The Potential Added Value of Impulse Oscillometry in Asthma Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in frequency dependance of resistance (FDR) stratified according to change in asthma control test (ACT)
研究概览
简要总结
The goal of this longitudinal observational study is to learn if impulse oscillometry (IOS) has an added value in asthma monitoring in adult asthma patients who are prescribed a change in asthma maintenance therapy. The main questions it aims to answer are:
- Is there a difference in the change in IOS parameters and FEV1 respectively, stratified according to change in asthma control test?
- Is there a difference in the change in IOS parameters and FEV1 respectively, stratified according to change in other questionnaire such as the asthma control questionnaire and the asthma quality of life questionnaire.
- Are the proposed minimal clinically important differences (MCIDs) valid for short follow-up periods (3 - 6 months)?
Participants will undergo lung function testing (full lung function, multiple breath nitrogen washout, impulse oscillometry) and questionnaires (asthma control test, asthma control questionnaire, asthma quality of life questionnaire), once during the baseline visit and once during the follow-up visit three to six months later.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult asthma patients with a scheduled consultation at the outpatient hospital to whom a step-up or step-down of their pharmacological asthma treatment is prescribed
排除标准
- •Unstable asthma (defined as need for oral corticosteroids or (respiratory) antibiotic course in the 4 weeks before inclusion or any major medical issue in the 4 weeks before inclusion)
结局指标
主要结局
Change in frequency dependance of resistance (FDR) stratified according to change in asthma control test (ACT)
时间窗: Once at baseline and 3 - 6 months later during follow-up
Frequency dependance of resistance (FDR) is an impulse oscillometry parameter. FDR is expressed in kPa/(L.s). A lower FDR indicates a clinically better outcome. The ACT is a questionnaire which consists of 5 questions, each evaluated on a 5-point Likert-Scale. Total score ranges between 5 and 25, where a lower score is clinically worse than a higher score.
Change in area of reactance (AX) stratified according to change in asthma control test (ACT)
时间窗: Once at baseline and 3 - 6 months later during follow-up
Area of reactance (AX) is an impulse oscillometry parameter. AX is expressed in kPa/L. A lower AX indicates a clinically better outcome. The ACT is a questionnaire which consists of 5 questions, each evaluated on a 5-point Likert-Scale. Total score ranges between 5 and 25, where a lower score is clinically worse than a higher score.
Change in forced expiratory volume in 1 second (FEV1) stratified according to change in asthma control test (ACT)
时间窗: Once at baseline and 3 - 6 months later during follow-up
Spirometry parameter: forced expiratory volume in 1 second (FEV1). FEV1 is expressed in L. A higher FEV1 indicates a clinically better outcome. The ACT is a questionnaire which consists of 5 questions, each evaluated on a 5-point Likert-Scale. Total score ranges between 5 and 25, where a lower score is clinically worse than a higher score.
次要结局
- Change in forced expiratory volume in 1 second (FEV1) stratified according to change in asthma control questionnaire (ACQ-6)(Once at baseline and 3 - 6 months later during follow-up)
- Change in area of reactance (AX) stratified according to change in asthma quality of life questionnaire (AQLQ)(Once at baseline and 3 - 6 months later during follow-up)
- Change in frequency dependence of resistance (FDR) stratified according to change in asthma control questionnaire (ACQ-6)(Once at baseline and 3 - 6 months later during follow-up)
- Change in area of reactance (AX) over the 3-6 months observation period compared to proposed minimal clinically important differences (MCIDs) (calculated for a one year interval) for AX.(Once at baseline and 3 - 6 months later during follow-up)
- Change in area of reactance (AX) stratified according to change in asthma control questionnaire (ACQ-6)(Once at baseline and 3 - 6 months later during follow-up)
- Change in frequency dependence of resistance (FDR) stratified according to change in asthma quality of life questionnaire (AQLQ)(Once at baseline and 3 - 6 months later during follow-up)
- Change in forced expiratory volume in 1 second (FEV1) stratified according to change in asthma quality of life questionnaire (AQLQ)(Once at baseline and 3 - 6 months later during follow-up)
- Change in frequency dependence of resistance (FDR) over the 3-6 months observation period compared to proposed minimal clinically important differences (MCIDs) (calculated for a one year interval) for FDR.(Once at baseline and 3 - 6 months later during follow-up)