Efficacy of Azelastine and Mometasone Irrigation in Comparison to Nasal Sprays in Patients With Chronic Rhinitis
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Improvement seen in the Sino-Nasal Outcome Test (SNOT)-22 score
研究概览
简要总结
The goal of this clinical trial is to determine the best combination of drugs and drug delivery routes to treat surgically naive chronic rhinitis patients. The main question it aims to answer is:
Do high volume, high pressure delivery mechanisms in nasal irrigation improve the efficacy of azelastine combined with nasal steroid mometasone as compared to the standard low pressure, low volume delivery mechanisms in nasal sprays?
Subjects will complete six months of one of three medication regimens:
- Saline irrigation followed by azelastine spray and mometasone spray
- Mometasone saline irrigation
- Azelastine saline irrigation combined with mometasone saline irrigation.
详细描述
The purpose of this research is to determine whether patients with chronic rhinitis treated with mometasone and azelastine irrigations will show significant clinical improvement when compared to patients treated with mometasone and azelastine nasal sprays, and also compared to nasal irrigation with mometasone alone. Patients with chronic rhinitis require lifelong treatment options that are safe yet efficacious. Topical therapies, such as antihistamine sprays and steroid sprays as well as saline irrigations, are appropriate options as they offer symptom control without the side effects often seen in antibiotics. Azelastine and mometasone are FDA approved medications for the treatment of chronic rhinitis. Using these drugs in an off-label format in the form of irrigations rather than sprays is standard of care in rhinology. Prior studies suggest irrigation may be better than spray for topical mometasone, but more data is needed to establish the same for the combination of mometasone and azelastine. Eligible patients who are enrolled in the study will be randomized and will complete six months of one of three medication regimens. Subjects will come back to the office for three follow up visits at 4, 12, and 24 weeks after the treatment, where they will have a basic nasal endoscopy performed and be asked to complete a questionnaire about their nasal blockage symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Arm 1 is not blinded because this is the spray group. Arm 2 and 3 are blinded because these are both irrigation groups-either just mometasone or mometasone combined with azelastine
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 18 years and older seeking treatment for chronic rhinitis and willing to undergo six months of topical therapy.
- •Diagnosis of Chronic Rhinitis.
排除标准
- •The patient has diagnosis(es) other than chronic rhinitis that can account for his/her symptoms (septal deviation, nasal valve collapse, chronic sinusitis).
- •Use of oral antihistamines or oral steroids, unless patient undergoes a 4 week washout period.
- •Smokers (tobacco, marijuana, vaping, etc.).
- •Known or suspected pregnancy, or lactation.
- •Other medical conditions that the investigator believed would confound the study.
- •Allergy to study drugs.
研究组 & 干预措施
Azelastine and Mometasone Nasal Spray
The study intervention will be saline irrigation (240 mL) followed by azelastine spray (137 mcg/spray) and mometasone spray (50 mcg/spray). Participants will have to dissolve the salt packet in a 240 mL sinus rinse bottle to create the saline solution. All participants will be instructed to perform the following twice a day: irrigation of right and left nasal cavity with half of the saline solution for each side followed by 2 sprays per nostril of both of the nasal sprays.
干预措施: Azelastine (137 mcg/spray) Nasal Spray and Mometasone (50 mcg/spray) Nasal Spray (Drug)
Mometasone Nasal Irrigation
The study intervention will be mometasone (1 mg/capsule). Participants will be required to dissolve the contents of the capsule into a 240 mL sinus rinse bottle along with the salt packet to create the rinse solution. All participants will be instructed to perform the following twice a day: irrigation of right and left nasal cavity with half of the rinse solution for each side.
干预措施: Mometasone Nasal Irrigation (1 mg capsule) (Drug)
Azelastine and Mometasone Nasal Irrigation
The study intervention will be azelastine (1mg) and mometasone (1 mg). The azelastine and mometasone will be provided in one capsule identical to the mometasone capsule. Participants will be required to dissolve the contents of the capsule into a 240 mL sinus rinse bottle along with the salt packet to create the rinse solution. All participants will be instructed to perform the following twice a day: irrigation of right and left nasal cavity with half of the rinse solution for each side.
干预措施: Mometasone (1 mg) and Azelastine (1 mg) Nasal Irrigation (Drug)
结局指标
主要结局
Improvement seen in the Sino-Nasal Outcome Test (SNOT)-22 score
时间窗: Baseline, 1 month, 3 months, 6 months
Sino-Nasal Outcome Test (SNOT-22) scores will be measured at baseline, 1 month, 3 months, and 6 months. Scores will be compared between three arms. The Sino-Nasal Outcome Test is a self-administered questionnaire that is used to assess nasal symptoms using a 0-5 point scale with 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be. The SNOT-22 consists of 22 questions, rated from 0 to 5 for a minimum score of 0 to maximum score of 110, with higher scores indicating worse symptoms.
次要结局
未报告次要终点
研究者
Auddie Sweis
Principal Investigator
NorthShore University HealthSystem