Status:
COMPLETED
Clinical Effectiveness Of High Frequency Chest Wall Oscillation (HFCWO) In A Bronchiectasis Population
Lead Sponsor:
Electromed, Inc.
Collaborating Sponsors:
University of Alabama at Birmingham
Conditions:
Bronchiectasis
Eligibility:
All Genders
18+ years
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.
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 ...
Eligibility Criteria
Inclusion
- 18 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
Exclusion
- 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
Key Trial Info
Start Date :
February 18 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04271969
Start Date
February 18 2020
End Date
December 1 2023
Last Update
December 7 2023
Active Locations (4)
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1
University of Alabama - Birmingham (UAB University Hospital)
Birmingham, Alabama, United States, 35233-2110
2
Emory University School of Medicine
Atlanta, Georgia, United States, 30342
3
Temple University
Philadelphia, Pennsylvania, United States, 19140
4
The University of Texas Health Science Center at Tyler
Tyler, Texas, United States, 75708