Combination Therapy With Mometasone Furoate and Oxymetazoline in the Treatment of Adenoid Hypertrophy Concomitant With Allergic Rhinitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 主要终点
- symptom score assessed by TNSS scopring system
研究概览
简要总结
The purpose of this study is to determine the effect of MF/OXY in the treatment of adenoid hypertrophy children with severe allergic rhinitis.
详细描述
The investigators performed a two stages, parallel, randomized, double-blind, double-dummy, clinical trial in 240 AH children concomitant with perennial allergic rhinitis. In the first treatment stage, the 240 children were assigned to MF (50μg, 1 puff in each nostril every evening) or control group (normal saline) after two week's run-in period. After 6 week's treatment, the children in MF group were evaluated and grouped as responders and non-responders according to subjective symptoms and objective performance.
Responders were followed up for six months and reassessed. Non-responders underwent 2-week washout period and were randomly assigned to 4 groups receiving the following treatments: placebo, OXY (0.05%, 1 puff in each nostril every evening) or MF (50μg, 1 puff in each nostril every evening). All participants received 8 weeks' MF or its placebo plus one week's OXY or its placebo for every second week. After that, the patients were followed for six months and the evaluation was done at different time points.
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
- 5 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adenoid occluding at least 75% of the nasopharynx at nasal endoscopy
- •age between 5 and 11 years
- •chronic obstructive nasal symptoms no less than 12 months
- •moderate-to-severe AR
排除标准
- •tonsillar hypertrophy
- •upper respiratory infection within the last 2 weeks
- •sinonasal anatomic anomalies or diseases
- •craniofacial malformations
- •genetic diseases (i.e., Down's syndrome)
- •neurologic or cardiovascular diseases
- •immunodeficiency
- •history of epistaxis
- •hypersensitivity to MF or OXY
- •undergoing intranasal, topical, or systemic steroid or antibiotic treatment within the past 4 weeks
研究组 & 干预措施
mometasone furoate
In the first treatment stage, 120 children were assigned to mometasone furoate (50μg, 1 puff in each nostril every evening) after two week's run-in period.
干预措施: mometasone furoate (Drug)
Placebo
In the first treatment stage, 120 children were assigned to control group (normal saline) after two week's run-in period.
干预措施: Placebo (Drug)
Oxymetazoline + Placebo
Stage two is a parallel, randomized, double-blind, double-dummy study. Non-responders underwent 2-week washout period and were randomly assigned to groups receiving Oxymetazoline and placebo.
干预措施: Oxymetazoline + Placebo (Drug)
Placebo + placebo
Stage two is a parallel, randomized, double-blind, double-dummy study. Non-responders underwent 2-week washout period and were randomly assigned to groups receiving placebo and placebo.
干预措施: Placebo + placebo (Drug)
mometasone furoate + Placebo
Stage two is a parallel, randomized, double-blind, double-dummy study. Non-responders underwent 2-week washout period and were randomly assigned to groups receiving mometasone furoate and placebo.
干预措施: mometasone furoate + Placebo (Drug)
mometasone furoate + Oxymetazoline
Stage two is a parallel, randomized, double-blind, double-dummy study. Non-responders underwent 2-week washout period and were randomly assigned to groups receiving mometasone furoate and Oxymetazoline.
干预措施: mometasone furoate + Oxymetazoline (Drug)
结局指标
主要结局
symptom score assessed by TNSS scopring system
时间窗: six months
次要结局
- nasal volume assessd by Acoustic rhinometry(six months)
- adenoid size assessed by nasopharyngoscope （calculated the adenoid area in relation to the nasopharyngeal area）(six months)
研究者
Wenlong Liu
Research secretary
Guangzhou Women and Children's Medical Center