跳至主要内容
临床试验/NCT02965482
NCT02965482已完成不适用

Volumetric Versus Standard Two Minute Tidal Breathing Methodology for Methacholine Challenge Testing

University of Saskatchewan1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2016年11月1日最近更新:
适应症
干预措施

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

Active Comparator

Volumetric method of methacholine challenge testing performed using the Aerogen Solo nebulizer

干预措施: Aerogen Solo Nebulizer (Device)

Wright

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Don Cockcroft

MD, Professor

University of Saskatchewan

研究点 (1)

Loading locations...

相似试验