Active Controlled Trial of the Safety and Tolerability of MP 03-036 (Astepro 0.15%) in Patients With Perennial Allergic Rhinitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 703
- 试验地点
- 58
- 主要终点
- Change From Baseline on Direct Visual Nasal Exams to 12 Months
研究概览
简要总结
The purpose of this study is to determine if one allergy treatment (0.15% azelastine hydrochloride) is as safe as mometasone furoate (nasonex) alone.
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
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients 12 years and older with a compatible history greater than or equal to 1 year of rhinitis due to perennial allergies.
- •Must be willing and able to provide informed consent and to participate in all study procedures
- •Must be in generally good health
- •Positive skin test to a prevalent perennial allergen
排除标准
- •On nasal examination, the presence of nasal mucosal erosion, nasal ulceration or nasal septal perforation
- •Use of any investigational drug within 30 days of the first visit
- •Any nasal surgery or sinus surgery within the previous year
- •Presence of any hypersensitivity to drugs similar to azelastine or mometasone furoate and to either sorbital or sucralose
- •Women who are pregnant or nursing
- •Women who are not using an acceptable method of birth control
- •Nasal Diseases likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa or clinically significant nasal polyposis or nasal structural abnormalities.
- •Asthma or other lung diseases such as COPD. Mild asthma symptoms may be considered after consultation with investigator.
- •Patients with Arrythmia
- •Patients with know history of alcohol and drug abuse
- •Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor, might significantly alter the evaluation of the study.
- •Use of medications that could affect the study results
研究组 & 干预措施
1
0.15% azelastine hydrochloride 1644 mcg
干预措施: 0.15% azelastine hydrochloride (Drug)
2
Mometasone furoate 200 mcg
干预措施: Mometasone furoate (Drug)
结局指标
主要结局
Change From Baseline on Direct Visual Nasal Exams to 12 Months
时间窗: Change from baseline to 12 months
Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irritation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation
次要结局
未报告次要终点