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

NCT05038202 | Active Not Recruiting Phase 4

• 1 other identifier: YG-BLT-PMS001
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 6

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.

Conditions

Allergic Rhinitis

Keywords

allergic rhinitis; Bencycloquidium Bromide Nasal Spray

Outcome Measures

Primary Outcomes (2)

• 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; 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).

  immediately after the final intervention

Secondary Outcomes (5)

• 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

Study Arms (3)

Bencycloquidium Bromide

EXPERIMENTAL

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

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).

Drug: Mometasone Furoate Aqueous Nasal Spray

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.

Drug: Bencycloquidium Bromide Nasal Spray; Drug: Mometasone Furoate Aqueous Nasal Spray

Interventions

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.

Also known as: BILITING

Bencycloquidium Bromide; Bencycloquidium Bromide with Mometasone Furoate Aqueous

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.

Also known as: NASONEX

Bencycloquidium Bromide with Mometasone Furoate Aqueous; Mometasone Furoate Aqueous

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yingu Pharmaceutical Co., Ltd: lead

Study Sites (6)

Beijing friendship hospital, CMU

Beijing, Beijing Municipality, China

Location

Beijing Shijitan Hospital,CMU

Beijing, Beijing Municipality, China

Location

Beijing Tongren Hospital,CMU

Beijing, Beijing Municipality, China

Location

The third affliation hospital of Sun YAT-SEN university

Guangzhou, Guangdong, China

Location

Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

Jiangsu Province hospital

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Mometasone Furoate

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Luo Zhang, Doctor

  Beijing Tongren Hospital,CMU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 450 subjects with moderate-severe persistent allergic rhinitis will be enrolled in the trial and divided into three groups for different treatment.

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: September 8, 2021
• Study Start: June 16, 2021
• Primary Completion: April 30, 2024
• Study Completion: June 30, 2024
• Last Updated: March 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)