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临床试验/NCT02822859
NCT02822859已完成不适用

A Comparison of Three Nebulizers for Standard Clinical and Research Use in Methacholine Challenge Testing

University of Saskatchewan6 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年6月最近更新:
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
60
试验地点
6
主要终点
airway responsiveness to methacholine (methacholine pd20)

研究概览

简要总结

The study will assess three different nebulizers for use in methacholine challenge testing in order to determine if the Aeroneb Solo would make a suitable replacement for the long-used and now obsolete Wright and Bennett-Twin nebulizers. Results from each device will be compared to evaluate whether current guidelines for the methacholine challenge should be updated for superior standardization.

详细描述

Sixty asthmatics (20 at each testing site: University of Saskatchewan, McMaster University, Laval University) will be recruited to undergo this randomized, triple cross-over study. Three nebulizers will be tested, the Wright, the Bennett-Twin and the new Aeroneb Solo.

Breakdown of study procedure: Participants will undergo three (potentially four) methacholine challenges, one with each nebulizer in randomized order. An additional methacholine challenge may be performed for screening purposes if the participant has not undergone methacholine challenge testing in one of the participating labs in the previous 6 months. The screening challenge will be performed with the standard nebulizer used at the given testing site (i.e. the Wright or the Bennett-Twin).

The methacholine challenges performed with the Wright and Bennett-Twin nebulizers will follow the two-minute tidal breathing protocol as outlined in the 1999 American Thoracic Society Guidelines for Methacholine Challenge Testing. The testing protocol used with the Aeroneb solo will be identical save for a 1 min inhalation period instead of 2 min. Each challenge will be stopped when a participant's forced expiratory volume in 1 second (FEV1) drops at least 20%. This will allow for the determination of the participant's PC20 (provocative concentration of methacholine causing a 20% fall in FEV1), which will subsequently be converted to a PD20 (provocative dose) value. A minimum 24-hour washout period between challenges will be enforced.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

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 greater than 65% predicted

排除标准

  • Use of long-acting bronchodilators within 30 days of Visit 1
  • Pregnant or nursing
  • Cardiovascular problems
  • Respiratory illness within 4 weeks of Visit 1
  • Allergen-induced asthma exacerbation within 4 weeks of Visit 1

研究组 & 干预措施

Wright

Active Comparator

Methacholine challenge performed using the Wright nebulizer

干预措施: Wright nebulizer (Device)

Bennett-Twin

Active Comparator

Methacholine challenge performed using the Bennett-Twin nebulizer

干预措施: Bennett-Twin nebulizer (Device)

Aeroneb Solo

Active Comparator

Methacholine challenge performed using the Aeroneb Solo nebulizer

干预措施: Aeroneb Solo (Device)

结局指标

主要结局

airway responsiveness to methacholine (methacholine pd20)

时间窗: Two weeks

methacholine pd20 data will be compared between nebulizers (Wright, Bennett and Solo). Methacholine PD20 data generated with the Wright nebulizer will serve as the comparator for the methacholine pd20 generated with the Bennett and the Solo nebulizers.

次要结局

未报告次要终点

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 (6)

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