Efficacy and Safety of Loratadine-Betamethasone Oral Solution (1 mg/0.05 mg/1 mL) for Initial Treatment of Severe Perennial Allergic Rhinitis in School Age Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- To evaluate efficacy and safety of loratadine/betamethasone oral solution (1 mg/0.05 mg/1 mL), at a dose of 10 mg/0.5 mg, respectively, as an initial treatment for severe perennial allergic rhinitis in school age children
研究概览
简要总结
This study attempts to document the therapeutic value of combining loratadine antihistamine action (no sedative) with anti-inflammatory effects of betamethasone at low doses, which may facilitate treatment adherence by patients whereas providing an effective and rapid perennial allergic rhinitis (PAR) symptoms relief.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of perennial allergic rhinitis.
- •Age >= 6 years old and <= 12 years old.
- •Patients in good general conditions, without any other relevant clinical condition except for perennial allergic rhinitis.
- •Symptoms total score at admission >= 8 (out of 15 possible). Individual symptoms (score 0 to 3 points) were: Sneezing or nasal pruritus, eye reddening or pruritus, nasal congestion, wet nose or with secretion (sniffing), secretion sensation at pharynx (post-nasal dripping).
- •Number of symptoms: At least three.
排除标准
- •Age < 6 years old or > 12 years old.
- •Co-existence of acute sinusitis or some chronic condition different from asthma or atopic dermatitis.
- •Presence of systemic fungal infections.
- •Conscience or behavioral disturbances.
- •Current oral or parenteral steroid treatment.
- •Concomitant use of Phenobarbital, rifampicin, diphenylhydantoin or ephedrine.
- •Known hypersensitivity to any of the study pharmacological combination components.
研究组 & 干预措施
loratadine/betamethasone oral solution
loratadine/betamethasone oral solution (1 mg/0.05 mg/1 mL), at a dose of 10 mg/0.5 mg
干预措施: Loratadine (Drug)
loratadine/betamethasone oral solution
loratadine/betamethasone oral solution (1 mg/0.05 mg/1 mL), at a dose of 10 mg/0.5 mg
干预措施: Betamethasone (Drug)
结局指标
主要结局
To evaluate efficacy and safety of loratadine/betamethasone oral solution (1 mg/0.05 mg/1 mL), at a dose of 10 mg/0.5 mg, respectively, as an initial treatment for severe perennial allergic rhinitis in school age children
时间窗: Day 6 (Final visit)
次要结局
未报告次要终点