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

February 13, 2019 updated by: University of North Carolina, Chapel Hill

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27517
        • Marsico Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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)
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.
Other Names:
  • Aerobika
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.
Other Names:
  • PowerPlate
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.
Other Names:
  • TheVest
Active Comparator: 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)
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.
Other Names:
  • Aerobika
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.
Other Names:
  • PowerPlate
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.
Other Names:
  • TheVest
Active Comparator: 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)
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.
Other Names:
  • Aerobika
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.
Other Names:
  • PowerPlate
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.
Other Names:
  • TheVest

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mucociliary Clearance-274
Time Frame: 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).
274 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mucociliary Clearance-90
Time Frame: 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.
90 minutes
Change in Rate of MCC
Time Frame: pre-ACT (0-16 mins) and during ACT (16-50 mins)
Change in slope of particle clearance curve between pre intervention and ACT period.
pre-ACT (0-16 mins) and during ACT (16-50 mins)
Change in Fraction of Exhaled Nitric Oxide (FENO)
Time Frame: 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.
pre and immediately post intervention (50 mins post inhalation)
Purine Analysis (AMP) in Exhaled Breath Condensate
Time Frame: 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.
pre and immediately post intervention (50 mins post inhalation)
Purine Analysis (Adenosine) in Exhaled Breath Condensate (EBC)
Time Frame: 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.
pre and immediately post intervention (50 mins post inhalation)
Purine Analysis (Hypoxanthine) in Exhaled Breath Condensate
Time Frame: 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.
pre and immediately post intervention (50 mins post inhalation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Cystic Fibrosis Foundation

Investigators

  • Principal Investigator: Aaron T Trimble, MD, Fellow
  • Principal Investigator: Scott Donaldson, MD, Associate Professor of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

January 10, 2018

Study Completion (Actual)

January 10, 2018

Study Registration Dates

First Submitted

February 27, 2017

First Submitted That Met QC Criteria

March 7, 2017

First Posted (Actual)

March 13, 2017

Study Record Updates

Last Update Posted (Actual)

March 5, 2019

Last Update Submitted That Met QC Criteria

February 13, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-1813

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There are no plans at this time to share individual participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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