Volumetric Versus Standard Two Minute Tidal Breathing Methodology for Methacholine Challenge Testing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Methacholine PD20 values of two nebulizers, each with a different testing protocol
研究概览
简要总结
The study will compare a novel volumetric method (performed with the Aerogen Solo vibrating mesh nebulizer) with the standard two-minute tidal breathing protocol (performed with the Wright jet nebulizer) for methacholine challenge testing. The results will then give an indication as to whether the novel technique accurately assesses a given dose of methacholine with the new Aerogen Solo device. In addition, the reproducibility of test results with each method will be examined. Altogether, the findings from this investigation may provide means for better standardization of current testing guidelines.
详细描述
Fifteen asthmatics will be recruited and tested at the University of Saskatchewan for this randomized, two-way crossover study. Two testing methodologies will be performed, the volumetric method with the Aerogen Solo nebulizer and the two-minute tidal breathing method with the Wright nebulizer.
Participants will undergo four methacholine challenges plus a screening methacholine challenge. However, screening is omitted with participants who have completed a methacholine challenge in the last six months. Of the four study challenges, two will utilize the Wright nebulizer with the two-minute tidal breathing method outlined in the 1999 American Thoracic Society Guidelines for Methacholine Challenge Testing. The remaining two challenges will utilize the Aerogen Solo nebulizer with the volumetric method. The timing of the spirometric manoeuvers and the duration of each inhalation cycle will be consistent with both testing methods. Each challenge will be stopped when the participant's forced expiratory volume in 1 second (FEV1) drops by at least 20%. This allows determination of aPC20 (provocative concentration of methacholine causing a 20% fall in FEV1), which will be converted to aPD20 (provocative dose). A minimum 24-hour washout period between challenges will be used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18 or older
- •Stable asthma
- •Baseline methacholine PC20 less than or equal to 16mg/mL
- •Baseline lung function equal or greater than 65% of predicted FEV1
排除标准
- •Use of long-acting bronchodilators within 7 days of visit 1
- •Pregnant or nursing women
- •Cardiovascular problems
- •Upper respiratory tract infection within 4 weeks of visit 1
- •Allergy-induced asthma exacerbation within 4 weeks of visit 1
研究组 & 干预措施
Aerogen Solo
Volumetric method of methacholine challenge testing performed using the Aerogen Solo nebulizer
干预措施: Aerogen Solo Nebulizer (Device)
Wright
Two-minute tidal breathing method of methacholine challenge testing performed using the Wright nebulizer
干预措施: Wright Nebulizer (Device)
结局指标
主要结局
Methacholine PD20 values of two nebulizers, each with a different testing protocol
时间窗: 2 weeks
Do the nebulizers produce similar responses at the same dose
次要结局
- Comparability of PD20 values with a single nebulizer over two methacholine challenges(2 weeks)
研究者
Don Cockcroft
MD, Professor
University of Saskatchewan
