Clinical trial NCT04017312: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bronchiectasis
Bronchiectasis With Acute Exacerbation
Keywords: HFCWO
Airway Clearance therapy
PEP
The Vest®
Non Cystic Fibrosis Bronchiectasis
HFCWC
High frequency chest wall oscillation
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2019-07-12
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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, 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.

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 home HFCWO treatment or home HFCWO treatment within the past 24 months
* 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

Primary outcomes:
measure: Frequency of acute exacerbations of bronchiectasis
timeFrame: 12 months
Secondary outcomes:
measure: 6-minute walk test
timeFrame: 12 months
measure: Pulmonary function tests
timeFrame: 12 months
measure: Quality of life measure using the Quality of Life - Bronchiectasis (QoL-B) tool
timeFrame: 12 months
measure: Time to first exacerbation
timeFrame: 12 months
measure: Number of exacerbation related hospitalizations
timeFrame: 12 months
measure: Number of exacerbation related inpatient hospital days
timeFrame: 12 months
measure: Number of exacerbation related ICU admissions
timeFrame: 12 months
measure: Number of exacerbation related ICU days
timeFrame: 12 months
measure: Number of exacerbation related outpatient visits (Physician's office, Urgent Care Visits, ED visits)
timeFrame: 12 months
measure: Number of courses of antibiotics during episodes of acute exacerbation
timeFrame: 12 months
measure: Number of antibiotic use days during episodes of acute exacerbation
timeFrame: 12 months
measure: Mean adherence to prescribed treatment regimen
timeFrame: 12 months
measure: Bronchiectasis related medication
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Nashville
country: United States
facility: Tennessee Comprehensive Lung and Sleep Center
state: Tennessee
city: Tyler
country: United States
facility: UT Tyler Health Science Center
state: Texas
Study officials:
affiliation: New York University Langone Health
name: Ashwin Basavaraj, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tennessee Comprehensive Lung and Sleep Center
name: Clyde Southwell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas
name: Julie Philley, MD
role: PRINCIPAL_INVESTIGATOR
References: