Establishment of Precise Diagnosis and Treatment System for Refractory Chronic Rhinosinusitis

Sponsor
Beijing Tongren Hospital
Study ID
NCT05390255
Phase
PHASE3
Status
Unknown

Conditions

  • Sinusitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Mometasone furoate nasal spray hormone — DRUG
    This group of patients received mometasone furoate nasal spray hormone treatment throughout the study.
  • Mometasone furoate nasal spray hormone + oral hormone — DRUG
    The patients in this group were given oral hormone therapy for 14 days in the first month and the fourth month under the background of mometasone furoate nasal spray hormone treatment throughout the course.
  • Mometasone furoate nasal spray hormone + omalizumab — DRUG
    The patients in this group were injected with omalizumab once a month under the background of mometasone furoate nasal spray hormone treatment, for a total of 6 times.

Study Details

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.

Key Dates

Start date
May 25, 2022
Status verified
May 2022
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
87 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nasal spray hormone therapy
    This group of patients received nasal steroid therapy throughout the study. The clinical data of patients at baseline and each visit period were collected, the incidence of adverse events was recorded, and the short-term efficacy and safety of different drug treatment regimens were evaluated.
  • Experimental: Nasal spray hormone therapy + oral hormone therapy
    The patients in this group were given oral hormone therapy for 14 days in the first month and the fourth month under the background of nasal spray hormone treatment throughout the course. The clinical data of patients at baseline and each visit period were collected, the incidence of adverse events was recorded, and the short-term efficacy and safety of different drug treatment regimens were evaluated.
  • Experimental: Nasal spray hormone therapy + omalizumab therapy
    The patients in this group were injected with omalizumab once a month under the background of nasal spray hormone therapy, for a total of 6 times. The clinical data of patients at baseline and each visit period were collected, the incidence of adverse events was recorded, and the short-term efficacy and safety of different drug treatment regimens were evaluated.

Primary Outcome Measure

The change in endoscopic score [ Time Frame: Baseline, week 2, week 4, week 8, week 12, week 14, week 16, week 20, week 24, month 9, month 12 ]

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