Establishment of Precise Diagnosis and Treatment System for Refractory Chronic Rhinosinusitis
Status:
Recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
Summary
Chronic rhinosinusitis that recurs after adequate surgery and conventional medical treatment
is called refractory chronic rhinosinusitis (RCRS). Omalizumab and oral glucocorticoid
therapy can play an important role in the treatment of RCRS, but there is still a lack of
comparative studies on the efficacy and safety of the two. In addition, biomarkers are a
hotspot in RCRS research, but there is still a lack of studies on changes in marker
expression with disease progression and treatment.
In this study, patients aged 18-70 who were diagnosed with CRS were consecutively enrolled,
and the patients were divided into RCRS and non-RCRS groups according to pathological
results. The patients in the RCRS group were randomly divided (1:1:1) into the nasal spray
hormone therapy group, the nasal spray hormone therapy + oral hormone therapy group, and the
nasal spray hormone therapy + omalizumab therapy group by a multi-center, randomized,
controlled study. The patients were treated for 6 months and followed up for 6 months after
treatment. Clinical data such as symptom score and endoscopic score before and after
treatment were collected, adverse events were recorded, and the differences in efficacy and
safety among the groups were compared. Non-invasive samples such as nasal secretions and
exfoliated cells were collected, and the expression and variation of different immune
intrinsic markers were explored combined with follow-up results. The development of this
project contributes to the establishment of a precise diagnosis and treatment system for
refractory chronic sinusitis.
Phase:
Phase 3
Details
Lead Sponsor:
Beijing Tongren Hospital
Collaborators:
Beijing Hospital Peking Union Medical College Hospital