Efficacy of Intermittent Tiotropium in Early Childhood Wheezing
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Percentage of Episode-Free Days
研究概览
简要总结
This study evaluates the effect of intermittent tiotropium bromide and salbutamol as needed versus intermittent fluticasone propionate and salbutamol as needed, or solely, salbutamol as needed on episode-free days in infants and toddlers with recurrent episodes of wheeze and/or shortness of breath.
详细描述
Up to 30% of all children suffer from episodic wheeze or shortness of breath, i.e. asthmatic bronchitis, during the first three years of life. The condition is usually induced by viral respiratory infections, and short-acting beta-agonists are recommended as a monotherapy for symptoms unless there are at least four physician-confirmed episodes of wheeze or shortness of breath, or three episodes plus asthma risk factors. There is a current need for new therapeutic agents to treat asthmatic bronchitis in young children.
In viral-induced wheeze, increased parasympathetic nerve activity results in increased acethylcholine release from nerve endings. Tiotropium bromide, an inhaled anticholinergic agent, prevents the acetylcholine function and achieves mild bronchodilatation and decrease in mucus secretion from the submucosal glands.
The aim of the study is to find out the effect of intermittent tiotropium bromide and salbutamol as needed versus intermittent fluticasone propionate and salbutamol as needed, or solely, salbutamol as needed on episode-free days in infants and toddlers with recurrent episodes of wheeze and/or shortness of breath. Episode-free days are defined as those days during which there are no symptoms of wheeze and/or shortness of breath, no unscheduled medical visits for wheeze and/or shortness of breath, and no use of rescue or supplementary controller medications.
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
- None
入排标准
- 年龄范围
- 6 Months 至 35 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children at the age of 6 to 35 months.
- •Two to four physician-confirmed episodes of wheeze and/or shortness of breath.
- •Parents/legal representatives with sufficient written and spoken skills in Finnish language.
排除标准
- •Birth before 36th week of gestation.
- •Suspected/diagnosed chronic parenchymal lung disease or a structural airway defect, or a history of thoracotomy with pulmonary resection.
- •A history of congenital or acquired heart disease, including any unstable or life-threatening cardiac arrhythmia.
- •Constipation with a need of regular medication, or a diagnosed/suspected structural defect in the gastrointestinal tract.
- •A history of malignancy, or other significant chronic disorder, disease, or defect.
研究组 & 干预措施
Tiotropium Bromide & Salbutamol
Inhaled Tiotropium Bromide 5 µg once a day, beginning at the onset of an upper respiratory tract infection and continuing for 7 to 14 days as needed, and inhaled Salbutamol 0.2 mg 4 to 6 times a day as needed for wheeze and shortness of breath
干预措施: Tiotropium Bromide (Drug)
Tiotropium Bromide & Salbutamol
Inhaled Tiotropium Bromide 5 µg once a day, beginning at the onset of an upper respiratory tract infection and continuing for 7 to 14 days as needed, and inhaled Salbutamol 0.2 mg 4 to 6 times a day as needed for wheeze and shortness of breath
干预措施: Salbutamol (Drug)
Fluticasone Propionate & Salbutamol
Inhaled Fluticasone Propionate 125 µg twice a day, beginning at the onset of an upper respiratory tract infection and continuing for 7 to 14 days as needed, and inhaled Salbutamol 0.2 mg 4 to 6 times a day as needed for wheeze and shortness of breath
干预措施: Fluticasone Propionate (Drug)
Fluticasone Propionate & Salbutamol
Inhaled Fluticasone Propionate 125 µg twice a day, beginning at the onset of an upper respiratory tract infection and continuing for 7 to 14 days as needed, and inhaled Salbutamol 0.2 mg 4 to 6 times a day as needed for wheeze and shortness of breath
干预措施: Salbutamol (Drug)
Salbutamol
Inhaled Salbutamol 0.2 mg 4 to 6 times a day as needed for wheeze and shortness of breath
干预措施: Salbutamol (Drug)
结局指标
主要结局
Percentage of Episode-Free Days
时间窗: Up to 48 weeks
Effect on the episode-free days defined as the days during which there are no symptoms of wheeze and/or shortness of breath, no unscheduled medical visits for wheeze and/or shortness of breath, and no use of rescue or supplementary controller medications.
次要结局
- Number of Participants With Unscheduled Physician Visits(Up to 48 weeks)
- Percentage of Days Participants Needed Rescue Medication(Up to 48 weeks)
- Number of Participants With Adverse Events(Up to 48 weeks)
研究者
Anne Kotaniemi-Syrjänen
MD, PhD
Helsinki University Central Hospital