Study of Bencycloquidium Bromide Nasal Spray in the Treatment of Moderate-severe Persistent Aller… (NCT05038202) | Clinical Trial Compass
UnknownPhase 4
Study of Bencycloquidium Bromide Nasal Spray in the Treatment of Moderate-severe Persistent Allergic Rhinitis
China450 participantsStarted 2021-06-16
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 pregna…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of adverse events
Timeframe: From the start of the enrollment to the end of the study, an average of 35days
2
Symptom scores of runny nose
Timeframe: immediately after the final intervention