Back to resultsResearching the Effects of Airway Clearance Therapies in Cystic Fibrosis (REACT-CF)
Primary Purpose
Cystic Fibrosis, Mucociliary Clearance Defect
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Baseline (Huff-Cough alone)
Oscillatory Positive Expiatory Pressure Device
Whole-Body Vibration Platform
High Frequency Chest Wall Oscillatory Vest
Sponsored by
About this trial
This is an interventional basic science trial for Cystic Fibrosis
Eligibility Criteria
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.
Sites / Locations
- Marsico Clinical Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Sequence A
Sequence B
Sequence C
Arm 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)
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)
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)
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Change in Rate of MCC
Change in slope of particle clearance curve between pre intervention and ACT period.
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.
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.
Purine Analysis (Adenosine) in Exhaled Breath Condensate (EBC)
Difference of concentration of adenosine (a purine) in EBC between post-ACT and pre-ACT intervention.
Purine Analysis (Hypoxanthine) in Exhaled Breath Condensate
Difference of concentration of hypoxanthine (a purine) in Exhaled Breath Condensate between post-ACT and pre-ACT intervention.
Full Information
NCT ID
NCT03078127
First Posted
February 27, 2017
Last Updated
February 13, 2019
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Cystic Fibrosis Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03078127
Brief Title
Researching the Effects of Airway Clearance Therapies in Cystic Fibrosis
Acronym
REACT-CF
Official Title
Researching the Effects of Airway Clearance Therapies in Cystic Fibrosis (REACT-CF)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
January 10, 2018 (Actual)
Study Completion Date
January 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Cystic Fibrosis Foundation
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Mucociliary Clearance Defect
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
All subjects will undergo baseline testing, followed by study procedures for three separate interventions, with subjects randomized into three arms in which a different sequence in which to complete the studies.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence A
Arm Type
Active Comparator
Arm 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)
Arm Title
Sequence B
Arm Type
Active Comparator
Arm 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)
Arm Title
Sequence C
Arm Type
Active Comparator
Arm 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)
Intervention Type
Other
Intervention Name(s)
Baseline (Huff-Cough alone)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Oscillatory Positive Expiatory Pressure Device
Other Intervention Name(s)
Aerobika
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Whole-Body Vibration Platform
Other Intervention Name(s)
PowerPlate
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
High Frequency Chest Wall Oscillatory Vest
Other Intervention Name(s)
TheVest
Intervention Description
Subjects will use TheVest® using a standardized "Minnesota Protocol" divided into six, four-minute segments, each followed by a Huff-Cough.
Primary Outcome Measure Information:
Title
Mucociliary Clearance-274
Description
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 Outcome Measure Information:
Title
Mucociliary Clearance-90
Description
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
Title
Change in Rate of MCC
Description
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)
Title
Change in Fraction of Exhaled Nitric Oxide (FENO)
Description
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)
Title
Purine Analysis (AMP) in Exhaled Breath Condensate
Description
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.
Time Frame
pre and immediately post intervention (50 mins post inhalation)
Title
Purine Analysis (Adenosine) in Exhaled Breath Condensate (EBC)
Description
Difference of concentration of adenosine (a purine) in EBC between post-ACT and pre-ACT intervention.
Time Frame
pre and immediately post intervention (50 mins post inhalation)
Title
Purine Analysis (Hypoxanthine) in Exhaled Breath Condensate
Description
Difference of concentration of hypoxanthine (a purine) in Exhaled Breath Condensate between post-ACT and pre-ACT intervention.
Time Frame
pre and immediately post intervention (50 mins post inhalation)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron T Trimble, MD
Organizational Affiliation
Fellow
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Scott Donaldson, MD
Organizational Affiliation
Associate Professor of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marsico Clinical Research Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There are no plans at this time to share individual participant data.
Learn more about this trial
Researching the Effects of Airway Clearance Therapies in Cystic Fibrosis
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