Predictive Value of Peak Inspiratory Flow Rate Derived From Spirometry to Determine the Patient's Ability to Produce Peak Inspiratory Flow Rate to Overcome the Resistance of Current Dry Powders Inhalers.
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- PIFspiro
研究概览
简要总结
The main aim is to study correlations between Peak inspiratory flow measured during a spirometry (PIFspiro) and Peak inspiratory flow measured over a pre-set resistance (PIFresist) in COPD patients and severe asthma patients. PIFresist will be measured using 5 different resistances, representing all DPI's relevant for the treatment of obstructive lung diseases. If this shows a distinct relationship between PIFspiro and PIFresist, PIFspiro cut-off points will be sought in an attempt to predict which patients are likely to be able to produce optimal flows for DPI use. If successful, this will make the actual measurement of PIFresist redundant in clinical practice. Also the relationship between PIFresist and device internal resistance in addition to PIFspiro (which corresponds to a very low resistance) will be examined.
详细描述
The correct use of dry powder inhalers (DPI) crucially depends on the peak inspiratory flow (PIF) that the patient can generate when overcoming internal resistance of the inhaler device.
It has been shown that some patients cannot achieve sufficient peak inspiratory flows with some DPI's, especially in the elderly population. The In-check Dial device (Clement Clarke International Ltd, Harlow, UK) allows to measure these inspiratory flows for different pre-set resistances, representing different DPI's.
Study design: interventional, single center, single visit study
30 Severe asthmatics and 70 COPD patients will be recruited in the UZ Brussel respiratory outpatient clinic.
All participants will provide written informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe asthmatics (M/F; > 20 y) entering the Belgian Severe Asthma Registry (BSAR)
- •COPD patients (GOLD stage II-IV; M/F; > 40 y)
排除标准
- •Inability to perform spirometry
研究组 & 干预措施
Severe asthma patients; COPD patients
Cross sectional study Lung function measurement
干预措施: In-check Dial device (Clement Clarke International Ltd, Harlow, UK) (Device)
结局指标
主要结局
PIFspiro
时间窗: At inclusion (D0)
PIFspiro (L/s): PIF measurement from standardized spirometry (3 flow-volume measurements);
PIFresist
时间窗: At inclusion (D0)
PIFresist (L/min): PIF from In-check Dial (5 flow measurements with flow restrictor in 5 different positions)
次要结局
未报告次要终点