NCT01574885终止2 期
Double-blind, Randomized, Placebo Controlled Study Evaluating the Efficacy of Aerosal® in the Treatment of Sub-Obstructive Adenotonsillar Hypertrophy and Related Diseases
Tecno Sun SRL2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2012年2月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Percent change from baseline of adenotonsillar hypertrophy degree equal to or greater than 25%
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of Aerosal® compared to a placebo treatment in the prognosis of sub-obstructive adenotonsillar hypertrophy present for at least six months.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sub-Obstructive Adenotonsillar Hypertrophy lasting from at least six months and associated with sleep disordered breathing (respiratory pauses or sleep-apnea) and/or recurrent sero-mucus otitis
- •Suspension for more than 3 months from the date of any immunosuppressive treatments (cyclosporin, systemic steroids)
排除标准
- •Patients with acute bronchopulmonary disease, tuberculosis, severe hypertension, hyperthyroidism, cancer (chemotherapy), intoxication, heart failure, bronchial asthma.
- •Iodine allergy
结局指标
主要结局
Percent change from baseline of adenotonsillar hypertrophy degree equal to or greater than 25%
时间窗: 2 weeks (10 sessions), 14 weeks
次要结局
- Change from baseline of hypoacusis equal to or greater than 10 dB(2 weeks (10 sessions), 14 weeks)
- Any change from baseline of tympanometry curve(2 weeks (10 sessions), 14 weeks)
- Any change from baseline of adenotonsillar hypertrophy degree(2 weeks (10 sessions), 14 weeks)
- Any change from baseline of basal SpO2% levels(2 weeks (10 sessions), 14 weeks)
- Any change from baseline of apnea index(2 weeks (10 sessions), 14 weeks)
- Any change from baseline of sleep time percentage with SpO2<95%(2 weeks (10 sessions), 14 weeks)
- Any change from baseline of hypoacusis(2 weeks (10 sessions), 14 weeks)
- Number of reported adverse events(2 weeks (10 sessions), 14 weeks)
研究者
研究点 (2)
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