BronchiectasisNCT04017312
A Pilot Study to Evaluate the Use of the Vest® System for Treatment of Bronchiectasis Patients in the Home Setting
A study testing High Frequency Chest Wall Oscillation and Oscillating Positive Expiratory Pressure (OPEP) in people with Bronchiectasis and Bronchiectasis With Acute Exacerbation, run by Hill-Rom at 3 sites in United States.
Trial summary
This a 70 patient multi-site non blinded randomized control trial evaluating the use of the Vest® System for treatment of Non-Cystic Fibrosis Bronchiectasis (NCFBE) patients in the home setting. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bronchiectasis, Bronchiectasis With Acute Exacerbation
- What is being tested?
- High Frequency Chest Wall Oscillation and Oscillating Positive Expiratory Pressure (OPEP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Aug 2019to 6 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Radiological diagnosis of Bronchiectasis based on high resolution chest CT scan
- History of at least 2 acute exacerbations or hospitalizations in the past 12 months
- Clinically stable for >2 weeks prior to study entry
- FEV1 >30% predicted
- Age18-80 years
- Signed informed consent
Who cannot join
- Diagnosis of Cystic Fibrosis
- History of bronchiectasis secondary to primary immunodeficiency
- Active pulmonary tuberculosis
- Active treatment of Non-Tuberculous Mycobacterium (NTM)
- Patients currently on home HFCWO treatment or home HFCWO treatment within the past 24 months
- Diagnosed comorbidity or medical indication that would prevent study completion
Show all 11Show fewer
- History of pneumothorax within past 6 months
- History of hemoptysis requiring embolization within past 12 months
- Inability to perform HFCWO therapy or OPEP therapy as directed
- Pregnancy or lactation
- Inability or unwillingness to complete study visits or provide follow-up data as required by the study protocol
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Tennessee Comprehensive Lung and Sleep Center
Nashville, Tennessee, 37075
NYU Langone Health
New York, New York, 10016
UT Tyler Health Science Center
Tyler, Texas, 75708
About this study
Official title: Evaluation of HFCWO Using The Vest® System for Treatment of Non-Cystic Fibrosis Bronchiectasis in the Home Setting
This a 70 patient multi-site non blinded randomized control trial evaluating the use of the Vest® System for treatment of Non-Cystic Fibrosis Bronchiectasis (NCFBE) patients in the home setting. The study will assess outcomes in subjects requiring airway clearance therapy randomized to Oscillating Positive Expiratory Pressure (OPEP) therapy as the control group and High Frequency Chest Wall Oscillation (HFCWO) therapy as the intervention group
Read the detailed description
Patients with NCFBE who require regular home airway clearance therapy will be eligible to be screened for inclusion in the study.
After enrollment, baseline data including demographics, pulmonary related medical history including acute exacerbations (pulmonary-related hospitalizations, ED visits and physician office visits) will be collected Pulmonary function tests (PFTs) (spirometry), and a six-minute walk test will be completed. Quality of Life measures and inflammatory markers and will be collected.
Patients will be randomized to HFCWO or OPEP therapy. Each device will be used within the approved product labeling. These will be the primary airway clearance devices for these patients during the 12 months of the study period.
Following enrollment in the study and completion of a baseline visit, subjects will be seen for follow-up visits.
Detailed documentation of health status and medical history will be collected during the 12-month study period and/or at each study visit to document the occurrence of acute exacerbations and to determine time to first exacerbation, number of hospitalizations and hospitalization days, number of ICU admissions and ICU days, and number of outpatient visits (Physician's office visit, Urgent Care Visits, ED visits)
At 3 months, 6 months and 12 months following the baseline visit, the following tests/procedures will be performed. At each follow-up study visit:
- Acute exacerbations that occurred during the prior 3-month period will be documented/verified
- Pulmonary function will be assessed using standard spirometry to obtain FEV1, FVC and FEV1/FVC.
- 6-minute walk test will be completed to assess respiratory status and endurance
- The QoL-B quality of life survey will be conducted
- A sputum sample will be collected. Sputum samples will be transported to a central lab to test for inflammatory markers (sputum neutrophil elastase in μg/ml).
Mean adherence to the prescribed treatment regimen will be collected and assessed using the validated Modified Self-Reported Medication-Taking Scale. Adherence data in the HFCWO arm will also be collected via the VisiView patient portal.
Adherence results will be collected at the 3-month visit, 6-month visit and 12-month visits.
Any device related adverse events which occur after initial therapy with The Vest® System or Acapella therapy will be recorded.
