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

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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