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Researching the Effects of Airway Clearance Therapies in Cystic Fibrosis

NCT03078127 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-03-05

Study results available
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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.

Conditions

Interventions

OTHER

Baseline (Huff-Cough alone)

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.

DEVICE

Oscillatory Positive Expiatory Pressure Device

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.

DEVICE

Whole-Body Vibration Platform

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.

DEVICE

High Frequency Chest Wall Oscillatory Vest

Subjects will use TheVest® using a standardized "Minnesota Protocol" divided into six, four-minute segments, each followed by a Huff-Cough.

Sponsors & Collaborators

  • Cystic Fibrosis Foundation

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Aaron T Trimble, MD · Fellow

  • Scott Donaldson, MD · Associate Professor of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2018-01-10
Completion
2018-01-10
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03078127 on ClinicalTrials.gov