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.
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
- Are there results?
- None posted in the registry
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
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
- Exacerbation rates
- 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- 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)
Sponsor and investigators
- Lead sponsor
- Electromed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Alabama at Birmingham
- Responsible party
- Sponsor
- Investigators
- George Solomon, MD, Principal investigator, University of Alabama at Birmingham
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness Of High Frequency Chest Wall Oscillation (HFCWO) In A Bronchiectasis Population
- ClinicalTrials.gov ID
- NCT04271969
- Acronym / sponsor ID
- HFCWO / HFCWO-001
- Conditions
- Bronchiectasis
- Keywords
- HFCWO, Bronchiectasis, SmartVest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Electromed, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Alabama at Birmingham
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmartVest Airway Clearance SystemPulmonary airway clearance of retained mucus via high frequency chest wall oscillation (SmartVest) | Device | – |
Primary outcome
Quality of Life (QoL): Quality of Life-Bronchiectasis (QOL-B) questionnaire
Time frame: 1 year
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 secondary outcome
Clinical Measurements
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: No
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Bronchiectasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Solomon, MD principal investigator
University of Alabama at Birmingham
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiectasis, run by Electromed, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (QoL): Quality of Life-Bronchiectasis (QOL-B) questionnaire (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.