Researching the Effects of Airway Clearance Therapies in Cystic Fibrosis (REACT-CF)

University of North Carolina (UNC)

Status: Completed

Conditions: Cystic Fibrosis; Mucociliary Clearance Defect

Treatments: Device: High Frequency Chest Wall Oscillatory Vest; Other: Baseline (Huff-Cough alone); Device: Whole-Body Vibration Platform; Device: Oscillatory Positive Expiatory Pressure Device

Study type: Interventional

Funder types: Other

Identifiers

NCT03078127

16-1813

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults with confirmed diagnosis of cystic fibrosis aged 18 years and older.

Exclusion criteria

• 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 3 patient groups

Sequence A

Active Comparator group

Description:

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)

Treatment:

Device: Oscillatory Positive Expiatory Pressure Device

Device: Whole-Body Vibration Platform

Device: High Frequency Chest Wall Oscillatory Vest

Other: Baseline (Huff-Cough alone)

Sequence B

Active Comparator group

Description:

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)

Treatment:

Device: Oscillatory Positive Expiatory Pressure Device

Device: Whole-Body Vibration Platform

Device: High Frequency Chest Wall Oscillatory Vest

Other: Baseline (Huff-Cough alone)

Sequence C

Active Comparator group

Description:

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)

Treatment:

Device: Oscillatory Positive Expiatory Pressure Device

Device: Whole-Body Vibration Platform

Device: High Frequency Chest Wall Oscillatory Vest

Other: Baseline (Huff-Cough alone)