A Phase 3 interventional study of Mometasone furoate nasal spray hormone and Mometasone furoate nasal spray hormone + oral hormone in Sinusitis, sponsored by Beijing Tongren Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-05-25.
Sponsored by Beijing Tongren Hospital · Phase 3, Interventional, and Treatment
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.
330 studies on the registry are indexed under Rhinosinusitis; 55 are open to participants now.
This study's planned enrollment of 87 is above the median of 60 across 227 interventional studies indexed under Rhinosinusitis.
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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.
Drug: Mometasone furoate nasal spray hormone
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.
Drug: Mometasone furoate nasal spray hormone + oral hormone
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.
Drug: Mometasone furoate nasal spray hormone + omalizumab
This group of patients received mometasone furoate nasal spray hormone treatment throughout the study.
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.
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.
The change in endoscopic 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.)
Time frame: Baseline, week 2, week 4, week 8, week 12, week 14, week 16, week 20, week 24, month 9, month 12
The change in nasal symptoms
Nasal symptom was assessed using the Visual Analog Scale (VAS). The symptoms are graded on a 10-point scale (0 = no symptoms; 10 = most severe symptoms).
Time frame: Baseline, week 2, week 4, week 8, week 12, week 14, week 16, week 20, week 24, month 7, month 8, month 9, month 10, month 11,month 12
The change in sinus CT score
The Lund-Mackay imaging scoring system was used for the CT scan results of the sinuses (0, 1, and 2 were used for each frontal sinus, anterior ethmoid sinus, posterior ethmoid sinus, maxillary sinus, and sphenoid sinus, indicating no opacity, partial opacity and all turbidity of the sinus cavity respectively; 0 and 2 were used for each side of the sinus complex to indicate no blockage and presence of blockage) to calculate the total score and E/M value (bilateral ethmoid total score/bilateral maxillary sinus total score), etc.
Time frame: Baseline, week 24
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.
Time frame: Baseline, week 2, week 4, week 8, week 12, week 14, week 16, week 20, week 24, month 7, month 8, month 9, month 10, month 11,month 12
The change in exfoliated cells and secretions
Changes in expression levels of T1, T2, T3 factors and T2 inflammatory markers CST1 and CLC in nasal brush exfoliated cells and nasal secretions.
Time frame: Baseline, week 2, week 4, week 8, week 12, week 14, week 16, week 20, week 24, month 9,month 12
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.
Time frame: Baseline, week 2, week 4, week 8, week 12, week 14, week 16, week 20, week 24, month7, month 8, month 9, month 10, month 11, month 12
The change in AE / SA recording
Time frame: Baseline, week 2, week 4, week 8, week 12, week 14, week 16, week 20, week 24, month7, month8, month 9, month 10, month 11, month 12
The change in serum cortisol
Time frame: Baseline, week 24
Plan to share: No
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Beijing Tongren Hospital