Cystic FibrosisPhase 4EF/VestNCT02277626
Electro Flo 5000 and Vest Therapy
A Phase 4 study testing Electro Flo 5000 and Incourage Vest System in people with Cystic Fibrosis, run by Stanford University.
Trial summary
It is the goal of the proposed study to compare the efficacy, as assessed primarily by sputum weight, of these two different devices (the Electroflo 500 and VEST therapy) for airway clearance (AC) in CF patients with mild to moderate lung disease, who have stable lung health and perform AC at home as part of their… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Electro Flo 5000 and Incourage Vest System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to Apr 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of CF established by standard criteria (sweat chloride > 60 mmol/L and/or two alleles affected by gene mutations know to be associated with CF).
- Age older than 12 years.
- Known to consistently produce sputum.
- Currently on a home therapeutic regimen that includes some form of AC performed at least 2 times daily.
- FVC and FEV1 > 40%-predicted, and with stable lung function (no greater than a 10% variation in lung function parameters over the preceding 3 months).
Who cannot join
- Hospitalization for CF pulmonary complications in the 2 months preceding enrollment.
- Hemoptysis > 60 cc in a single episode in the 4 weeks preceding enrollment.
- Chronic chest pain.
- Participation in another interventional clinical trial in the previous 30 days. -
About this study
Official title: Comparison of the Airway Clearance Efficacy of Electro Flo 5000 and Vest Therapy in
It is the goal of the proposed study to compare the efficacy, as assessed primarily by sputum weight, of these two different devices (the Electroflo 500 and VEST therapy) for airway clearance (AC) in CF patients with mild to moderate lung disease, who have stable lung health and perform AC at home as part of their routine therapeutic regimen.
- Conditions
- Cystic Fibrosis
- Being tested
- Electro Flo 5000, Incourage Vest System
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electro Flo 5000Device
Airway clearance device
Incourage Vest SystemDevice
Airway Clearance Device
| Study group | Role | What they receive |
|---|---|---|
| Randomized Crossover to ElectroFlo | Experimental | Experimental: ElectroFlo 5000, then VEST Patients are randomized to a sequence of ElectroFlo 5000 on one visit and during the second visit, they cross-over to the Vest system. Receives: Device: Electro Flo 5000 |
| Randomized Crossover to Vest | Experimental | Experimental: VEST, then ElectroFlo 5000 Patients are randomized to a sequence of Vest system on one visit and during the second visit, they cross-over to the ElectroFlo 5000. Receives: Device: Incourage Vest System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wet Sputum Weight
Sputum was collected in pre-measured cups in a blinded fashion
Measured: End of study visit per intervention
Pulmonary Function Measured as a Percent Predicted BEFORE Therapy With Either ElectroFlo 5000 / VEST.
Comparison of pulmonary function by doing spirometry testing on study patients during their Day 1 \& Day 2 therapy sessions. Will also compare the results based on the therapies they receive.
Measured: End of study visit per intervention
Pulmonary Function Measured as a Percent Predicted AFTER Therapy With Either ElectroFlo 5000 / Vest.
Comparison of pulmonary function by doing spirometry testing on study patients during their Day 1 \& Day 2 therapy sessions. Will also compare the results based on the therapies they receive.
Measured: End of study visit per intervention
Comfort Level After Receiving Therapy With Either ElectroFlo 5000 / Vest
Comfort assessed on a scale of 1-10 by patients after therapy after each visit (1 being most comfortable, 10 being most un-comfortable)
Measured: End of study visit per intervention
Secondary outcomes (1)
Dry Sputum Weight
Sputum was collected in pre-measured cups in a blinded fashion, dessicated and measured dry
Measured: End of study visit per intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study startApr 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Milla, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02277626
- Sponsor's protocol ID
- 24248
- Acronym
- EF/Vest
- Status last verified
- Dec 2015
- First submitted
- 27 Oct 2014
- Last updated
- 12 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Airway Clearance Efficacy of Electro Flo 5000 and Vest Therapy in
- ClinicalTrials.gov ID
- NCT02277626
- Acronym / sponsor ID
- EF/Vest / 24248
- Conditions
- Cystic Fibrosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 29 Oct 2014 (estimated)
- Results
- Posted 12 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is the goal of the proposed study to compare the efficacy, as assessed primarily by sputum weight, of these two different devices (the Electroflo 500 and VEST therapy) for airway clearance (AC) in CF patients with mild to moderate lung disease, who have stable lung health and perform AC at home as part of their routine therapeutic regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Randomized Crossover to ElectroFlo | Experimental | Device: Electro Flo 5000Experimental: ElectroFlo 5000, then VEST Patients are randomized to a sequence of ElectroFlo 5000 on one visit and during the second visit, they cross-over to the Vest system. |
| Randomized Crossover to Vest | Experimental | Device: Incourage Vest SystemExperimental: VEST, then ElectroFlo 5000 Patients are randomized to a sequence of Vest system on one visit and during the second visit, they cross-over to the ElectroFlo 5000. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of CF established by standard criteria (sweat chloride > 60 mmol/L and/or two alleles affected by gene mutations know to be associated with CF).
- Age older than 12 years.
- Known to consistently produce sputum.
- Currently on a home therapeutic regimen that includes some form of AC performed at least 2 times daily.
- FVC and FEV1 > 40%-predicted, and with stable lung function (no greater than a 10% variation in lung function parameters over the preceding 3 months).
Key exclusion criteria (4 listed)
- Hospitalization for CF pulmonary complications in the 2 months preceding enrollment.
- Hemoptysis > 60 cc in a single episode in the 4 weeks preceding enrollment.
- Chronic chest pain.
- Participation in another interventional clinical trial in the previous 30 days. -
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 |
|---|---|---|
| Electro Flo 5000Airway clearance device | Device | Randomized Crossover to ElectroFlo |
| Incourage Vest SystemAirway Clearance Device | Device | Randomized Crossover to Vest |
Primary outcome
Wet Sputum Weight
Time frame: End of study visit per intervention
Sputum was collected in pre-measured cups in a blinded fashion
Pulmonary Function Measured as a Percent Predicted BEFORE Therapy With Either ElectroFlo 5000 / VEST.
Time frame: End of study visit per intervention
Comparison of pulmonary function by doing spirometry testing on study patients during their Day 1 \& Day 2 therapy sessions. Will also compare the results based on the therapies they receive.
Pulmonary Function Measured as a Percent Predicted AFTER Therapy With Either ElectroFlo 5000 / Vest.
Time frame: End of study visit per intervention
Comparison of pulmonary function by doing spirometry testing on study patients during their Day 1 \& Day 2 therapy sessions. Will also compare the results based on the therapies they receive.
Comfort Level After Receiving Therapy With Either ElectroFlo 5000 / Vest
Time frame: End of study visit per intervention
Comfort assessed on a scale of 1-10 by patients after therapy after each visit (1 being most comfortable, 10 being most un-comfortable)
1 secondary outcome
Dry Sputum Weight
Time frame: End of study visit per intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Electro Flo 5000 and Incourage Vest System in people with Cystic Fibrosis, run by Stanford University.
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 5 inclusion and 4 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 12 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Wet Sputum Weight (time frame: End of study visit per intervention). The study lists 4 primary outcomes in all. 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 12 Jan 2016.