Any equipment related complaints which occur after initial therapy with The Vest® System or Acapella therapy will be recorded.
At the end of the 12-month study period, all subjects will be given the option of receiving HFCWO therapy for additional 6 month follow up period with outcomes data assessed at the 15-month and 18-month (from baseline visit) time points.
- Being tested
- High Frequency Chest Wall Oscillation, Oscillating Positive Expiratory Pressure (OPEP)
- Keywords
- HFCWO, Airway Clearance therapy, PEP, The Vest®, Non Cystic Fibrosis Bronchiectasis, HFCWC, High frequency chest wall oscillation
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Frequency Chest Wall OscillationDevice
Also called The Vest® Airway Clearance System
High frequency chest wall oscillation (HFCWO) therapy (also known as high-frequency chest-wall compression or HFCWC) is commonly prescribed to provide routine airway clearance in patients with bronchiectasis as well as other patients with a need for regular airway clearance therapy. HFCWO generates high velocity expiratory airflow. This airflow is thought to mobilize secretions by the sheer force created, effecting changes in rheology and moving mucus in a cephalad direction during the oscillation. The Vest® Airway Clearance System, a commonly used device, generates HFCWO using an air pulse generator and an inflatable garment that delivers pressure pulses to the thorax. These pressure pulses within the garment create HFCWO.
Oscillating Positive Expiratory Pressure (OPEP)Device
Also called Acapella®
Oscillating PEP is an airway clearance technique, where the person blows all the way out many times through a device. These types of oscillating PEP devices work in two ways. Firstly, they use resistance to make it more difficult during the breath out, like non-oscillating PEP devices. Oscillating PEP devices also create vibrations when breathing out. The vibrations move mucus from the surface of the airways. After blowing through the device several times, the person will huff and cough to clear the mucus from the lungs.
| Study group | Role | What they receive |
|---|---|---|
| HFCWO group | Active comparator | Subjects in this arm of treatment will use The Vest® as their primary airway clearance modality for the duration of the study. Receives: Device: High Frequency Chest Wall Oscillation |
| OPEP group | Active comparator | Subjects in this arm of treatment will use the Acapella® as their primary airway clearance modality for the duration of the study. Receives: Device: Oscillating Positive Expiratory Pressure (OPEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of acute exacerbations of bronchiectasis
Acute exacerbation periods will be defined as per the European Respiratory Society consensus definition:
- A deterioration in three or more of the following key symptoms for at least 48 h:
- Cough
- Sputum volume and/or consistency
- Sputum purulence
- Breathlessness and/or exercise tolerance
- Fatigue and/or malaise;
- Hemoptysis AND
- A clinician determines that a change in bronchiectasis treatment is required
Measured: 12 months
Secondary outcomes (13)
6-minute walk test
The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise. It will provide information regarding functional capacity and response to therapy.
Measured: 12 months
Pulmonary function tests
FVC, FEV1 and FEV1/FVC as indicators of pulmonary function will be assessed using standard spirometry
Measured: 12 months
Quality of life measure using the Quality of Life - Bronchiectasis (QoL-B) tool
The Quality of Life-Bronchiectasis (QoL-B), a self-administered, patient-reported outcome measure assessing symptoms, functioning and health-related quality of life for patients with NCFBE, contains 37 items on 8 scales (Respiratory Symptoms, Physical, Role, Emotional and Social Functioning, Vitality, Health Perceptions and Treatment Burden)
Measured: 12 months
Time to first exacerbation
The duration of time from initiation of therapy to occurrence of an episode of acute exacerbation of bronchiectasis
Measured: 12 months
Number of exacerbation related hospitalizations
This is the total number of times the subject was admitted as an inpatient due to symptoms of an acute exacerbation
Measured: 12 months
Number of exacerbation related inpatient hospital days
This is the total number of days the subject spent in an inpatient non-ICU setting due to symptoms of an acute exacerbation
Measured: 12 months
Number of exacerbation related ICU admissions
This is the total number of times the subject got admitted into an ICU facility due to symptoms of an acute exacerbation
Measured: 12 months
Number of exacerbation related ICU days
This is the total number of days the subject spent in an ICU due to symptoms of an acute exacerbation
Measured: 12 months
Number of exacerbation related outpatient visits (Physician's office, Urgent Care Visits, ED visits)
This is the total number of times the subject visited an outpatient healthcare facility due to symptoms of an acute exacerbation
Measured: 12 months
Number of courses of antibiotics during episodes of acute exacerbation
