Comparison of the Methacholine PC20 Between the Trudell Aeroeclipse* II Ban Nebulizer and the Wright Nebulizer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Methacholine PC20 of two different aerosol systems
研究概览
简要总结
This study will compare the methacholine PC20 of two different modern-delivery aerosol systems to determine if one may replace the other for use in clinical settings.
详细描述
Thirty three asthmatic subjects (>18 years, both sexes) who have stable asthma will be recruited to undergo methacholine challenges for a randomized, crossover, observational study. The objective of this study is to compare the methacholine PC20 of a modern delivery aerosol system, the Trudell AeroEclipse*II BAN nebulizer, to that of the current "gold standard", the English-Wright nebulizer. Subjects will inhale methacholine using both nebulizing systems on separate visits and the PC20 values will be compared. The results from these experiments will give us a better indication of whether the modern AeroEclipse* II BAN nebulizer might be sufficient to replace the current "gold standard" Wright nebulizer in clinical settings.
Baseline Spirometry
Baseline FEV1 and VC will be registered using an electronic spirometer meeting ATS requirements.
Screening
A medical history will be conducted by interview and asthma medications will be reviewed on this V1. Subjects will also undergo a Methacholine Challenge to determine their PC20 and therefore their eligibility into the study.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with stable asthma.
- •Tidal breathing PC20≤16 mg/mL.
- •Baseline FEV1 more than 65% of predicted normal.
- •Able to complete 3 methacholine challenges on 3 separate days at the same time of day, at least 24-hours apart and within a 2-week period. (1 during screening and the other 2 during the study)
排除标准
- •Airway infection or allergen exposure during the last 4 weeks.
- •Exacerbation during the last 4 weeks.
- •Change in dosage of inhaled or oral steroids during the last 4 weeks.
- •Inhaled salbutamol less than 8 hours prior to testing.
- •Inhaled formoterol or salmeterol less than 36 hours prior to testing.
- •Antihistamines during the last 48 hours.
- •Chronic health conditions that are determined by the principal investigator to be significant (eg cystic fibrosis).
- •Pregnant women.
研究组 & 干预措施
'The English-Wright nebulizer'
The English-Wright nebulizer will be used to perform a methacholine challenge.
干预措施: Methacholine Chloride (Drug)
'The English-Wright nebulizer'
The English-Wright nebulizer will be used to perform a methacholine challenge.
干预措施: The English-Wright nebulizer (Device)
Trudell AeroEclipse*II BAN nebulizer
The Trudell AeroEclipse*II BAN nebulizer will be used to perform a methacholine challenge
干预措施: Methacholine Chloride (Drug)
Trudell AeroEclipse*II BAN nebulizer
The Trudell AeroEclipse*II BAN nebulizer will be used to perform a methacholine challenge
干预措施: Trudell AeroEclipse*II BAN nebulizer (Device)
结局指标
主要结局
Methacholine PC20 of two different aerosol systems
时间窗: 2 weeks
To compare the methacholine PC20 of a modern delivery aerosol system, the Trudell AeroEclipse\*II BAN nebulizer, to that of the current "gold standard", the English-Wright nebulizer. FEV1 is measured by spirometry following inhalation of increasing concentrations of methacholine. The PC20 is a calculated value of the amount of methacholine required to cause a 20% fall in the subject's FEV1.
次要结局
未报告次要终点
研究者
Gail Gauvreau
Investigator
McMaster University