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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Drug: Bencycloquidium Bromide Nasal Spray; Drug: Mometasone Furoate Aqueous Nasal Spray

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.

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Luo Zhang, Doctor; Phone Number: 13910830399; Email: dr.luozhang@139.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Beijing friendship hospital, CMU
    • Beijing, Beijing, China
      • Beijing Shijitan Hospital,CMU
    • Beijing, Beijing, China
      • Beijing Tongren Hospital,Cmu
  • Guangdong
    • Guangzhou, Guangdong, China
      • The third affliation hospital of Sun YAT-SEN university
  • Hubei
    • Wuhan, Hubei, China
      • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Jiangsu Province Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bencycloquidium Bromide; Bencycloquidium Bromide Nasal Spray (90μg per spray)：1 spray on each nostril, 4times per day, continuous treatment for 4 weeks (28days).	Drug: Bencycloquidium Bromide Nasal Spray; 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.; Other Names: BILITING
Active Comparator: 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).	Drug: Mometasone Furoate Aqueous Nasal Spray; 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.; Other Names: NASONEX
Experimental: 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.	Drug: Bencycloquidium Bromide Nasal Spray; 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.; Other Names: BILITING; Drug: Mometasone Furoate Aqueous Nasal Spray; 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.; Other Names: NASONEX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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; point: mild symptoms (symptoms are mild and easy to tolerate);; points: moderate symptoms (significant symptoms, annoying, but tolerable);; points: Severe symptoms (symptoms cannot be tolerated, affecting daily life and/or sleep).	immediately after the final intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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; point: the symptoms are completely controlled or disappeared;; points: Significant improvement in symptoms;; points: the improvement of symptoms is not obvious;; points: Symptoms are not improved or even worsened.	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
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	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; point: mild symptoms (symptoms are mild and easy to tolerate);; points: moderate symptoms (significant symptoms, annoying, but tolerable);; points: Severe symptoms (symptoms cannot be tolerated, affecting daily life and/or sleep). Drug score: 0 points: No other drugs used to treat Allergic Rhinitis; point: Use oral antihistamines (Loratadine tablets designated in the trial, trade name: Claritin);; points: use nasal hormones (not applicable for this trial);; points: use oral hormones (not applicable for this trial).	immediately after the final intervention

Collaborators and Investigators

• Sponsor: Yingu Pharmaceutical Co., Ltd
• Investigators: Principal Investigator: Luo Zhang, Doctor, Beijing Tongren Hospital,Cmu

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2021
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: August 23, 2021
• First Submitted That Met QC Criteria: August 30, 2021
• First Posted (Actual): September 8, 2021

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: allergic rhinitis; Bencycloquidium Bromide Nasal Spray
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Anti-Inflammatory Agents; Dermatologic Agents; Anticonvulsants; Anti-Allergic Agents; Mometasone Furoate; Bromides
• Other Study ID Numbers: YG-BLT-PMS001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No