This is the total courses of antibiotics prescribed for acute exacerbations
Measured: 12 months
Number of antibiotic use days during episodes of acute exacerbation
This is the total number of days spent on antibiotics for acute exacerbations
Measured: 12 months
Mean adherence to prescribed treatment regimen
Adherence data will be collected using the Modified Self-Reported Medication Taking Scale and verified via the VisiView patient portal
Measured: 12 months
Bronchiectasis related medication
Bronchiectasis related medication data will be collected from subject's electronic medical chart
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start23 Aug 2019
- Primary completion6 Aug 2024
- Study completion6 Aug 2024
Why it stopped: Data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be a non-blinded prospective Randomized Control Trial (RCT) pilot study with subjects requiring airway clearance therapy randomized to Oscillating Positive Expiratory Pressure (OPEP) therapy as the control group and High Frequency Chest Wall Oscillation (HFCWO) therapy as the intervention group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hill-Rom
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ashwin Basavaraj, MD, Principal investigator, NYU Langone HealthClyde Southwell, MD, Principal investigator, Tennessee Comprehensive Lung and Sleep CenterJulie Philley, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017312
- Sponsor's protocol ID
- CR-RR-2019-001
- Status last verified
- Aug 2024
- First submitted
- 9 Jul 2019
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of HFCWO Using The Vest® System for Treatment of Non-Cystic Fibrosis Bronchiectasis in the Home Setting
- ClinicalTrials.gov ID
- NCT04017312
- Acronym / sponsor ID
- CR-RR-2019-001
- Keywords
- HFCWO, Airway Clearance therapy, PEP, The Vest®, Non Cystic Fibrosis Bronchiectasis, HFCWC, High frequency chest wall oscillation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Data
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Hill-RomIndustry (pharma, biotech, devices)
- Study start
- 23 Aug 2019 (actual)
- Primary completion
- 6 Aug 2024 (actual)
- Study completion
- 6 Aug 2024 (actual)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This a 70 patient multi-site non blinded randomized control trial evaluating the use of the Vest® System for treatment of Non-Cystic Fibrosis Bronchiectasis (NCFBE) patients in the home setting. The study will assess outcomes in subjects requiring airway clearance therapy randomized to Oscillating Positive Expiratory Pressure (OPEP) therapy as the control group and High Frequency Chest Wall Oscillation (HFCWO) therapy as the intervention group
Detailed description
Patients with NCFBE who require regular home airway clearance therapy will be eligible to be screened for inclusion in the study.
After enrollment, baseline data including demographics, pulmonary related medical history including acute exacerbations (pulmonary-related hospitalizations, ED visits and physician office visits) will be collected Pulmonary function tests (PFTs) (spirometry), and a six-minute walk test will be completed. Quality of Life measures and inflammatory markers and will be collected.
Patients will be randomized to HFCWO or OPEP therapy. Each device will be used within the approved product labeling. These will be the primary airway clearance devices for these patients during the 12 months of the study period.
Following enrollment in the study and completion of a baseline visit, subjects will be seen for follow-up visits.
Detailed documentation of health status and medical history will be collected during the 12-month study period and/or at each study visit to document the occurrence of acute exacerbations and to determine time to first exacerbation, number of hospitalizations and hospitalization days, number of ICU admissions and ICU days, and number of outpatient visits (Physician's office visit, Urgent Care Visits, ED visits)
At 3 months, 6 months and 12 months following the baseline visit, the following tests/procedures will be performed. At each follow-up study visit:
- Acute exacerbations that occurred during the prior 3-month period will be documented/verified
- Pulmonary function will be assessed using standard spirometry to obtain FEV1, FVC and FEV1/FVC.
- 6-minute walk test will be completed to assess respiratory status and endurance
- The QoL-B quality of life survey will be conducted
- A sputum sample will be collected. Sputum samples will be transported to a central lab to test for inflammatory markers (sputum neutrophil elastase in μg/ml).
Mean adherence to the prescribed treatment regimen will be collected and assessed using the validated Modified Self-Reported Medication-Taking Scale. Adherence data in the HFCWO arm will also be collected via the VisiView patient portal.
Adherence results will be collected at the 3-month visit, 6-month visit and 12-month visits.
Any device related adverse events which occur after initial therapy with The Vest® System or Acapella therapy will be recorded.
Any equipment related complaints which occur after initial therapy with The Vest® System or Acapella therapy will be recorded.
