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

NCT04017312 | Terminated FDA Device

• 1 other identifier: CR-RR-2019-001
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 3

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

Conditions

Bronchiectasis; Bronchiectasis With Acute Exacerbation

Keywords

HFCWO; Airway Clearance therapy; PEP; The Vest®; Non Cystic Fibrosis Bronchiectasis; HFCWC; High frequency chest wall oscillation

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (13)

• 6-minute walk test

  12 months

• Pulmonary function tests

  12 months

• Quality of life measure using the Quality of Life - Bronchiectasis (QoL-B) tool

  12 months

• Time to first exacerbation

  12 months

• Number of exacerbation related hospitalizations

  12 months

Study Arms (2)

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.

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.

Device: Oscillating Positive Expiratory Pressure (OPEP)

Interventions

High Frequency Chest Wall Oscillation 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.

Also known as: The Vest® Airway Clearance System

HFCWO group

Oscillating Positive Expiratory Pressure (OPEP) 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.

Also known as: Acapella®

OPEP group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hill-Rom: lead

Study Sites (3)

NYU Langone Health

New York, New York, 10016, United States

Location

Tennessee Comprehensive Lung and Sleep Center

Nashville, Tennessee, 37075, United States

Location

UT Tyler Health Science Center

Tyler, Texas, 75708, United States

Location

MeSH Terms

Conditions

Bronchiectasis

Interventions

Chest Wall Oscillation

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics

Study Officials

• Ashwin Basavaraj, MD

  New York University Langone Health

  PRINCIPAL INVESTIGATOR

• Clyde Southwell, MD

  Tennessee Comprehensive Lung and Sleep Center

  PRINCIPAL INVESTIGATOR

• Julie Philley, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 12, 2019
• Study Start: August 23, 2019
• Primary Completion: August 6, 2024
• Study Completion: August 6, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)