Use of the AeroEclipse II Breath Actuated Nebulizer for the Delivery of Methacholine Chloride Bronchoprovocation Agent: A Pilot Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Methacholine inhalation challenge
研究概览
简要总结
Traditional, continuous-mode nebulizers such as the English-Wright nebulizer are designed to operate continuously with tidal breathing. As inhalation accounts for only about one-third of the respiratory cycle, two-thirds of the continuously produced aerosol is lost to the environment possibly posing a hazard any fellow-patients, family members, or health-care workers in the vicinity. The English-Wright has been the only American Thoracic Society (ATS)recommended device available on the market. Recently Roxon Medi-Tech has announced the discontinuation of the English-Wright nebulizer. For these reasons it is necessary to review the use of other nebulizers such as the AeroEclipse II breath-actuated nebulizer and further validate their performance.
The investigators expect to show equivalence between the AeroEclipse II and the English-Wright nebulizers.
详细描述
This study would like to determine if the use of the Aeroeclipse II breath actuated nebulizer for the delivery of methacholine chloride bronchoprovocation agent to the lungs results in the same Provocation Concentration PC20 (provocation concentration, or dose that causes a 20% decrease in Forced Expiratory Volume in 1 sec or FEV1) as using the English-Wright nebulizer for the delivery of methacholine chloride bronchoprovocation agent to the lungs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 10 to 65 years at time of recruitment into this study,
- •Diagnosis of current asthma by a health care professional,
- •Tidal breathing Provocation Concentration ≤ 16 mg/mL,
- •Forced Expiratory Volume 1> 65% of predicted,
- •No respiratory tract infection or allergen exposure ≥ 4 weeks,
- •Able to complete 2 methacholine inhalation challenges on 2 separate days at the same time of day, at least 24-h apart, and within a 2-week period,
- •Inhaled salbutamol withheld for ≥8 hours prior to testing,
- •Inhaled corticosteroid maintained at same dose throughout study,
- •inhaled formoterol and salmeterol withheld for ≥36 hours prior to testing.
排除标准
- •Those born prematurely (more than 4 weeks early of the calculated date),
- •Those with chronic health conditions like diabetes or cystic fibrosis,
结局指标
主要结局
Methacholine inhalation challenge
时间窗: Visit 2 (up to 2 weeks)
A methacholine inhalation challenges will be performed at each of the first two visits. At the first clinic visit each subject will be randomly assigned to use either the English-Wright continuous-mode nebulizer, or the AeroEclipse II breath actuated nebulizer. The alternate nebulizer will be used during the second clinic visit. The methacholine concentration producing a 20% decrease in Forced Expiratory Volume in 1 second (PC20) will be measured by way of a standard breathing challenge (the tidal breathing Cockcroft technique)
次要结局
- Methacholine challenge - Cumulative Effect(Week 3 +/- 1 week)
研究者
Sharon Dell
Staff Physician
The Hospital for Sick Children