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

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.

Study Overview

• Status: Completed
• Conditions: Bronchiectasis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233-2110
      • University of Alabama - Birmingham (UAB University Hospital)
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Emory University School of Medicine
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University
  • Texas
    • Tyler, Texas, United States, 75708
      • The University of Texas Health Science Center at Tyler

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Primary care clinic

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life (QoL): Quality of Life-Bronchiectasis (QOL-B) questionnaire	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".	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Measurements	Exacerbation ratesa. 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.; Exacerbation frequencyThe time to the subject's next exacerbation will be recorded for comparison pre to post HFCWOLung function (FEV1, FVC, FEF25-75) measured by standard spirometrySputum production measured by using the Breathlessness, Cough and Sputum Scale (BCSS) questionnairePatient adherence to HFCWO treatment measured by SmartVest Connect wireless featureSix-minute walk test measured using American Thoracic Society standard test guidelines/protocolRadiographic changes compare patient's original high-resolution computerized tomography (HRCT) taken to initially	1 year

Collaborators and Investigators

• Sponsor: Electromed, Inc.
• Collaborators: University of Alabama at Birmingham
• Investigators: Principal Investigator: George Solomon, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2020
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: February 13, 2020
• First Submitted That Met QC Criteria: February 14, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Bronchiectasis; HFCWO; SmartVest
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis
• Other Study ID Numbers: HFCWO-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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