Clinical trial NCT04271969: Clinical Effectiveness Of High Frequency Chest Wall Oscillation (HFCWO) In A Bronchiectasis Population
Official title: Clinical Effectiveness Of High Frequency Chest Wall Oscillation (HFCWO) In A Bronchiectasis Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchiectasis
Keywords: HFCWO
Bronchiectasis
SmartVest
Lead sponsor: Electromed, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Alabama at Birmingham
First posted: 2020-02-17
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

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 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.

Eligibility 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

Primary outcomes:
measure: Quality of Life (QoL): Quality of Life-Bronchiectasis (QOL-B) questionnaire
timeFrame: 1 year
Secondary outcomes:
measure: Clinical Measurements
timeFrame: 1 year
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama - Birmingham (UAB University Hospital)
state: Alabama
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Tyler
country: United States
facility: The University of Texas Health Science Center at Tyler
state: Texas
Study officials:
affiliation: University of Alabama at Birmingham
name: George Solomon, MD
role: PRINCIPAL_INVESTIGATOR
References: