Researching the Effects of Airway Clearance Therapies in Cystic Fibrosis

Not Applicable

Completed

• Conditions: Cystic Fibrosis; Mucociliary Clearance Defect
• Interventions: Other: Baseline (Huff-Cough alone); Device: Oscillatory Positive Expiatory Pressure Device; Device: Whole-Body Vibration Platform; Device: High Frequency Chest Wall Oscillatory Vest

• Registration Number: NCT03078127
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2017-02-27
• Study First Submitted QC: 2017-03-07
• Study First Posted: 2017-03-13
• Primary Completion: 2018-01-10
• Study Completion: 2018-01-10
• Status Verified: 2019-01
• Results First Submitted: 2019-01-09
• Results First Submitted QC: 2019-02-13
• Last Update Submitted: 2019-02-13
• Results First Posted: 2019-03-05
• Last Update Posted: 2019-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence A	Oscillatory Positive Expiatory Pressure Device	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)
Sequence C	Baseline (Huff-Cough alone)	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)
Sequence A	High Frequency Chest Wall Oscillatory Vest	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)
Sequence A	Baseline (Huff-Cough alone)	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)
Sequence B	Oscillatory Positive Expiatory Pressure Device	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)
Sequence B	Whole-Body Vibration Platform	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)
Sequence C	Oscillatory Positive Expiatory Pressure Device	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)
Sequence A	Whole-Body Vibration Platform	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)
Sequence B	High Frequency Chest Wall Oscillatory Vest	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)
Sequence B	Baseline (Huff-Cough alone)	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)
Sequence C	Whole-Body Vibration Platform	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)
Sequence C	High Frequency Chest Wall Oscillatory Vest	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)

Primary Outcome Measures

Name	Time	Method
Mucociliary Clearance-274	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).

Secondary Outcome Measures

Name	Time	Method
Change in Rate of MCC	pre-ACT (0-16 mins) and during ACT (16-50 mins)	Change in slope of particle clearance curve between pre intervention and ACT period.
Purine Analysis (AMP) in Exhaled Breath Condensate	pre and immediately post intervention (50 mins post inhalation)	Exhaled breath condensate was collected using a commercial device for this purpose. Concentrations of the purine adenosine monophosphate (AMP) and urea in this liquid were determined using mass spectrometry. This outcome was the difference in concentrations of AMP normalized to urea in this exhaled breath condensate between post-ACT and pre-ACT intervention.
Change in Fraction of Exhaled Nitric Oxide (FENO)	pre and immediately post intervention (50 mins post inhalation)	FENO measurements were obtained pre- and post- intervention. The difference of post- vs pre- ACT FENO was reported.
Purine Analysis (Hypoxanthine) in Exhaled Breath Condensate	pre and immediately post intervention (50 mins post inhalation)	Difference of concentration of hypoxanthine (a purine) in Exhaled Breath Condensate between post-ACT and pre-ACT intervention.
Mucociliary Clearance-90	90 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. This outcome for this study was the area under the particle clearance curve from time 0 to 90 minutes post-inhalation (normalized to time by dividing by 90) and expressed as a percent, representing average rate of mucociliary clearance (MCC) over 90 minutes.
Purine Analysis (Adenosine) in Exhaled Breath Condensate (EBC)	pre and immediately post intervention (50 mins post inhalation)	Difference of concentration of adenosine (a purine) in EBC between post-ACT and pre-ACT intervention.

Trial Locations

Locations (1)

Marsico Clinical Research Center; 🇺🇸 Chapel Hill, North Carolina, United States