Brief Title
A Pilot Study to Evaluate the Use of the Vest® System for Treatment of Bronchiectasis Patients in the Home Setting
Official Title
Evaluation of HFCWO Using The Vest® System for Treatment of Non-Cystic Fibrosis Bronchiectasis in the Home Setting
Brief 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. 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, subjects randomized to the PEP group will be given
the option of receiving HFCWO therapy for a 6 month follow up period with outcomes data
assessed at the 6-month time point.
Study Type
Interventional
Primary Outcome
Frequency of acute exacerbations of bronchiectasis
Secondary Outcome
6-minute walk test
Condition
Bronchiectasis
Intervention
High Frequency Chest Wall Oscillation
Study Arms / Comparison Groups
HFCWO group
Description: Subjects in this arm of treatment will use The Vest® as their primary airway clearance modality for the duration of the study.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
70
Start Date
August 23, 2019
Completion Date
November 2020
Primary Completion Date
November 2020
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Diagnosis of Cystic Fibrosis
- History of bronchiectasis secondary to primary immunodeficiency
- Active pulmonary tuberculosis
- Active treatment of Non-Tuberculous Mycobacterium (NTM)
- Patients currently on HFCWO treatment
- Diagnosed comorbidity or medical indication that would prevent study completion
- 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
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Mark Jennings, MD, 6514159306, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04017312
Organization ID
CR-RR-2019-001
Responsible Party
Sponsor
Study Sponsor
Hill-Rom
Study Sponsor
Mark Jennings, MD, Principal Investigator, Johns Hopkins University
Verification Date
February 2020