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

Bronchiectasis Clinical Trial

— HFCWO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04271969
• Other study ID #: HFCWO-001
• Status: Completed
• Start date: February 18, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: December 2023
• Source: Electromed, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

Device:
• SmartVest Airway Clearance System
Pulmonary airway clearance of retained mucus via high frequency chest wall oscillation (SmartVest)

Locations

Country	Name	City	State
United States	Emory University School of Medicine	Atlanta	Georgia
United States	University of Alabama - Birmingham (UAB University Hospital)	Birmingham	Alabama
United States	Temple University	Philadelphia	Pennsylvania
United States	The University of Texas Health Science Center at Tyler	Tyler	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Electromed, Inc.	University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical Measurements	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.; Exacerbation frequency; The time to the subject's next exacerbation will be recorded for comparison pre to post HFCWO; Lung function (FEV1, FVC, FEF25-75) measured by standard spirometry; Sputum production measured by using the Breathlessness, Cough and Sputum Scale (BCSS) questionnaire; Patient adherence to HFCWO treatment measured by SmartVest Connect wireless feature; Six-minute walk test measured using American Thoracic Society standard test guidelines/protocol; Radiographic changes compare patient's original high-resolution computerized tomography (HRCT) taken to initially	1 year