NCT01430260已完成4 期
A Multi-center, Open, Randomized, Three-arm, Parallel-group, Phase IV Study to Compare the Efficacy of Ciclesonide Nasal Spray and Levocetirizine, Alone and in Combination for the Patient With Allergic Rhinitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Handok Inc.
- 入组人数
- 349
- 试验地点
- 1
- 主要终点
- rTNSS
研究概览
简要总结
This i a comparison of the efficacy ciclesonide nasal spray and levocetirizine, alone and in combination.
详细描述
randomized, open-label, three arm, parallel group, multi-center study
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Allergic rhinitis patients aged ≥ 18 years (with a history of AR of 1 years or longer)
- •Moderate to severe patient according to ARIA guideline
- •To have a demonstrated positive skin prick test or other serologic tests to at least 1 allergen.
- •Subjects who complete the subject diary(S) at least 70%.
排除标准
- •Nasal pathology, including nasal polyps, clinically relevant respiratory tract malformations, recent nasal biopsy (within 60 days), nasal trauma, nasal surgery, atrophic rhinitis, rhinitis medicamentosa (within 60 days), asthma requiring corticosteroid treatment
- •Hypersensitivity to corticosteroid and/or hydroxyzine
- •Hypersensitivity to galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption
- •A history of respiratory tract infection or disorder within 2 weeks of the screening visit or had a respiratory tract infection during baseline
- •Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of β-agonists
- •Treated with systemic corticosteroids (within 8 weeks of study initiation) or topical corticosteroids (> 1% hydrocortisone, within 4 weeks of study initiation) or antibiotics (within 2 weeks of first visit)
研究组 & 干预措施
ciclesonide nasal spray
Experimental
ciclesonide nasal spray, alone
干预措施: Ciclesonide (Drug)
Levocetirizine
Active Comparator
Levocetirizine, alone
干预措施: Levocetirizine (Drug)
Ciclesonide nasal spray & Levocetirizine
Active Comparator
Ciclesonide nasal spray & Levocetirizine in combination
干预措施: Ciclesonide & Levocetirizine (Drug)
结局指标
主要结局
rTNSS
时间窗: 2 weeks
change from baseline in the average of AM and PM patient assessed reflective TNSS
次要结局
- rTOSS(2 weeks)
- TNSS(2 weeks)
- PANS(2 weeks)
- RQLQ(2 weeks)
研究者
研究点 (1)
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