Cystic FibrosisREACT-CFNCT03078127
Researching the Effects of Airway Clearance Therapies in Cystic Fibrosis
A study testing Baseline (Huff-Cough alone), Oscillatory Positive Expiatory Pressure Device and Whole-Body Vibration Platform in people with Cystic Fibrosis and Mucociliary Clearance Defect, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis, Mucociliary Clearance Defect
- What is being tested?
- Baseline (Huff-Cough alone), Oscillatory Positive Expiatory Pressure Device and Whole-Body Vibration Platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 10 Jan 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with confirmed diagnosis of cystic fibrosis aged 18 years and older.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Marsico Clinical Research Center
Chapel Hill, North Carolina, 27517
About this study
Official title: 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.
- Conditions
- Cystic Fibrosis, Mucociliary Clearance Defect
- Being tested
- Baseline (Huff-Cough alone), Oscillatory Positive Expiatory Pressure Device, Whole-Body Vibration Platform, High Frequency Chest Wall Oscillatory Vest
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Also called Aerobika
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
Also called PowerPlate
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.
High Frequency Chest Wall Oscillatory VestDevice
Also called TheVest
Subjects will use TheVest® using a standardized "Minnesota Protocol" divided into six, four-minute segments, each followed by a Huff-Cough.
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Active comparator | 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) Receives: Other: Baseline (Huff-Cough alone); Device: Oscillatory Positive Expiatory Pressure Device; Device: Whole-Body Vibration Platform; Device: High Frequency Chest Wall Oscillatory Vest |
| Sequence B | Active comparator | 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) Receives: Other: Baseline (Huff-Cough alone); Device: Oscillatory Positive Expiatory Pressure Device; Device: Whole-Body Vibration Platform; Device: High Frequency Chest Wall Oscillatory Vest |
| Sequence C | Active comparator | 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) Receives: Other: Baseline (Huff-Cough alone); Device: Oscillatory Positive Expiatory Pressure Device; Device: Whole-Body Vibration Platform; Device: High Frequency Chest Wall Oscillatory Vest |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 274 minutes
Secondary outcomes (6)
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.
Measured: 90 minutes
Change in Rate of MCC
Change in slope of particle clearance curve between pre intervention and ACT period.
Measured: 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.
Measured: 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.
Measured: pre and immediately post intervention (50 mins post inhalation)
Purine Analysis (Adenosine) in Exhaled Breath Condensate (EBC)
Difference of concentration of adenosine (a purine) in EBC between post-ACT and pre-ACT intervention.
Measured: pre and immediately post intervention (50 mins post inhalation)
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.
Measured: pre and immediately post intervention (50 mins post inhalation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start1 Feb 2017
- Primary completion10 Jan 2018
- Study completion10 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Sponsor
- Investigators
- Aaron T Trimble, MD, Principal investigator, FellowScott Donaldson, MD, Principal investigator, Associate Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03078127
- Sponsor's protocol ID
- 16-1813
- Acronym
- REACT-CF
- Status last verified
- Jan 2019
- First submitted
- 27 Feb 2017
- Last updated
- 5 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There are no plans at this time to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Researching the Effects of Airway Clearance Therapies in Cystic Fibrosis (REACT-CF)
- ClinicalTrials.gov ID
- NCT03078127
- Acronym / sponsor ID
- REACT-CF / 16-1813
- Conditions
- Cystic Fibrosis, Mucociliary Clearance Defect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 10 Jan 2018 (actual)
- Study completion
- 10 Jan 2018 (actual)
- First posted
- 13 Mar 2017 (actual)
- Results
- Posted 5 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Active comparator | Other: Baseline (Huff-Cough alone), Device: Oscillatory Positive Expiatory Pressure Device, Device: Whole-Body Vibration Platform, Device: High Frequency Chest Wall Oscillatory VestIn 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 | Active comparator | Other: Baseline (Huff-Cough alone), Device: Oscillatory Positive Expiatory Pressure Device, Device: Whole-Body Vibration Platform, Device: High Frequency Chest Wall Oscillatory VestIn 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 | Active comparator | Other: Baseline (Huff-Cough alone), Device: Oscillatory Positive Expiatory Pressure Device, Device: Whole-Body Vibration Platform, Device: High Frequency Chest Wall Oscillatory VestIn 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with confirmed diagnosis of cystic fibrosis aged 18 years and older.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Sequence A, Sequence B, Sequence C |
| Oscillatory Positive Expiatory Pressure DeviceAlso: AerobikaSubjects 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 | Sequence A, Sequence B, Sequence C |
| Whole-Body Vibration PlatformAlso: PowerPlateSubjects 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 | Sequence A, Sequence B, Sequence C |
| High Frequency Chest Wall Oscillatory VestAlso: TheVestSubjects will use TheVest® using a standardized "Minnesota Protocol" divided into six, four-minute segments, each followed by a Huff-Cough. | Device | Sequence A, Sequence B, Sequence C |
Primary outcome
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).
6 secondary outcomes
Mucociliary Clearance-90
Time frame: 90 minutes
Change in Rate of MCC
Time frame: 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)
Purine Analysis (AMP) in Exhaled Breath Condensate
Time frame: 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)
Purine Analysis (Hypoxanthine) in Exhaled Breath Condensate
Time frame: pre and immediately post intervention (50 mins post inhalation)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There are no plans at this time to share individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron T Trimble, MD principal investigator
Fellow
Scott Donaldson, MD principal investigator
Associate Professor of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline (Huff-Cough alone), Oscillatory Positive Expiatory Pressure Device and Whole-Body Vibration Platform in people with Cystic Fibrosis and Mucociliary Clearance Defect, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mucociliary Clearance-274 (time frame: 274 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.