NCT01372865已完成3 期
A Phase III, Non-inferiority, Open-label, Multicenter and Randomized Clinical Trial About the Treatment of Mild to Moderate Persistent Allergic Rhinitis With Eurofarma Mometasone or Reference Mometasone.
Eurofarma Laboratorios S.A.1 个研究点 分布在 1 个国家目标入组 364 人开始时间: 2012年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 364
- 试验地点
- 1
- 主要终点
- Nasal Index Score (NIS) scale that evaluates nasal obstruction, coryza, and sneezing
研究概览
简要总结
The primary objective will be to compare the impact of the study formulations on alergic rhinitis carriers.
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
- •Sign and date the informed consent form or, in case of subjects younger than 18 years, the document must also be signed by a legal guardian;
- •≥ 12 years old;
- •Suffer from mild to moderated persistent alergic rhinitis;
- •Total NIS scale score ≥ 4 points at the screening visit and within at least 4 of the 7 days before the randomization visit;
- •Indication for use nasal corticosteroid;
- •Present with alergic rhinitis symptoms for at least 2 years;
- •May undergo a washout period of at least 2 weeks
排除标准
- •Patients with severe alergic rhinitis;
- •Patients with severe co-morbidities (at the investigator's criteria);
- •Patients with mild to severe persistent asthma;
- •Clinical history of infection of the airways 30 days before the study entry;
- •Patients with structural changes causing nasal obstruction, such as pronounced nasal septum deviation, nasal polyps or any other type of nasal malformation;
- •For female subjects, be pregnant or breastfeeding or planning to become pregnant or unwilling to use safe birth control methods during the study;
- •subjects in need of other drugs to treat alergic rhinitis, such as anti-immunoglobulin E, immunotherapy, anti-leukotrienes, oral corticosteroids, inhalant corticosteroids, or any administration route other than cutaneous;
- •Active smokers (use of cigarette, pipe, cigar or any other form of tobacco in any amount within the past 3 months before the study entry);
- •Participation in another clinical study within the past 12 months;
研究组 & 干预措施
Mometasone
Experimental
干预措施: Mometasone furoate (Drug)
Nasonex®
Active Comparator
干预措施: Mometasone furoate (Drug)
结局指标
主要结局
Nasal Index Score (NIS) scale that evaluates nasal obstruction, coryza, and sneezing
时间窗: 04 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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