At the end of the 12-month study period, all subjects will be given the option of receiving HFCWO therapy for additional 6 month follow up period with outcomes data assessed at the 15-month and 18-month (from baseline visit) time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will be a non-blinded prospective Randomized Control Trial (RCT) pilot study with subjects requiring airway clearance therapy randomized to Oscillating Positive Expiratory Pressure (OPEP) therapy as the control group and High Frequency Chest Wall Oscillation (HFCWO) therapy as the intervention group
| Arm | Type | Receives |
|---|---|---|
| HFCWO group | Active comparator | Device: High Frequency Chest Wall OscillationSubjects in this arm of treatment will use The Vest® as their primary airway clearance modality for the duration of the study. |
| OPEP group | Active comparator | Device: Oscillating Positive Expiratory Pressure (OPEP)Subjects in this arm of treatment will use the Acapella® as their primary airway clearance modality for the duration of the study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Radiological diagnosis of Bronchiectasis based on high resolution chest CT scan
- History of at least 2 acute exacerbations or hospitalizations in the past 12 months
- Clinically stable for >2 weeks prior to study entry
- FEV1 >30% predicted
- Age18-80 years
Key exclusion criteria (11 listed)
- Diagnosis of Cystic Fibrosis
- History of bronchiectasis secondary to primary immunodeficiency
- Active pulmonary tuberculosis
- Active treatment of Non-Tuberculous Mycobacterium (NTM)
- Patients currently on home HFCWO treatment or home HFCWO treatment within the past 24 months
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 |
|---|---|---|
| High Frequency Chest Wall OscillationAlso: The Vest® Airway Clearance SystemHigh frequency chest wall oscillation (HFCWO) therapy (also known as high-frequency chest-wall compression or HFCWC) is commonly prescribed to provide routine airway clearance in patients with bronchiectasis as well as other patients with a need for regular airway clearance therapy. HFCWO generates high velocity expiratory airflow. This airflow is thought to mobilize secretions by the sheer force created, effecting changes in rheology and moving mucus in a cephalad direction during the oscillation. The Vest® Airway Clearance System, a commonly used device, generates HFCWO using an air pulse generator and an inflatable garment that delivers pressure pulses to the thorax. These pressure pulses within the garment create HFCWO. | Device | HFCWO group |
| Oscillating Positive Expiratory Pressure (OPEP)Also: Acapella®Oscillating PEP is an airway clearance technique, where the person blows all the way out many times through a device. These types of oscillating PEP devices work in two ways. Firstly, they use resistance to make it more difficult during the breath out, like non-oscillating PEP devices. Oscillating PEP devices also create vibrations when breathing out. The vibrations move mucus from the surface of the airways. After blowing through the device several times, the person will huff and cough to clear the mucus from the lungs. | Device | OPEP group |
Primary outcome
Frequency of acute exacerbations of bronchiectasis
Time frame: 12 months
Acute exacerbation periods will be defined as per the European Respiratory Society consensus definition: * A deterioration in three or more of the following key symptoms for at least 48 h: * Cough * Sputum volume and/or consistency * Sputum purulence * Breathlessness and/or exercise tolerance * Fatigue and/or malaise; * Hemoptysis AND * A clinician determines that a change in bronchiectasis treatment is required
13 secondary outcomes
6-minute walk test
Time frame: 12 months
Pulmonary function tests
Time frame: 12 months
Quality of life measure using the Quality of Life - Bronchiectasis (QoL-B) tool
Time frame: 12 months
Time to first exacerbation
Time frame: 12 months
Number of exacerbation related hospitalizations
Time frame: 12 months
Number of exacerbation related inpatient hospital days
Time frame: 12 months
Number of exacerbation related ICU admissions
Time frame: 12 months
Number of exacerbation related ICU days
Time frame: 12 months
Number of exacerbation related outpatient visits (Physician's office, Urgent Care Visits, ED visits)
Time frame: 12 months
Number of courses of antibiotics during episodes of acute exacerbation
Time frame: 12 months
Number of antibiotic use days during episodes of acute exacerbation
Time frame: 12 months
Mean adherence to prescribed treatment regimen
Time frame: 12 months
Bronchiectasis related medication
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: No
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Bronchiectasis
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.
Ashwin Basavaraj, MD principal investigator
NYU Langone Health
Clyde Southwell, MD principal investigator
Tennessee Comprehensive Lung and Sleep Center
Julie Philley, MD principal investigator
University of Texas
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Frequency Chest Wall Oscillation and Oscillating Positive Expiratory Pressure (OPEP) in people with Bronchiectasis and Bronchiectasis With Acute Exacerbation, run by Hill-Rom at 3 sites 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 6 inclusion and 11 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: stopped early, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study was stopped early (reason given: Data). Results are not available in the source record.
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?
Frequency of acute exacerbations of bronchiectasis (time frame: 12 months). 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 21 Aug 2024.