Researching the Effects of Airway Clearance Therapies in Cystic Fibrosis (REACT-CF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Mucociliary Clearance-274
研究概览
简要总结
This is a pilot study investigating the effectiveness and clinical efficacy of airway clearance therapy (ACT) in cystic fibrosis (CF). Enrolled subjects will undergo measurements of mucociliary clearance (MCC) and exhaled biomarkers at baseline and after 3 different forms of ACT: high frequency chest wall oscillatory vest, oscillatory positive expiratory pressure device, and whole-body vibration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •Adults with confirmed diagnosis of cystic fibrosis aged 18 years and older.
排除标准
- •Pregnant or lactating women,
- •Individuals with severe lung disease (FEV1 <30%), or with exacerbations of lung disease requiring antibiotics or medication change within four weeks prior to enrolment.
- •Individuals unable to use vest-based HFCWO, OPEP device, or who require oxygen supplementation at rest.
- •Individuals with significant balance or gait impairment preventing them from tolerating being positioned on a vibrating platform.
研究组 & 干预措施
Sequence A
In this arm, the interventions were performed in the following order:
Baseline (prior to randomization), Whole body vibration, High Frequency Chest Wall Oscillation (HFCWO, aka "Vest" or TheVest®), Oscillatory Positive Expiratory Pressure (OPEP) (note this is different than the sequence shown in the example latin square shown in the included protocol, as that was meant to serve as an example -- actual randomization and formulation of the employed latin square / sequence generator was performed following completion of the protocol)
干预措施: Baseline (Huff-Cough alone) (Other)
Sequence A
In this arm, the interventions were performed in the following order:
Baseline (prior to randomization), Whole body vibration, High Frequency Chest Wall Oscillation (HFCWO, aka "Vest" or TheVest®), Oscillatory Positive Expiratory Pressure (OPEP) (note this is different than the sequence shown in the example latin square shown in the included protocol, as that was meant to serve as an example -- actual randomization and formulation of the employed latin square / sequence generator was performed following completion of the protocol)
干预措施: Oscillatory Positive Expiatory Pressure Device (Device)
Sequence A
In this arm, the interventions were performed in the following order:
Baseline (prior to randomization), Whole body vibration, High Frequency Chest Wall Oscillation (HFCWO, aka "Vest" or TheVest®), Oscillatory Positive Expiratory Pressure (OPEP) (note this is different than the sequence shown in the example latin square shown in the included protocol, as that was meant to serve as an example -- actual randomization and formulation of the employed latin square / sequence generator was performed following completion of the protocol)
干预措施: Whole-Body Vibration Platform (Device)
Sequence A
In this arm, the interventions were performed in the following order:
Baseline (prior to randomization), Whole body vibration, High Frequency Chest Wall Oscillation (HFCWO, aka "Vest" or TheVest®), Oscillatory Positive Expiratory Pressure (OPEP) (note this is different than the sequence shown in the example latin square shown in the included protocol, as that was meant to serve as an example -- actual randomization and formulation of the employed latin square / sequence generator was performed following completion of the protocol)
干预措施: High Frequency Chest Wall Oscillatory Vest (Device)
Sequence B
In this arm, the interventions were performed in the following order:
Baseline (prior to randomization), HFCWO, OPEP, Whole body vibration (note this is different than the sequence shown in the example latin square shown in the included protocol, as that was meant to serve as an example -- actual randomization and formulation of the employed latin square / sequence generator was performed following completion of the protocol)
干预措施: Baseline (Huff-Cough alone) (Other)
Sequence B
In this arm, the interventions were performed in the following order:
Baseline (prior to randomization), HFCWO, OPEP, Whole body vibration (note this is different than the sequence shown in the example latin square shown in the included protocol, as that was meant to serve as an example -- actual randomization and formulation of the employed latin square / sequence generator was performed following completion of the protocol)
干预措施: Oscillatory Positive Expiatory Pressure Device (Device)
Sequence B
In this arm, the interventions were performed in the following order:
Baseline (prior to randomization), HFCWO, OPEP, Whole body vibration (note this is different than the sequence shown in the example latin square shown in the included protocol, as that was meant to serve as an example -- actual randomization and formulation of the employed latin square / sequence generator was performed following completion of the protocol)
干预措施: Whole-Body Vibration Platform (Device)
Sequence B
In this arm, the interventions were performed in the following order:
Baseline (prior to randomization), HFCWO, OPEP, Whole body vibration (note this is different than the sequence shown in the example latin square shown in the included protocol, as that was meant to serve as an example -- actual randomization and formulation of the employed latin square / sequence generator was performed following completion of the protocol)
干预措施: High Frequency Chest Wall Oscillatory Vest (Device)
Sequence C
In this arm, the interventions were performed in the following order:
Baseline (prior to randomization), OPEP, Whole body vibration, HFCWO (note this is different than the sequence shown in the example latin square shown in the included protocol, as that was meant to serve as an example -- actual randomization and formulation of the employed latin square / sequence generator was performed following completion of the protocol)
干预措施: Baseline (Huff-Cough alone) (Other)
Sequence C
In this arm, the interventions were performed in the following order:
Baseline (prior to randomization), OPEP, Whole body vibration, HFCWO (note this is different than the sequence shown in the example latin square shown in the included protocol, as that was meant to serve as an example -- actual randomization and formulation of the employed latin square / sequence generator was performed following completion of the protocol)
干预措施: Oscillatory Positive Expiatory Pressure Device (Device)
Sequence C
In this arm, the interventions were performed in the following order:
Baseline (prior to randomization), OPEP, Whole body vibration, HFCWO (note this is different than the sequence shown in the example latin square shown in the included protocol, as that was meant to serve as an example -- actual randomization and formulation of the employed latin square / sequence generator was performed following completion of the protocol)
干预措施: Whole-Body Vibration Platform (Device)
Sequence C
In this arm, the interventions were performed in the following order:
Baseline (prior to randomization), OPEP, Whole body vibration, HFCWO (note this is different than the sequence shown in the example latin square shown in the included protocol, as that was meant to serve as an example -- actual randomization and formulation of the employed latin square / sequence generator was performed following completion of the protocol)
干预措施: High Frequency Chest Wall Oscillatory Vest (Device)
结局指标
主要结局
Mucociliary Clearance-274
时间窗: 274 minutes
As described in the protocol, gamma scintigraphy was used to measure clearance of particles from the whole right lung region of interest over 274 minutes. The primary outcome for this study was the area under the particle clearance curve from time 0 to 274 minutes post-inhalation (normalized to time by dividing by 274) and expressed as a percent, representing total average rate of mucociliary clearance (MCC).
次要结局
- Change in Rate of MCC(pre-ACT (0-16 mins) and during ACT (16-50 mins))
- Purine Analysis (AMP) in Exhaled Breath Condensate(pre and immediately post intervention (50 mins post inhalation))
- Change in Fraction of Exhaled Nitric Oxide (FENO)(pre and immediately post intervention (50 mins post inhalation))
- Purine Analysis (Hypoxanthine) in Exhaled Breath Condensate(pre and immediately post intervention (50 mins post inhalation))
- Mucociliary Clearance-90(90 minutes)
- Purine Analysis (Adenosine) in Exhaled Breath Condensate (EBC)(pre and immediately post intervention (50 mins post inhalation))