Bilateral chronic rhinosinusitis with nasal polyps (CRSwNP)
Conditions
Interventions
Experimental group:Using mometasone furoate nasal spray as background medication for treatment
control group:Using mometasone furoate nasal spray as background medication for treatment
Sponsors
Eye & ENT hospital of Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Signed informed consent form prior to trial participation, demonstrating full understanding of trial objectives, procedures, and potential adverse reactions. 2.Age between 18 and 75 years (inclusive) at the time of informed consent signing, regardless of gender. 3.Diagnosis of bilateral chronic rhinosinusitis with nasal polyps (CRSwNP) meeting the diagnostic criteria of the "Chinese Guidelines for the Diagnosis and Treatment of Chronic Rhinosinusitis (2018)"; 4.At least one prior course of systemic corticosteroids (prednisone 0.5-1 mg/kg/day or 15-30 mg/day or equivalent for minimum 5 days) within 2 years before screening, with persistent bilateral CRSwNP; AND/OR contraindication/intolerance to systemic corticosteroids; AND/OR prior nasal polyp surgery performed more than 6 months before screening. 5.Bilateral Nasal Polyp Score (NPS) >= 5 (maximum score 8) with >= 2 points per nostril, as assessed by nasal endoscopy during screening and randomization. 6.Nasal Congestion Score (NCS) >= 2 at screening (daily average) and randomization (weekly average). 7.Persistent symptoms of rhinorrhea and/or hyposmia/anosmia for over 8 weeks prior to screening. 8.22-item Sino-Nasal Outcome Test (SNOT-22) score >= 30 at screening and randomization. 9.Stable dose of intranasal corticosteroids (INCS) for >4 weeks prior to screening (subjects using non-mometasone furoate nasal spray [MFNS] products must agree to switch to MFNS during the study). 10.Documented asthma evidence meeting either criterion: >= 12% and >= 200mL absolute improvement in FEV1 and/or FVC reversibility within 12 months before Visit 1, or >= 12% and >= 200mL absolute improvement post-bronchodilator (albuterol 4 puffs) during screening (15-30 minutes post-dose). 11.For asthmatic subjects: stable symptoms for >= 4 weeks pre-screening (if medicated, inhaled corticosteroid doses must be stable for >= 4 weeks at 70% for MFNS and daily symptom diary completion >70% (missing diary days count as non-compliance). 13.Agreement to practice effective non-pharmacologic contraception from informed consent until 6 months post-final dose, for subjects/partners of childbearing potential.
Exclusion criteria
Exclusion criteria: 1.Conditions/Diseases Affecting Efficacy Evaluation 1)Nasal septum deviation causing >= 1 nostril obstruction; 2)Acute sinusitis, nasal infection, or upper respiratory infection within 2 weeks pre-screening or during screening/run-in periods; 3)Rhinitis medicamentosa; 4)Eosinophilic granulomatosis with polyangiitis (EGPA), granulomatosis with polyangiitis (GPA), Young’s syndrome, Kartagener’s syndrome, other ciliary dyskinesia syndromes, or cystic fibrosis; 5)Suspected or confirmed fungal sinusitis by imaging; 6)Prior nasal surgery altering lateral wall structure precluding NPS assessment; 7)Nasal malignancies or benign tumors (e.g., papilloma, hemangioma); 2.Any intranasal and/or sinus surgery (including polypectomy) within 6 months prior to screening. 3.Uncontrolled epistaxis within 2 months prior to screening. 4.Regular use of decongestants (topical or systemic) prior to screening, except for short-term use during endoscopic examinations. 5.Patients who have received any of the following treatments prior to screening: 1)Treatment with immunosuppressants (including but not limited to: cyclophosphamide, cyclosporine, interferon gamma, azathioprine, methotrexate, mycophenolate, tacrolimus) within 8 weeks or 5 half-lives prior to screening (whichever is longer); 2)Treatment with any monoclonal antibodies (including but not limited to: benralizumab, mepolizumab, omalizumab, dupilumab, or other similar drugs [e.g., TSLP blockers]) within 8 weeks or 5 half-lives prior to screening (whichever is longer). 3)Patients who used medium- or short-acting systemic corticosteroids (SCS, including oral, intravenous, or intramuscular administration), systemic traditional Chinese medicine preparations for treating CRS within 4 weeks prior to screening, or received long-acting SCS (e.g., triamcinolone acetonide injection) within 6 weeks prior to screening, or who plan to receive the aforementioned medications during the study period. 4)Use of corticosteroid-eluting nasal stents within 6 months prior to screening; 5)Treatment with immunoglobulins or blood products within 28 days prior to screening; 6)Administration of live attenuated vaccines within 28 days prior to screening or planned during the study period; 7)Allergen-specific immunotherapy within 6 months prior to screening (allowed only if: initiated >3 months before screening, maintained at a stable dose for >= 1 month before Visit 1, and no planned dose changes during the study); 8)Participation in other drug/medical device clinical trials within 3 months prior to screening (based on last administration/use). 6.Screening for a history of active pulmonary tuberculosis within the past 12 months; 7.Exclusion of infections within the last 14 days requiring systemic antibiotic, antiviral, antifungal, antiparasitic, or antiprotozoal therapy; 8.Exclusion of subjects diagnosed with helminthic parasitic infection in the past 6 months who either did not receive standard treatment or had treatment failure; 9.Known or suspected history of immunosuppression, immune dysfunction, or immune dysregulation, including but not limited to invasive opportunistic infections (histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis), even if the infection has resolved; 10.Patients with comorbid asthma who meet any of the following criteria: Pre-bronchodilator forced expiratory volume in 1 second (FEV1) <= 50% of the predicted normal value, or Asthma exacerbation within 90 days before screening, or c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Nasal Polyp Score (NPS);Change in Nasal Congestion Score (NCS); | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics;Lund-Mackay score;Visual Analog Scale (VAS);Pharmacodynamics;Change in Nasal Polyp Score (NPS);22-item Sino-Nasal Outcome Test (SNOT-22) score;Receive systemic corticosteroids (SCS) rescue or nasal polyp (NP) surgery;Evaluate the immunogenicity of TQC2731;Total Symptom Score (TSS);Olfactory loss score;Evaluate the safety of TQC2731 in subjects with CRSwNP;Change in Nasal Congestion Score (NCS);Receive systemic corticosteroids (SCS) rescue or nasal polyp (NP) surgery; | — |
Countries
China
Contacts
Public ContactWang Dehui
Eye & ENT hospital of Fudan University
Outcome results
None listed