Description
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
Secondary Outcome Measure Information:
Title
The change in Total Nasal Symptom Score
Description
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
Title
The change in SNOT-22 score
Description
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
Title
The change in asthma ACQ Score
Description
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
Title
The change of CST1
Description
The change of Cystatin 1
Time Frame
Baseline, week 4, week 6
Title
The change of biomarker
Description
Changes in expression levels of biomarker in nasal brush exfoliated cells, nasal secretions and nasal microbes.
Time Frame
Baseline, week 4, week 6
Title
The change in AE / SAE recording
Description
Any adverse event
Time Frame
Baseline, week 4, week 6
Title
The change of inflammatory cell
Description
The change of inflammatory cell in nasal polyps
Time Frame
week 4, week 6
Title
The change of serum cortisol
Description
The change of serum cortisol level
Time Frame
Baseline, week 4, week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All meet the diagnostic criteria of CRSwNP in EPOS2020 (Age 18-70 years old);
Investigator-assessed endoscopic bilateral Nasal Polyp Size Score (NPSS) was greater than or equal to 4 (minimum score of 2 per nasal cavity);
Exclusion Criteria:
Oral glucocorticoid contraindications, such as diabetes, femoral head necrosis, gastric ulcer, etc.
Medication history of oral glucocorticoids or immunomodulator within 1 months before enrollment, antibiotics within 2 weeks;
fungal sinusitis, allergic fungal sinusitis (AFRS), cystic fibrosis, primary ciliary dyskinesia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lou Zhang
Phone
+86-13910830399
Email
dr.luozhang@139.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luo Zhang
Organizational Affiliation
Beijing Tongren Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Tongren Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luo Zhang
Phone
+86-13910830399
Email
dr.luozhang@139.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
CST1 Predictive Model of Oral Glucocorticoid Therapy Sensitivity for Chronic Rhinosinusitis With Polyps
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