BronchiectasisHFCWONCT04271969

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

An observational study of Bronchiectasis, run by Electromed, Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Bronchiectasis
What is being tested?: SmartVest Airway Clearance System
Type of treatment: Medical device
How many people: 25 participants
Where: 4 sitesUnited States
Study dates: 18 Feb 2020to 1 Dec 2023
Phase: Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Primary care clinic

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

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

Other trials in United States

About this study

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.

Read the 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.

Conditions: Bronchiectasis
Being tested: SmartVest Airway Clearance System
Keywords: HFCWO, Bronchiectasis, SmartVest
Medical subject headings: Bronchiectasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

What is being measured

The primary outcome is the main question the study is designed to answer.

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".
Measured: 1 year

Secondary outcomes (1)

Clinical Measurements
1. Exacerbation rates
2. 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.
3. Exacerbation frequency
4. The time to the subject's next exacerbation will be recorded for comparison pre to post HFCWO
5. Lung function (FEV1, FVC, FEF25-75) measured by standard spirometry
6. Sputum production measured by using the Breathlessness, Cough and Sputum Scale (BCSS) questionnaire
7. Patient adherence to HFCWO treatment measured by SmartVest Connect wireless feature
8. Six-minute walk test measured using American Thoracic Society standard test guidelines/protocol
9. Radiographic changes compare patient's original high-resolution computerized tomography (HRCT) taken to initially
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Feb 20201 Dec 2023

First posted17 Feb 2020
Study start18 Feb 2020
Primary completion1 Dec 2023
Study completion1 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for BronchiectasisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04271969
Sponsor's protocol ID: HFCWO-001
Acronym: HFCWO
Status last verified: Dec 2023
First submitted: 13 Feb 2020
Last updated: 7 Dec 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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