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Clinical Effectiveness Of High Frequency Chest Wall Oscillation (HFCWO) In A Bronchiectasis Population (HFCWO)

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ClinicalTrials.gov Identifier: NCT04271969
Recruitment Status : Recruiting
First Posted : February 17, 2020
Last Update Posted : March 27, 2023
Sponsor:
Collaborator:
University of Alabama at Birmingham
Information provided by (Responsible Party):
Electromed, Inc.

Study Description
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Brief Summary:
The primary objective is to compare the patient's baseline QoL prior to HFCWO use against the patient's QoL at various study timepoints over a one-year period of HFCWO use.

Condition or disease Intervention/treatment
Bronchiectasis Device: SmartVest Airway Clearance System

Detailed Description:
This study will use a prospective interventional comparative study design using the patient's quality of life (QoL) as the primary study endpoint to determine HFCWO affect. The study will compare the patient's QoL baseline (established at enrollment prior to HFCWO treatment) to the QoL measured at various timepoints (enrollment, 2 months, 6 months and 12 months) over a one-year period whilst receiving HFCWO treatment. In addition, a baseline for the secondary endpoints will established at enrollment for comparison to measurements taken at various timepoints over a one-year period whilst receiving HFCWO treatment. The patient's medical records will be used to establish prior histories of exacerbation rates for comparison to exacerbation rates experienced after one year of HFCWO treatment. Patients will serve as their own control.
Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Effectiveness Of High Frequency Chest Wall Oscillation (HFCWO) In A Bronchiectasis Population
Actual Study Start Date : February 18, 2020
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023
Groups and Cohorts
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Intervention Details:
  • Device: SmartVest Airway Clearance System
    Pulmonary airway clearance of retained mucus via high frequency chest wall oscillation (SmartVest)

Outcome Measures
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Primary Outcome Measures :
  1. Quality of Life (QoL): Quality of Life-Bronchiectasis (QOL-B) questionnaire [ Time Frame: 1 year ]

    The primary endpoint is the subject's quality of life (QoL) using the Quality of Life-Bronchiectasis (QOL-B) questionnaire as the measurement tool. QoL measured at enrollment (baseline) will be compared to QoL measured at 2 months, 6 months and 1 year.

    The previously validated questionnaire is titled "Quality of Life Questionnaire - Bronchiectasis". The Likert style questionnaire asks the subject to subjectively rank their symptoms using a 4 scale base ranging from "a lot of difficulty" to "no difficulty" and "always" to "never".



Secondary Outcome Measures :
  1. Clinical Measurements [ Time Frame: 1 year ]

    1. Exacerbation rates

      a. Pre HFCWO exacerbation rates will be established by review of the patient's medical records. Post HFCWO will recorded at 2 months, 6 months and 1 year.

    2. Exacerbation frequency

      1. The time to the subject's next exacerbation will be recorded for comparison pre to post HFCWO
      2. Lung function (FEV1, FVC, FEF25-75) measured by standard spirometry
      3. Sputum production measured by using the Breathlessness, Cough and Sputum Scale (BCSS) questionnaire
      4. Patient adherence to HFCWO treatment measured by SmartVest Connect wireless feature
      5. Six-minute walk test measured using American Thoracic Society standard test guidelines/protocol
      6. Radiographic changes compare patient's original high-resolution computerized tomography (HRCT) taken to initially


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary care clinic
Criteria

Inclusion Criteria:

  1. 18 years of age or older
  2. Previous diagnosis of bronchiectasis confirmed by HRCT within the last 6 months
  3. Patients must have at least 6 months of medical records related to bronchiectasis
  4. Patients must be stable and currently on a standard of care regimen for bronchiectasis such as hypertonic saline and/or PEP
  5. Patients with 1 or more exacerbations within the last 12 months
  6. Previous and existing productive cough
  7. No previous HFCWO use

Exclusion Criteria:

  1. Patients who are known to have cystic fibrosis
  2. Patients who are known to have primary ciliary dyskinesia (PCD)
  3. Patients with chronic obstructive pulmonary disease (COPD) without bronchiectasis
  4. Patients breathing via an artificial airway
  5. Severe bronchospasm based on exam or history
  6. Any comorbidity(ies) or contraindications that would normally complicate tolerating HFCWO treatment
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04271969


Contacts
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Contact: Chet Sievert 651-246-8621 csievert@electromed.com

Locations
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United States, Alabama
University of Alabama - Birmingham (UAB University Hospital) Recruiting
Birmingham, Alabama, United States, 35233-2110
Contact: George Solomon, MD    205-996-4975    gsolomon@uabmc.edu   
Contact: Brandie Cline       brandiecline@uabmc.edu   
United States, Georgia
Emory University School of Medicine Recruiting
Atlanta, Georgia, United States, 30342
Contact: Colin Swenson, MD       colin.swenson@emory.edu   
Contact: Elizabeth Cox, CCMA    404-251-1705    elizabeth.m.cox@emory.edu   
United States, Pennsylvania
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Gerard Criner, MD    800-836-7536    gerard.criner@tuhs.temple.edu   
Contact: Kim Selwood, BSN, RN    215.707.2291    Kim.Selwood@tuhs.temple.edu   
United States, Texas
The University of Texas Health Science Center at Tyler Recruiting
Tyler, Texas, United States, 75708
Contact: Julie Philley, MD    903-877-7753    julie.philley@uthct.edu   
Contact: Anne Ford    903-877-7505    Anne.Ford@uthct.edu   
Sponsors and Collaborators
Electromed, Inc.
University of Alabama at Birmingham
Investigators
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Principal Investigator: George Solomon, MD University of Alabama at Birmingham
More Information
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Responsible Party: Electromed, Inc.
ClinicalTrials.gov Identifier: NCT04271969    
Other Study ID Numbers: HFCWO-001
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: March 27, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Electromed, Inc.:
HFCWO
Bronchiectasis
SmartVest
Additional relevant MeSH terms:
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Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases