Randomized, Double Blind, Double Dummy, Placebo Controlled Trial to Compare the Effectiveness of Formoterol vs Ipatropioum Bromide Plus Fenoterol in Asthmatic Children (5-<12 Years) With Acute Bronchial Obstruction Attending Emergency Services
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Mean Change in Maximum Expiratory Flow From Baseline to Final Evaluation
研究概览
简要总结
To determine efficacy and tolerability of inhaled Formoterol vs nebulized Ipatropioum Bromide plus Fenoterol in cumulative sequential doses in asthmatic children (5-<12 years) with acute bronchial obstruction attending emergency services
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
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Asthmatic children 5-<12 years old, requiring emergency services for acute bronchial obstruction mild to moderate determined by functional and clinical evidence
排除标准
- •Patients with severe acute bronchial obstruction determined by functional and clinical evidence
- •Patients unable to use the inhaling device at time of treatment
- •Patients who received a bronchodilator drug within the last 12 hours
- •Patients who received inhaled steroids within the last 72 hours
- •Patients who received systemic steroids within the last 7 days
- •Patients with near fatal asthma history
- •Patients with fever (>38.5°C axillar temp)
- •Patients with any clinical significance condition
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Formoterol (Foradil®)
Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
干预措施: Formoterol fumerate (Drug)
Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg
Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
干预措施: fenoterol/ipratropium bromide (Drug)
结局指标
主要结局
Mean Change in Maximum Expiratory Flow From Baseline to Final Evaluation
时间窗: Baseline,4 hours
Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by Maximum Expiratory Flow.
Mean Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Final Evaluation
时间窗: Baseline,4 hours
Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by Forced Expiratory Volume in 1 second. FEV1 is defined as the volume of air that can be forced out of the lungs in 1 second after taking a deep breath.
Mean Change in Pulse Oxymetry From Baseline to Final Evaluation
时间窗: Baseline, 4 hours
Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by Pulse Oximetry used to monitor the percentage of oxygen saturation of hemoglobin in the blood.
Mean Change in the Conway Clinical Scale Score From Baseline to Final Evaluation
时间窗: Baseline,4 hours
Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by the Conway Clinical Scale. Assessment of the following: Wheezing, Accessory Muscle Use and Pulse Frequency in a 0 to 3 point scale according to severity for a minimum of 0 points and a total of 9 points in a very severe clinical case.
次要结局
- Safety Assessed by: Pulse Oxymetry, Clinical Assessments, Adverse Events(4 hours)
- Pharmacoeconomic Analysis(4 hours)