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临床试验/NCT05264441
NCT05264441Unknown不适用

Choice of Inhalation Device in Asthma and COPD Patients

Universitair Ziekenhuis Brussel0 个研究点目标入组 140 人开始时间: 2022年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
140
主要终点
Proportion of patients with device mismatch

研究概览

简要总结

In this study, asthma and COPD patients will be invited to participate after the consultation with their pulmonologist.

The intervention consists of three steps. The first step is to perform a deep inspiration. The second step is to demonstrate the correct use of a pMDI. The third step is to perform a strong inspiration into the In-Check Dial device over 5 different resistances.

详细描述

The study will take place in the respiratory outpatient clinic. Patients will be invited to participate in the study after the consultation with the pulmonologist. All pulmonologists have a flowchart regarding the optimal choice of inhaler at their disposition.

Patients will be provided sufficient time to read the informed consent file and to ask questions about the study. After giving their informed consent they will be screened for eligibility by an investigator. Demographic data and characteristics will be retrieved from the medical record (EMD) of study participants.

The intervention will consist of three different steps.

First, the patient will perform a deep voluntary inspiration. The patient's ability to perform this inspiration will be assessed and scored by the investigator.

Secondly, the peak inspiratory flows (PIF) will be measured with an In-check Dial device over 5 different resistances.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •COPD patients (GOLD II-IV)
  • •Patients with severe asthma
  • •Patients with mild-to moderate asthma aged < 70y
  • •Patients with asthma aged ≥ 70y

排除标准

  • •Patients with asthma or COPD not on inhaled therapy for maintenance treatment
  • •Patients younger than 18y
  • •Patients unable to give their informed consent due to mental or physical disability
  • •Patients who don't speak French or Dutch

研究组 & 干预措施

Asthma and COPD patients

Other

There will be only 1 arm in this study. COPD and asthma patients will be in the same arm.

干预措施: In-Check DIAL G16 (Device)

结局指标

主要结局

Proportion of patients with device mismatch

时间窗: up to 2 months

Data from COPD and asthma patients will be compared

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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