NCT00660829已完成3 期
Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 in Subjects With Seasonal Allergic Rhinitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 536
- 试验地点
- 6
- 主要终点
- Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (TNSS) (AM and PM Combined)at 14 Days
研究概览
简要总结
The Purpose of this study is to determine if one allergy medication (0.15% azelastine hydrochloride) is more effective than Placebo 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
- 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 with a 2 year history of moderate to severe seasonal allergic rhinitis.
- •Must be in generally good health
- •Must meet minimum symptom requirements, as specified in the protocol
- •Must be willing and able to provide informed consent and to participate in all study procedures
- •Positive skin test to a prevalent Texas Mountain Cedar allergen
排除标准
- •On Focused Nasal Examination, the presence of any nasal mucosal erosion, nasal ulceration, or nasal septal perforation at either the screening visit or randomization visit will disqualify the subject from the study.
- •Other nasal disease(s) likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, clinically significant polyposis, or nasal structural abnormalities.
- •Nasal surgery or sinus surgery within the previous year.
- •Chronic sinusitis - more than 3 episodes per year
- •Planned travel outside of the study area during the study period
- •The use of any investigational drug within 30 days prior to Screening. No investigational products are permitted for use during the conduct of this study
- •Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose (Splenda® brand sweetener)
- •Women who are pregnant or nursing
- •Women of childbearing potential who are not abstinent or not practicing a medically acceptable method of contraception
- •Respiratory Tract Infections within 14 days prior to screening
- •Respiratory Tract Infections requiring antibiotic treatment 14 days prior to screening
- •Asthma (with the exception of mild, intermittent asthma). Subjects with mild, intermittent asthma who only require short-acting inhaled bronchodilators (not more often than twice per week) and who do not have nocturnal awakening as a result of asthma are eligible for enrollment
- •Significant pulmonary disease including COPD
- •Clinically significant arrhythmia or symptomatic cardiac conditions
- •A known history of alcohol or drug abuse within the last 2 years
- •Existence of any surgical or medical condition or physical or laboratory findings, which in the opinion of the investigator or sponsor's medical monitor, might significantly alter the absorption, distribution, metabolism, or excretion of study drug; that might significantly affect the subject's ability to complete this trial; or their safety in this trial.
- •Clinically relevant abnormal physical findings which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures
研究组 & 干预措施
1
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
2
Active Comparator
0.15% Azelastine Hydrochloride
干预措施: 0.15% Azelastine Hydrochloride (Drug)
结局指标
主要结局
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (TNSS) (AM and PM Combined)at 14 Days
时间窗: baseline and 14 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 Means Square 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 baseline as co-variate
次要结局
- Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score (SSCS) for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)(baseline and 14-days)
- Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)(baseline and 14 Days)
- Change From Baseline on Direct Visual Nasal Exams at 14 Days(baseline and 14 Days)
- Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (AM) for the Entire 14-day Study Period Compared to Placebo.(baseline and 14 days)
- Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (AM and PM Combined) at 14 Days(baseline and 14-days)
研究者
研究点 (6)
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