Assessment of Inspiratory Profiles Through Airflow Resistances Designed to Mimic Inhalers
It is hypothesized that different inhalation profiles (inhalation flow rate versus time curves) result from different forms of patient training. Furthermore, significant inter-subject variability in these profiles should exist that can, under some circumstances, depend on the design of different inhalation devices; this is because dry powder inhalers have different airflow resistances. The investigators also hypothesize that the spread of flow rate versus time profiles for inhalation can be collected. Finally, these profiles can be analyzed from a group of human subjects and used to define a mean and statistical range of inhalation flow rate versus time curves.
The investigators propose to collect the inhalation profiles from 20 'inhaler naïve' healthy volunteers after they have (a) read a typical inhaler package insert and (b) been formally trained in inhaler use by a pharmacist. No drug exposure will occur. The data will be used from this pilot study to (a) show the inter-subject variability in the inhalation profiles used by adults inhaling through realistic airflow resistances (like those in inhalers) following different types of training (b) show how formal training changes inhalation technique and (c) provide a database of typical inspiratory profiles for use and improvement of realistic tests of inhalers in the laboratory. Since pulmonary deposition from inhalers greatly depends upon the way patients inhale through them, this research will result in a database to improve the design and in vitro characterization of inhalers.
研究概览
地位
条件
研究类型
注册 (实际的)
联系人和位置
学习地点
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Virginia
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Richmond、Virginia、美国、23298
- Virginia Commonwealth University, School of Pharmacy
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
- Must be healthy as determined by a health questionnaire
- Must not be currently pregnant (self reported)
- Must not have symptoms of an obstructive or restrictive lung disease or be suffering from allergies or congestion at the time of testing
- Must have Forced 'Expiratory Volume in one second' >'Lower Limit of Normal' predicted
- Must be medically stable with no evidence of acute medical or psychiatric illness,
- Must have never used or been trained to use a dry powder inhaler,
- Must not be currently using any inhaler, nasal spray or drug known to affect lung function, Bronchodilators and decongestants in any form are excluded
- Must be at least 4 feet 10 inch tall,
- Must weigh at least 110 pounds (50 kilograms) and be no more than 264 pounds (120 kilograms)
- Must not currently, or in the past year, have used tobacco products
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
|---|
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Inhaler naive healthy volunteers
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in inhalation flow rate and inhalation volume after the formal training in use of inhaler
大体时间:1 year
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Inhalation Profiles will be collected through different airflow resistance, before and after formal training
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1 year
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合作者和调查者
调查人员
- 首席研究员:Peter R Byron, PhD、Virginia Commonwealth University
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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