Clinical trial NCT05038202: Study of Bencycloquidium Bromide Nasal Spray in the Treatment of Moderate-severe Persistent Allergic Rhinitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Allergic Rhinitis
Keywords: allergic rhinitis
Bencycloquidium Bromide Nasal Spray
Lead sponsor: Yingu Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-09-08
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 450 subjects with moderate-severe persistent allergic rhinitis will be enrolled in the trial and divided into three groups for different treatment.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of adverse events
timeFrame: From the start of the enrollment to the end of the study, an average of 35days
measure: Symptom scores of runny nose
timeFrame: immediately after the final intervention
Secondary outcomes:
measure: Visual Analogue Scale score of runny nose,nasal congestion, nasal itching, and sneezing
timeFrame: immediately after the final intervention
measure: Visual Analogue Scale score of total nasal symptoms
timeFrame: immediately after the final intervention
measure: Total Nasal Symptom Scores and Drug score
timeFrame: immediately after the final intervention
measure: The questionnaire of patient with global impression of change
timeFrame: immediately after the final intervention
measure: The questionnaire of Rhinoconjunctivitis Quality of Life
timeFrame: immediately after the final intervention
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing friendship hospital, CMU
state: Beijing
city: Beijing
country: China
facility: Beijing Shijitan Hospital,CMU
state: Beijing
city: Beijing
country: China
facility: Beijing Tongren Hospital,CMU
state: Beijing
city: Guangzhou
country: China
facility: The third affliation hospital of Sun YAT-SEN university
state: Guangdong
city: Wuhan
country: China
facility: Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Nanjing
country: China
facility: Jiangsu Province hospital
state: Jiangsu
Study officials:
affiliation: Beijing Tongren Hospital,CMU
name: Luo Zhang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: