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

NCT ID: NCT05038202

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-16
• Study Completion Date: 2024-06-30

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.

Conditions

Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bencycloquidium Bromide

Bencycloquidium Bromide Nasal Spray (90μg per spray)：1 spray on each nostril, 4times per day, continuous treatment for 4 weeks (28days).

Group Type: EXPERIMENTAL

Bencycloquidium Bromide Nasal Spray

Intervention Type: 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.

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).

Group Type: ACTIVE_COMPARATOR

Mometasone Furoate Aqueous Nasal Spray

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Bencycloquidium Bromide Nasal Spray

Intervention Type: 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.

Mometasone Furoate Aqueous Nasal Spray

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

BILITING; NASONEX

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yingu Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luo Zhang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Beijing Tongren Hospital,CMU

Locations

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

Countries

China

Other Identifiers

YG-BLT-PMS001

Identifier Type: -

Identifier Source: org_study_id