NCT05598424

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2022

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2022

Completed
25 days until next milestone

Study Start

First participant enrolled

November 22, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

March 10, 2023

Status Verified

March 1, 2023

Enrollment Period

2.1 years

First QC Date

October 25, 2022

Last Update Submit

March 9, 2023

Conditions

Chronic Rhinosinusitis With Nasal PolypsGlucocorticoids

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 4, week 6

Secondary Outcomes (8)

  • The change in Total Nasal Symptom Score

    Baseline, week 4, week 6

  • The change in SNOT-22 score

    Baseline, week 4, week 6

  • The change in asthma ACQ Score

    Baseline, week 4, week 6

  • The change of CST1

    Baseline, week 4, week 6

  • The change of biomarker

    Baseline, week 4, week 6

  • +3 more secondary outcomes

Study Arms (1)

Oral Glucocorticoids group

EXPERIMENTAL

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

Interventions

Oral GlucocorticoidsDRUG

Oral Glucocorticoids（methylprednisolone） 24mg qd, 2-week duration

Also known as: methylprednisolone
Oral Glucocorticoids group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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);

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Interventions

GlucocorticoidsMethylprednisolone

Intervention Hierarchy (Ancestors)

Adrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesPrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Luo Zhang

    Beijing Tongren Hospital

    STUDY CHAIR

Central Study Contacts

Lou Zhang

CONTACT

+86-13910830399dr.luozhang@139.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2022

First Posted

October 28, 2022

Study Start

November 22, 2022

Primary Completion

December 30, 2024

Study Completion

November 1, 2025

Last Updated

March 10, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)