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NCT05390255
Establishment of Precise Diagnosis and Treatment System for Refractory Chronic Rhinosinusitis
Phase 3 trial testing Mometasone furoate nasal spray hormone in Sinusitis in 87 participants. Status unknown.
31 December 2024
Quick facts
| Lead sponsor | Beijing Tongren Hospital |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 87 |
| Start date | 25 May 2022 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 December 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Mometasone furoate nasal spray hormone — full drug profile →
- Mometasone furoate nasal spray hormone + oral hormone — full drug profile →
- Mometasone furoate nasal spray hormone + omalizumab — full drug profile →
Conditions studied
- Sinusitis — all drugs for Sinusitis →
Sponsor
Beijing Tongren Hospital
Who can join
Adults 18 to 70, any sex, with Sinusitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Chinese Position Paper on Biologic Therapy for Chronic Rhinosinusitis With Nasal Polyps.
Xian M, Yan B, Song X, Chen J, et al · · 2025 · cited 6× · PMID 40042059 · DOI 10.1111/all.16519
Verify or expand the search:
- PubMed search for NCT05390255
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05390255 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Beijing Tongren Hospital
- Last refreshed: 25 May 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05390255.
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