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

NCT04271969 | Completed FDA Device

• 1 other identifier: HFCWO-001
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 4

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.

Conditions

Bronchiectasis

Keywords

HFCWO; Bronchiectasis; SmartVest

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical Measurements

  1 year

Interventions

SmartVest Airway Clearance System DEVICE

Pulmonary airway clearance of retained mucus via high frequency chest wall oscillation (SmartVest)

Eligibility Criteria

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

Study Population

Primary care clinic

You may qualify if:

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

You may not qualify if:

• Patients who are known to have cystic fibrosis
• Patients who are known to have primary ciliary dyskinesia (PCD)
• Patients with chronic obstructive pulmonary disease (COPD) without bronchiectasis
• Patients breathing via an artificial airway
• Severe bronchospasm based on exam or history
• Any comorbidity(ies) or contraindications that would normally complicate tolerating HFCWO treatment

Sponsors & Collaborators

• Electromed, Inc.: lead
• University of Alabama at Birmingham: collaborator

Study Sites (4)

University of Alabama - Birmingham (UAB University Hospital)

Birmingham, Alabama, 35233-2110, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30342, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

The University of Texas Health Science Center at Tyler

Tyler, Texas, 75708, United States

Location

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Study Officials

• George Solomon, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 17, 2020
• Study Start: February 18, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 7, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)