A Comparison of Beclomethasone Aqueous Spray and Aerosol Delivery Systems in Nasal Polyps
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Difference in overall quality of life as measured by the Rhinitis Quality of Life Questionnaire
研究概览
简要总结
The purpose of this study is to determine if intranasal Beclomethasone delivered by aerosol or spray is more effective in treatment of nasal polyps.
详细描述
Aqueous and aerosol delivery of intranasal corticosteroids has never been directly compared previously in patients with nasal polyps and it is unknown whether one is superior.
This objective of this study is to compare the efficacy of intranasal beclomethasone by two different delivery systems, aerosol and aqueous spray in patients with nasal polyps. Primary endpoint is the difference in the overall quality of life as measured by the Rhinitis Quality of Life Questionnaire. The secondary endpoint is the change in Nasal Airflow Resistance as measured by rhinomanometry.
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
- Single (Investigator)
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
- •18 years old
- •New diagnosis of nasal polyps confirmed by two physicians
排除标准
- •Intranasal corticosteroid use within 4 weeks
- •Oral corticosteroids use within 4 weeks
- •Oral corticosteroid inhalation (ie for treatment of asthma or COPD) of Budesonide >400ug daily, Fluticasone >250ug daily, Beclomethasone >400ug daily
- •Contraindication to intranasal corticosteroid
- •Inability to give informed consent
- •Participation in another clinical trial
- •Pregnancy (or not using effective method of contraception) or lactation
- •Cystic fibrosis
研究组 & 干预措施
Aerosol
干预措施: Intranasal Beclomethasone aerosol (Drug)
Spray
干预措施: Intranasal Beclomethasone spray (Drug)
结局指标
主要结局
Difference in overall quality of life as measured by the Rhinitis Quality of Life Questionnaire
时间窗: 0, 1, 3, 6 months
次要结局
- Difference in Nasal Airflow Resistance as measured an anterior rhinomanometry(0, 1, 3, 6 months)