Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 and MP03-33 in Patients With Perennial Allergic Rhinitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 581
- 试验地点
- 42
- 主要终点
- Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days.
研究概览
简要总结
The purpose of this study is to determine if two allergy medications are more effective than placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 of age and older
- •Must be in generally good health
- •Must meet minimum symptom requirements, as specified in protocol
- •Must be willing and able to provide informed consent and participate in all study procedures
- •2-year history of PAR
- •Positive skin test to cockroach, dust mite, mold or cat/dog dander
排除标准
- •On nasal examination, presence of any nasal mucosal erosion, nasal ulceration or nasal septal perforation at the screening or randomization visit
- •Nasal diseases likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, significant polyposis or nasal structural abnormalities
- •Nasal surgery or sinus surgery within the previous year
- •The use of any investigational drug within 30 days
- •Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose
- •Women who are pregnant or nursing
- •Women of child-bearing potential who are not abstinent and not practicing a medically acceptable method of contraception
- •Respiratory tract infection within 2 weeks of screening
- •Respiratory tract infections requiring oral antibiotic treatment within 2 weeks of screening
- •Patients with asthma with the exception of mild, intermittent
- •Significant pulmonary disease including COPD
- •Patients with arrhythmia
- •Patients with a known history of alcohol or drug abuse
- •Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor may significantly alter the absorption, distribution, metabolism or excretion of study drug.
- •Clinically relevant abnormal physical findings within one week of randomization
- •Overnight abscences from home for more than 3 nights
- •Employees of the research center or private practice and family members are excluded
- •Patients who received prohibited medications within specified timepoints in protocol.
研究组 & 干预措施
1
Placebo
干预措施: Placebo (Drug)
2
0.15% azelastine hydrochloride 1644 mcg/2 sprays per nostril 2 times a day for 4 weeks
干预措施: 0.15% azelastine hydrochloride (Drug)
3
0.1% azelastine hydrochloride 1096 mcg/2 sprays per nostril 2 times a day for 4 weeks
干预措施: 0.1% azelastine hydrochloride (Drug)
结局指标
主要结局
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days.
时间窗: baseline and 28 days
Reflective total nasal symptom score consisting of Runny nose, itchy nose, nasal Congestion, and Sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day Least square means (LS Mean) was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate.
次要结局
- Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 Days(baseline and 28 days)
- Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score Compared to Placebo (AM and PM Combined)and 28 Days(baseline and 28 days)
- Change From Baseline in Rinoconjunctivitis Quality of Life Questionnaire and 28 Days(baseline and 28 Days)
- Change From Baseline on Direct Visual Nasal Exams and 28 Days(baseline and 28 days)