Measurements of Change of Respiratory Admittance Induced by Salbutamol for Pediatric Asthma Diagnosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 177
- 试验地点
- 1
- 主要终点
- Thoracic gas volume
研究概览
简要总结
The purpose is to characterize the change of respiratory admittance induced by salbutamol inhalation in children and young adults. A variation threshold will be fixed to distinguish asthmatic and healthy subjects.
This project could allow a better identification of asthmatic individuals needing a treatment, a reduction of morbidity of asthma, a reduction of unnecessary treatments administered in individuals with respiratory but not asthmatic symptoms, a better comprehension of bronchial hyperreactivity and its role in asthmatic disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Asthmatic children group:
- •Several episodes of paroxysmal wheezes, spontaneous or after exercise, without bronchial-pulmonary infection
- •Absence of bronchodilator taking during last 12 hours
- •Absence of reported intolerance to adrenergic substances
- •Parental authorization and consent of child to participate to the study
- •Control children group:
- •Parental authorization and consent of child to participate to the study
- •Control adult group:
- •Consent to participate to the study
排除标准
- •Control children and adult groups:
- •At least 2 episodes of wheezes during breathing
- •Several wheezes, abnormal breathlessness, cough during physical exercise
- •Asthma diagnosed by family doctor
- •Administration of drugs to treat asthma
- •Eczema or food allergy at inclusion
- •Episode of cough for longer than 6 weeks, without bronchial infection
- •Bronchitis, throat infection, rhino-pharyngitis during last 15 days
- •Paleness or cyanosis with loss of consciousness when the child was a baby or during an exercise
研究组 & 干预措施
Asthma child
干预措施: Salbutamol (Drug)
Asthma child
干预措施: Forced oscillation technique (Procedure)
Asthma child
干预措施: Plethysmography (Procedure)
Control adult
干预措施: Salbutamol (Drug)
Control adult
干预措施: Forced oscillation technique (Procedure)
Control adult
干预措施: Plethysmography (Procedure)
Control child
干预措施: Salbutamol (Drug)
Control child
干预措施: Forced oscillation technique (Procedure)
Control child
干预措施: Plethysmography (Procedure)
结局指标
主要结局
Thoracic gas volume
时间窗: day 0
Measured with Plethysmography.
Ventilatory mechanical impedance
时间窗: day 0
Measured with Forced oscillation technique. 2 measures at basal status at 10 min interval for reproducibility and after 10 min broncodilation with salbutamol
次要结局
未报告次要终点