Study on the Efficacy and Safety of Bencycloquidium Bromide Nasal Spray Alone or in Combination With Mometasone Furoate Aqueous Nasal Spray in the Treatment of Moderate-severe Persistent Allergic Rhinitis
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 450
- 试验地点
- 6
- 主要终点
- Number of adverse events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The diagnosis of allergic rhinitis meets the standards of "Guidelines for the Diagnosis and Treatment of Allergic Rhinitis" (2015, Tianjin);
- •The previous or current symptom onset is ≥4d/week and ≥4 consecutive weeks; the symptoms are severe or serious (Total Nasal Symptom Scores≥6 points) with single symptom score of runny nose ≥2 points;
- •Able to complete the symptom score as required;
- •Subjects voluntarily participate in this study, and sign a written informed consent form. Use study drugs, complete evaluation and follow-up in accordance with the requirements of this study.
排除标准
- •Those who are known to be allergic to the ingredients contained in test drugs.
- •Used vasoconstrictors within 1 day; used topical or oral antihistamines within 3 days; used topical glucocorticoids and leukotriene receptor antagonists within 7 days; used oral glucocorticoid drugs within 30 days.
- •Those who have been diagnosed as asthma or have asthma symptoms (wheezing, shortness of breath, chest tightness, coughing).
- •Patients suffering from respiratory infections or abnormal nasal anatomy (such as nasal polyps, nasal septum deviation, etc.) one month before enrollment.
- •Received immunotherapy and nasal surgery Within 6 months before enrollment.
- •Patients with dry eye.
- •Patients with glaucoma.
- •Patients with enlarged prostate who have difficulty urinating.
- •People with mental disorders or impaired consciousness.
- •Pregnancy (patients report pregnancy), those who have a pregnancy plan within 6 months, and lactating women.
- •Patients considered by the researcher to be unsuitable to participate in this study.
研究组 & 干预措施
Bencycloquidium Bromide
Bencycloquidium Bromide Nasal Spray (90μg per spray)：1 spray on each nostril, 4times per day, continuous treatment for 4 weeks (28days).
干预措施: Bencycloquidium Bromide Nasal Spray (Drug)
Mometasone Furoate Aqueous
Mometasone Furoate Aqueous Nasal Spray (50μg per spray)：2 sprays on each nostril, 1 time per day, continuous treatment for 4 weeks (28days).
干预措施: Mometasone Furoate Aqueous Nasal Spray (Drug)
Bencycloquidium Bromide with Mometasone Furoate Aqueous
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.
干预措施: Bencycloquidium Bromide Nasal Spray (Drug)
Bencycloquidium Bromide with Mometasone Furoate Aqueous
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.
干预措施: Mometasone Furoate Aqueous Nasal Spray (Drug)
结局指标
主要结局
Number of adverse events
时间窗: From the start of the enrollment to the end of the study, an average of 35days
adverse clinical events that occur during drug treatment, which may not have a causal relationship with the drug.
Symptom scores of runny nose
时间窗: immediately after the final intervention
It is the symptom scores of runny nose, based on a 4-point method: 0 points: asymptomatic; 1. point: mild symptoms (symptoms are mild and easy to tolerate); 2. points: moderate symptoms (significant symptoms, annoying, but tolerable); 3. points: Severe symptoms (symptoms cannot be tolerated, affecting daily life and/or sleep).
次要结局
- Visual Analogue Scale score of runny nose,nasal congestion, nasal itching, and sneezing(immediately after the final intervention)
- Visual Analogue Scale score of total nasal symptoms(immediately after the final intervention)
- Total Nasal Symptom Scores and Drug score(immediately after the final intervention)
- The questionnaire of patient with global impression of change(immediately after the final intervention)
- The questionnaire of Rhinoconjunctivitis Quality of Life(immediately after the final intervention)