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

Yingu Pharmaceutical

Status and phase: Active, not recruiting; Phase 4

Conditions: Allergic Rhinitis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05038202

YG-BLT-PMS001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

450 participants in 3 patient groups

Bencycloquidium Bromide

Experimental group

Description:

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

Treatment:

Drug: Bencycloquidium Bromide Nasal Spray

Mometasone Furoate Aqueous

Active Comparator group

Description:

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

Treatment:

Drug: Mometasone Furoate Aqueous Nasal Spray

Bencycloquidium Bromide with Mometasone Furoate Aqueous

Experimental group

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.

Treatment:

Drug: Mometasone Furoate Aqueous Nasal Spray

Drug: Bencycloquidium Bromide Nasal Spray