Seasonal Allergic Rhinitis
Conditions
Interventions
Control Group:Control Group of Rupatadine Fumarate Tablets
Placebo Group:Placebo Control Group
Experimental Group:Rupatifen Fumarate Capsules Group
Sponsors
Bejing Tongren Hospital, Capital Medical Uniersity
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 65 years old (including the boundaries), any gender; 2. Clinical diagnosis is based on the "Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2022 Revision)" issued by the Nasal Science Group of the Chinese Society of Otorhinolaryngology Head and Neck Surgery. The patient should have a clear history of at least 2 years (based on the chief complaint), and at least one positive test for any local seasonal allergen (like tree pollen, grasses, etc.) before randomization. Skin prick test (SPT), intradermal test, or specific IgE (sIgE) tests for any allergen are recognized (sIgE tests within 1 year prior to enrollment are acceptable if positive for the seasonal allergen of that time). Clinical manifestations may include: (1) Symptoms: Two or more of paroxysmal sneezing, clear runny nose, itchy nose, or nasal congestion; symptoms lasting or accumulating for 1 hour or more daily, possibly accompanied by eye symptoms like tearing, itchy eyes, or redness; (2) Signs: Common nasal mucosa pale and swollen, watery nasal discharge; (3) Allergic symptoms showing seasonal patterns in spring and/or autumn, and currently experiencing symptoms at the time of enrollment; 3. During screening, total nasal symptom score (rTNSS) >= 6, nasal congestion >= 2, and at least one of the following—runny nose, itchy nose, or sneezing—>= 2; 4. Participants are willing to sign informed consent, follow study procedures, including understanding and accurately recording the participant diary, and can understand and follow planned treatment, lab tests, and other study procedures.
Exclusion criteria
Exclusion criteria: 1.(Medical inquiry)Patients with asthma requiring long-term treatment(subjects with occasional asthmatic symptoms such as dyspnea or exercise-induced asthma who require no medication during the trial may be enrolled); 2.Subjects with infectious conjunctivitis or other ocular infections(allergic conjunctivitis excluded); 3.Subjects with concomitant nasal diseases or conditions at screening(e.g., acute/chronic sinusitis, nasal polyps, deviated nasal septum, rhinitis medicamentosa, cerebrospinal fluid rhinorrhea, status within 1 year post nasal surgery, etc.)that may interfere with efficacy assessment as judged by the investigator(self-reported history is acceptable); 4.(Medical inquiry)Active respiratory tract infection occurring within 14 days prior to screening or throughout the run-in period, including but not limited to bronchitis, pneumonia, upper respiratory tract infection or sinus infection; 5.(Medical inquiry)Subjects receiving sinus surgery within 3 months before screening or with incompletely healed nasal trauma; 6.(Medical inquiry)Severe pulmonary disease or impaired pulmonary function such as chronic obstructive pulmonary disease(COPD); 7.(Medical inquiry)Subjects with cardiac disorders requiring treatment;male subjects with QT interval corrected by Fridericia's formula(QTcF)greater than 470 ms, female subjects with QT interval corrected by Fridericia's formula(QTcF)greater than 480 ms, uncorrectable hypokalemia, progressive arrhythmias including bradycardia or acute myocardial ischemia who are deemed ineligible for enrollment per investigator's judgment; 8.(Medical inquiry)Subjects receiving allergen immunotherapy within 6 months prior to screening; 9.Subjects with severe hepatic or renal disorders, or abnormal hepatic and renal laboratory results:alanine aminotransferase(ALT)/aspartate aminotransferase(AST)>=2 times the upper limit of normal(ULN), or creatinine(Cr)>1.2 times the upper limit of normal(ULN); 10.(Medical inquiry)Inadequate washout of prohibited medications prior to screening;specified washout periods for common medicines are listed below: (1)Intranasal or systemic decongestants, anticholinergics, intranasal antihistamines:3 days; (2)Systemic antihistamines(cetirizine, fexofenadine, loratadine, desloratadine etc.):10 days; (3)Mast cell stabilizers, tricyclic antidepressants, anti-allergic herbal medicines, leukotriene receptor antagonists:2 weeks; (4)Systemic glucocorticoids:4 weeks;potent topical or intranasal glucocorticoids:2 weeks; (5)Anti-immunoglobulin E(Anti-IgE)therapy, interleukin-4(IL-4R)inhibitors(dupilumab, tezepelumab etc.):3 months or 5 elimination half-lives, whichever is longer;allergen immunotherapy:6 months; (6)For other unlisted drugs relevant to allergic rhinitis treatment in this trial:washout of no less than 5 elimination half-lives or 3 days prior to run-in period initiation, whichever is longer; 11.(Medical inquiry)Subjects unable to discontinue concomitant medications that may interfere with efficacy evaluation throughout the trial, including but not limited to tricyclic antidepressants, systemic/potent topical/intranasal glucocorticoids, decongestants(except rescue medication), antihistamines, leukotriene receptor antagonists, mast cell stabilizers(cromolyn sodium, nedocromil sodium, lodoxamide tromethamine, pemirolast potassium, tranilast etc.), central nervous system depressants, anti-immunoglobulin E(anti-IgE)agents(omalizumab), anticholinergics and anti-allergic herbal medicines, r
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the average reactive total nasal symptom score (rTNSS) during the treatment period (Day 1 to Day 15); | — |
Secondary
| Measure | Time frame |
|---|---|
| To Evaluate the Safety of Rupatifen Fumarate Capsules in the Treatment of Seasonal Allergic Rhinitis;Summarize the results of quantitative indicators at each visit and their changes from baseline by group;Change from baseline in average instantaneous Total Nasal Symptom Score (iTNSS) during the treatment period (Day 1 to Day 15); | — |
Countries
China
Contacts
Public ContactZhang Luo
Bejing Tongren Hospital, Capital Medical Uniersity
Outcome results
None listed