Researching the Effects of Airway Clearance Therapies in Cystic Fibrosis

University of North Carolina, Chapel Hill10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Cystic Fibrosis Mucociliary Clearance Defect

Interventions

Baseline (Huff-Cough alone)OTHER

Subjects will provide two "huffs" (forced expiratory maneuver with open glottis) followed by a cough every six minutes for a total of six Huff-Coughs.

Oscillatory Positive Expiatory Pressure DeviceDEVICE

Subjects will use an Areobika® branded OPEP device (10 breaths through highest tolerated resistance) prior to undergoing a Huff-Cough. Subjects will use the device six times every six minutes.

Whole-Body Vibration PlatformDEVICE

Subjects will be seated on a PowerPlate® whole-body vibration platform for 90 seconds prior to Huff-Cough. Six intervals on the platform will be completed six minutes apart.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Marsico Clinical Research Center

Chapel Hill, North Carolina, United States

Outcomes

Primary Outcomes

Mucociliary Clearance-274

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).

Time frame: 274 minutes

Secondary Outcomes

Mucociliary Clearance-90

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.

Time frame: 90 minutes

Change in Rate of MCC

Change in slope of particle clearance curve between pre intervention and ACT period.

Time frame: pre-ACT (0-16 mins) and during ACT (16-50 mins)

Change in Fraction of Exhaled Nitric Oxide (FENO)

FENO measurements were obtained pre- and post- intervention. The difference of post- vs pre- ACT FENO was reported.

Time frame: pre and immediately post intervention (50 mins post inhalation)

Purine Analysis (AMP) in Exhaled Breath Condensate

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.

Data from ClinicalTrials.gov

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