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

• Status: Recruiting
• Trial end date: 2022-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yingu Pharmaceutical Co., Ltd
• Treatments: Bromides; Mometasone Furoate

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.