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450 subjects with moderate-severe persistent allergic rhinitis will be enrolled in the trial and divided into three groups for different treatments. Group A:Subjects with Bencycloquidium Bromide Nasal Spray, Group B:Subjects with Mometasone Furoate Aqueous Nasal Spray, Group C:Subjects with Bencycloquidium Bromide Nasal Spray in combination with Mometasone Furoate Aqueous Nasal Spray.The main purpose of the trial is to evaluate the efficacy of Bencycloquidium Bromide Nasal Spray alone or in combination with Mometasone Furoate Aqueous Nasal Spray in the treatment of moderate-severe persistent allergic rhinitis and rhinorrhea.
The Secondary purpose is to evaluate the effectiveness of Bencycloquidium Bromide Nasal Spray alone or in combination with Mometasone Furoate Aqueous Nasal Spray in the treatment of moderate-severe persistent allergic rhinitis with nasal itching, nasal congestion, and sneezing. And evaluate the safety of Bencycloquidium Bromide Nasal Spray alone or in combination with Mometasone Furoate Aqueous Nasal Spray.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bencycloquidium Bromide | Experimental | Bencycloquidium Bromide Nasal Spray (90μg per spray):1 spray on each nostril, 4times per day, continuous treatment for 4 weeks (28days). |
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| Mometasone Furoate Aqueous | Active Comparator | Mometasone Furoate Aqueous Nasal Spray (50μg per spray):2 sprays on each nostril, 1 time per day, continuous treatment for 4 weeks (28days). |
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| Bencycloquidium Bromide with Mometasone Furoate Aqueous | Experimental | Bencycloquidium Bromide Nasal Spray in combination with Mometasone Furoate Aqueous Nasal Spray: For Bencycloquidium Bromide Nasal Spray(90μg per spray), 1 spray on each nostril, 4times per day. For Mometasone Furoate Aqueous Nasal Spray (50μg per spray), 2 sprays on each nostril, 1 time per day. If there is an overlap between the two drugs, use Bencycloquidium Bromide Nasal Spray first, and then mometasone furoate nasal spray should be used after an interval of more than 30 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bencycloquidium Bromide Nasal Spray | Drug | The content of this product is a colorless and clear liquid, press the sprayer, the liquid will be sprayed out in mist. This product is suitable for improving the symptoms of runny nose, nasal congestion, nasal itching and sneezing caused by allergic rhinitis. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | adverse clinical events that occur during drug treatment, which may not have a causal relationship with the drug. | From the start of the enrollment to the end of the study, an average of 35days |
| Symptom scores of runny nose | It is the symptom scores of runny nose, based on a 4-point method: 0 points: asymptomatic;
| immediately after the final intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale score of runny nose,nasal congestion, nasal itching, and sneezing | Visual Analysis Scale (VAS, Visual Analysis Scale) score, from 0 to 10 points, the total symptoms of nasal congestion, nasal itching, and sneezing gradually increase; 0 of which is asymptomatic; 3 and below 3-the symptoms are mild and can be tolerated; 4 to 6 - the symptoms are severe but tolerable; 7 to 10 -symptoms are severe and unbearable, which affect appetite and sleep. The subjects calibrate it according to the intensity of the symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luo Zhang, Doctor | Beijing Tongren Hospital,CMU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing friendship hospital, CMU | Beijing | Beijing Municipality | China | |||
| Beijing Shijitan Hospital,CMU |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39746515 | Derived | Li X, Wang X, Yang Q, Chen J, Tian H, Lu M, Ma T, Zhang Y, Zhou Y, Xia J, Cheng L, Zhang Y, Zhang L. A Randomized Comparison of Bencycloquidium Bromide, Mometasone Furoate, and a Combination for Persistent Allergic Rhinitis. J Allergy Clin Immunol Pract. 2025 Mar;13(3):670-679.e3. doi: 10.1016/j.jaip.2024.12.035. Epub 2024 Dec 31. |
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450 subjects with moderate-severe persistent allergic rhinitis will be enrolled in the trial and divided into three groups for different treatment.
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| Mometasone Furoate Aqueous Nasal Spray | Drug | Mometasone furoate nasal spray is a quantitative hand-press spray device, and the content is a white to off-white suspension. This product is suitable for the treatment of seasonal or perennial rhinitis in adults, adolescents and children from 3 to 11 years old. For patients who have had moderate to severe seasonal allergic rhinitis symptoms, it is recommended to use this product 2-4 weeks before the start of the pollen season Preventive treatment. |
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| immediately after the final intervention |
| Visual Analogue Scale score of total nasal symptoms | 24-hour retrospective review of the average change in the Visual Analogue Scale score of total nasal symptoms compared to the baseline. From 0 to 10 points, 0 of which is asymptomatic; 3 and below 3-the symptoms are mild and can be tolerated; 4 to 6 - the symptoms are severe but tolerable; 7 to 10 -symptoms are severe and unbearable, which affect appetite and sleep. The subjects calibrate it according to the intensity of the symptoms | immediately after the final intervention |
| Total Nasal Symptom Scores and Drug score | Total nose symptom TNSS(Total Nasal Symptom Scores): It is the sum of 4 individual symptom scores of runny nose, nasal congestion, nasal itching and sneezing, totaling 12 points, and each symptom score is based on a 4-point method: 0 points: asymptomatic;
Drug score: 0 points: No other drugs used to treat Allergic Rhinitis;
| immediately after the final intervention |
| The questionnaire of patient with global impression of change | the subject's overall impression of symptoms change. From 0 to 4: 0 points: not evaluated;
| immediately after the final intervention |
| The questionnaire of Rhinoconjunctivitis Quality of Life | the quality of sleep, symptoms of eyes, feelings of emotions due to the influence of nasal symptoms. From 0-6: 0-1 points: almost asymptomatic; 2-3 point: mild symptoms (symptoms are mild and easy to tolerate); 4-5 points: moderate symptoms (significant symptoms, annoying, but tolerable); 6 points: Severe symptoms | immediately after the final intervention |
| Beijing |
| Beijing Municipality |
| China |
| Beijing Tongren Hospital,CMU | Beijing | Beijing Municipality | China |
| The third affliation hospital of Sun YAT-SEN university | Guangzhou | Guangdong | China |
| Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology | Wuhan | Hubei | China |
| Jiangsu Province hospital | Nanjing | Jiangsu | China |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068656 | Mometasone Furoate |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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