The Efficacy of Nebulized Procaterol Versus Nebulized Salbutamol for the Treatment of Moderate Acute Asthma: a Randomized, Double-blind, Parallel Group Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Difference 5% from baseline in peak expiratory flow rate (PEFR)
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of nebule procaterol with nebule salbutamol in the treatment of moderate acute asthma.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with moderate acute asthma according to Global Initiative for Asthma (GINA) 1998 (Appendix 1). Patients with moderate acute asthma according to Modified Global Initiative for Asthma (GINA) 1998 (Patients with asthma score 5 - 11; PEFR ≤ 80% predicted)
- •Patients of both gender aged 15 to 60 years
- •Patients still have the ability to undergo examinations and give written informed consent
排除标准
- •Pregnant and lactating women
- •Patients with heart disease, hyperthyroidism, diabetes mellitus, COPD or other chronic diseases
- •Patients with signs of severe infections
研究组 & 干预措施
Procaterol
Procaterol inhalation solution 50 micro g per 0.5 mL diluted in 2mL of NaCl 0.9%, so that the volume of the inhalation solution will be similar to that of the comparator drug. The nebule solution will be administered 3 times, i.e. at times 0, 20 and 40 minutes.
干预措施: Procaterol, Salbultamol (Drug)
Salbultamol
Salbultamol inhalation solution for nebulization containing 2.5 mg in 2.5 mL aqueous solution. The nebule solution will be administered 3 times, i.e. at times 0, 20 and 40 minutes.
干预措施: Procaterol, Salbultamol (Drug)
结局指标
主要结局
Difference 5% from baseline in peak expiratory flow rate (PEFR)
时间窗: 3 times every 20 minutes (at 0, 20 and 40 minutes)
次要结局
- Difference 5% from baseline in asthma score(3 times every 20 minutes (at 0, 20 and 40 minutes))