NCT01470053已完成3 期
A Multicenter, Randomized, Double-blind Phase Ⅲ Study of Mometasone Furoate/Azelastine Hydrochloride Combination Group and Mometasone Furoate and Azelastine Hydrochloride Group 4 Weeks After Treatment, Each Treatment Group Comparisons for Evaluation of Efficacy and Safety in Perennial Allergic Rhinitis Patient.
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
- 347
- 试验地点
- 1
- 主要终点
- change from baseline in rTNSS(reflective Total Nasal Symptom Score)
研究概览
简要总结
The purpose of this study is to evaluate of efficacy and safety of mometasone furoate plus azelastine HCl in patients with perennial allergic rhinitis.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Patients over 12 years of age
- •Medical history of perennial allergic rhinitis for at least two years
- •Moderate ro severe nasal symptom (during placebo run-in period AM rTNSS or PM rTNSS≥8)
- •Positive skin prick test result within the previous 12 months
排除标准
- •patients with active asthma that required therapy with inhaled or oral corticosteroids or long-term β-agonist
- •patients with severe rhinostenosis, severely deviated nasal septum or local infection on the nasal mucous membrane
- •patients with herpes zoster, glaucoma or cataract
- •patients with history of operation or damage on nasal cavity or ocular region
- •patients with drug-induced rhinitis
- •patients with history of respiratory infection which requires antibiotic therapy within the previous 14 days
- •Patients with lung disease including COPD
- •Patients with history of immunotherapy or ongoing immunotherapy
- •patients administered with super potent or potent corticosteroid
- •patients administered with intra-muscular or intra-articular steroid within the previous 3 months
- •patients administered with subcutaneous omalizumab within the previous 5 months
研究组 & 干预措施
mometasone furoate + azelastin HCl
Experimental
opaque suspension, four times each naris per day
干预措施: mometasone furoate plus azelastine HCl (Drug)
mometasone furoate
Active Comparator
opaque suspension, four times each naris per day
干预措施: mometasone furoate (Drug)
azelastine HCl
Active Comparator
lucidus colorless liquid, two times each naris per day
干预措施: azelastine HCl (Drug)
结局指标
主要结局
change from baseline in rTNSS(reflective Total Nasal Symptom Score)
时间窗: 4 weeks
次要结局
- change from baseline in AM rTNSS(AM reflective Total Nasal Symptom Score)(4 weeks)
- change from baseline in PM rTNSS(PM reflective Total Nasal Symptom Score)(4 weeks)
- change from baseline in iTNSS(instantaneous Total Nasal Symptom Score)(4 weeks)
- change from baseline in AM iTNSS(AM instantaneous Total Nasal Symptom Score)(4 weeks)
- change from baseline in PM iTNSS(PM instantaneous Total Nasal Symptom Score)(4 weeks)
研究者
研究点 (1)
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