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

Primary Purpose

Allergic Rhinitis

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Bencycloquidium Bromide Nasal Spray
Mometasone Furoate Aqueous Nasal Spray
Sponsored by
Yingu Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring allergic rhinitis, Bencycloquidium Bromide Nasal Spray

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing friendship hospital, CMU
  • Beijing Shijitan Hospital,CMURecruiting
  • Beijing Tongren Hospital,CMU
  • The third affliation hospital of Sun YAT-SEN university
  • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
  • Jiangsu Province hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Bencycloquidium Bromide

Mometasone Furoate Aqueous

Bencycloquidium Bromide with Mometasone Furoate Aqueous

Arm Description

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

Mometasone Furoate Aqueous Nasal Spray (50μg per spray)：2 sprays on each nostril, 1 time per day, continuous treatment for 4 weeks (28days).

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.

Outcomes

Primary Outcome Measures

Number of adverse events
adverse clinical events that occur during drug treatment, which may not have a causal relationship with the drug.
Visual Analysis Scale score of runny nose
Visual Analysis Scale (VAS, Visual Analysis Scale) score, from 0 to 10 points, the total symptoms of runny nose 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.

Secondary Outcome Measures

Visual Analogue Scale score of 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
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
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).
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.
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

Full Information

First Posted
August 23, 2021
Last Updated
August 30, 2021
Sponsor
Yingu Pharmaceutical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05038202
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 16, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
February 28, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yingu Pharmaceutical Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
Keywords
allergic rhinitis, Bencycloquidium Bromide Nasal Spray

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
450 subjects with moderate-severe persistent allergic rhinitis will be enrolled in the trial and divided into three groups for different treatment.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bencycloquidium Bromide
Arm Type
Experimental
Arm Description
Bencycloquidium Bromide Nasal Spray (90μg per spray)：1 spray on each nostril, 4times per day, continuous treatment for 4 weeks (28days).
Arm Title
Mometasone Furoate Aqueous
Arm Type
Active Comparator
Arm Description
Mometasone Furoate Aqueous Nasal Spray (50μg per spray)：2 sprays on each nostril, 1 time per day, continuous treatment for 4 weeks (28days).
Arm Title
Bencycloquidium Bromide with Mometasone Furoate Aqueous
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bencycloquidium Bromide Nasal Spray
Other Intervention Name(s)
BILITING
Intervention Description
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
Intervention Name(s)
Mometasone Furoate Aqueous Nasal Spray
Other Intervention Name(s)
NASONEX
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of adverse events
Description
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
Title
Visual Analysis Scale score of runny nose
Description
Visual Analysis Scale (VAS, Visual Analysis Scale) score, from 0 to 10 points, the total symptoms of runny nose 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.
Time Frame
Every day from the start of treatment to the end, an average of 28days
Secondary Outcome Measure Information:
Title
Visual Analogue Scale score of nasal congestion, nasal itching, and sneezing
Description
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
Time Frame
Every day from the start of treatment to the end, an average of 28days
Title
Visual Analogue Scale score of total nasal symptoms
Description
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
Time Frame
Every day from the start of treatment to the end, an average of 28days
Title
Total Nasal Symptom Scores and Drug score
Description
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).
Time Frame
Every day from the start of treatment to the end, an average of 28days
Title
The questionnaire of patient with global impression of change
Description
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.
Time Frame
immediately after the final intervention
Title
The questionnaire of Rhinoconjunctivitis Quality of Life
Description
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
Time Frame
immediately after the final intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luo Zhang, Doctor
Phone
13910830399
Email
dr.luozhang@139.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luo Zhang, Doctor
Organizational Affiliation
Beijing Tongren Hospital,CMU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing friendship hospital, CMU
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hao Tian, Master
Phone
13811161182
Email
tianhao0382@163.com
Facility Name
Beijing Shijitan Hospital,CMU
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xueyan Wang, Master
Phone
15301378519
Email
Wangxueyan20182@163.com
Facility Name
Beijing Tongren Hospital,CMU
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luo Zhang
Phone
13910830399
Email
dr.luozhang@139.com
Facility Name
The third affliation hospital of Sun YAT-SEN university
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qintai Yang, Doctor
Phone
13724859848
Email
yang.qt@163.com
Facility Name
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianjun Chen, Doctor
Phone
13659851719
Email
Ylly80331@163.com
Facility Name
Jiangsu Province hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Cheng, Doctor
Phone
13776620807
Email
chenglei@jsph.org.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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