NCT02235428终止4 期
Double-blind, Controlled Trial to Assess the Efficacy of Ipratropium Bromide Associated With High Dose Salbutamol by Repeated Nebulisation Versus Repeat Nebulisation of Salbutamol Alone, for 120 Minutes, in Acute Asthmatic Attacks in Young Children
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 3
- 主要终点
- Changes from baseline in pulmonary resistance (Rint) between T0 and T120
研究概览
简要总结
To determine whether addition of ipratropium bromide to salbutamol nebulisations produces significantly greater bronchodilation in young children presenting to an emergency department with an acute attack of 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
- Double
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Boys or girls between 3 and 6 years old
- •Presenting to emergency departments with an acute asthmatic attack
- •Requiring nebulised bronchodilator therapy
- •Rint increased by 200 % compared to theoretical Rint
- •Signed, informed consent obtained from the child's parents/legal guardian in accordance with current national legislation and good clinical practice (GCP) defined by the International Conference on Harmonization (ICH)
排除标准
- •Ipratropium bromide received within four hours before admission
- •First acute asthmatic attack
- •Hospital admission to intensive care with asthma within six months before inclusion
- •Hospital admission for asthma during the month prior to inclusion
- •Corticosteroid-dependent asthma (oral corticosteroid therapy) or recently stopped corticosteroid therapy
- •Concomitant cardiac disease
- •Life threatening disease requiring immediate management; including: silent chest on auscultation, cyanosis, bradycardia less than 60 beats/min (bpm), confusion, coma
- •Hypersensitivity to ipratropium bromide, salbutamol, or to any of their excipients
- •Renal or hepatic insufficiency
- •Poorly controlled diabetes
- •Patients suffering from a disease considered to be severe by the investigator and which, in the opinion of the investigator, could interfere or invalidate the measurements performed in the trial
- •Past history of lung surgery
- •Major respiratory disease: pulmonary fibrosis, bronchiectasis, sarcoidosis, tuberculosis, respiratory disease due to AIDS, cystic fibrosis
- •Patients unable to follow with protocol or correctly undergo the evaluations
- •Patients who are taking part in another clinical trial during this trial or who have done so within the month before the trial
- •Previous participation in this trial
研究组 & 干预措施
Ipratropium bromide
Experimental
干预措施: Ipratropium bromide (Drug)
Ipratropium bromide
Experimental
干预措施: Salbutamol (Drug)
Salbutamol
Active Comparator
干预措施: Placebo (Drug)
Salbutamol
Active Comparator
干预措施: Salbutamol (Drug)
结局指标
主要结局
Changes from baseline in pulmonary resistance (Rint) between T0 and T120
时间窗: Baseline, 120 minutes after drug administration
次要结局
- Assessment of wheezing on a 4-point scale(Up to 120 minutes after drug administration)
- Changes in respiratory rate(Up to 120 minutes after drug administration)
- Changes in measurement of pulmonary resistance(Up to 120 minutes after drug administration)
- Number of patients with adverse events(Up to 17 days after last drug administration)
- Assessment of accessory muscle recruitment on a 4-point scale(Up to 120 minutes after drug administration)
- Hospital Admission rate(120 minutes after drug administration)
- Assessment of dyspnoea on a 4-point scale(Up to 120 minutes after drug administration)
- Changes in Oxygen Saturation (ambient air)(Up to 120 minutes after drug administration)
- Number of patients dropped out because of lack of efficacy(Up to 120 minutes after drug administration)
- Number of patients with clinical significant findings in blood pressure(Up to 120 minutes after drug administration)
- Number of patients dropped out because of adverse events(Up to 17 days after last drug administration)
- Number of patients with clinical significant findings in heart rate(Up to 120 minutes after drug administration)
- Assessment of Patient Status by investigator on a 3-question list(72 hours after drug admimistration)
研究者
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