Study of Bencycloquidium Bromide Nasal Spray in the Treatment of Moderate-severe Persistent Allergic Rhinitis

Yingu Pharmaceutical Co., Ltd450 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

450

Conditions

Allergic Rhinitis

Interventions

Mometasone Furoate Aqueous Nasal SprayDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (6)

Beijing friendship hospital, CMU

Beijing, Beijing Municipality, China

Beijing Shijitan Hospital,CMU

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

Outcomes

Primary Outcomes

Number of adverse events

adverse clinical events that occur during drug treatment, which may not have a causal relationship with the drug.

Time frame: 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; 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).