Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07795658

China CRSwNP Registry Study

Sponsor: Beijing Tongren Hospital

View on ClinicalTrials.gov

Summary

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a long-lasting inflammatory disease of the nose and sinuses that can cause nasal blockage, loss of smell, nasal discharge, facial discomfort, sleep problems, and reduced quality of life. POLARIS is a prospective, multicenter, real-world, non-interventional registry study. It will enroll approximately 1,000 adolescents and adults aged 12 years or older with bilateral CRSwNP at about 33 centers in China and follow them for 36 months. All treatment decisions will be made by the treating physicians according to routine clinical practice. The study will not assign participants to any treatment. The study aims to describe the disease burden, underlying inflammatory characteristics, real-world treatment patterns, effectiveness of current treatments, and long-term outcomes of Chinese patients with CRSwNP. Key assessments will include changes in nasal symptoms measured by the Total Nasal Symptom Score, changes in disease-related quality of life measured by the 22-item Sino-Nasal Outcome Test, and the proportions of patients classified as cured, controlled, or uncontrolled at months 12, 24, and 36. The study will also examine treatment escalation, surgery, systemic corticosteroid and biologic use, health care and economic burden, safety events, and clinical characteristics and biomarkers associated with persistent high disease burden or frequent treatment escalation.

Official title: POLARIS: A Prospective, Multicenter Real-World Study to Investigate the Treatment Pattern and Prognostic Outcome in Chinese Severe Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Patients

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2026-10-31

Completion Date

2030-12-31

Last Updated

2026-08-31

Healthy Volunteers

No

Interventions

OTHER

Routine Clinical Care for CRSwNP

Participants may receive any clinically indicated treatment for CRSwNP according to routine clinical practice, including intranasal corticosteroids, systemic corticosteroids, endoscopic sinus surgery, biologic therapies, and other appropriate management. Treatment selection, initiation, switching, discontinuation, and escalation are determined by the treating physicians. The study does not provide or assign any treatment; it observes real-world treatment patterns and associated clinical outcomes over 36 months.

Locations (1)

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, China