A Pilot Study to Evaluate the Use of the Vest® System for Treatment of Bronchiectasis Patients in the Home Setting

NCT ID: NCT04017312

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-23
• Study Completion Date: 2024-08-06

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.

Conditions

Bronchiectasis; Bronchiectasis With Acute Exacerbation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HFCWO group

Subjects in this arm of treatment will use The Vest® as their primary airway clearance modality for the duration of the study.

Group Type: ACTIVE_COMPARATOR

High Frequency Chest Wall Oscillation

Intervention Type: DEVICE

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.

OPEP group

Subjects in this arm of treatment will use the Acapella® as their primary airway clearance modality for the duration of the study.

Group Type: ACTIVE_COMPARATOR

Oscillating Positive Expiratory Pressure (OPEP)

Intervention Type: DEVICE

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.

Interventions

High Frequency Chest Wall Oscillation

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.

Intervention Type: DEVICE

Oscillating Positive Expiratory Pressure (OPEP)

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.

Intervention Type: DEVICE

Other Intervention Names

The Vest® Airway Clearance System; Acapella®

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hill-Rom

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashwin Basavaraj, MD

Role: PRINCIPAL_INVESTIGATOR

New York University Langone Health

Clyde Southwell, MD

Role: PRINCIPAL_INVESTIGATOR

Tennessee Comprehensive Lung and Sleep Center

Julie Philley, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

NYU Langone Health

New York, New York, United States

Tennessee Comprehensive Lung and Sleep Center

Nashville, Tennessee, United States

UT Tyler Health Science Center

Tyler, Texas, United States

Countries

United States

Other Identifiers

CR-RR-2019-001

Identifier Type: -

Identifier Source: org_study_id