Phase 4
N=15
Electro Flo 5000 and Vest Therapy
Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT02277626 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcome: Primary: Wet Sputum Weight — 3.8; 4.6 grams
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Electro Flo 5000 (Device); Incourage Vest System (Device)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wet Sputum Weight |
3.8; 4.6 | — |
| PRIMARY Pulmonary Function Measured as a Percent Predicted BEFORE Therapy With Either ElectroFlo 5000 / VEST. |
72.43; 72.93 | — |
| PRIMARY Pulmonary Function Measured as a Percent Predicted AFTER Therapy With Either ElectroFlo 5000 / Vest. |
75.8; 75.73 | — |
| PRIMARY Comfort Level After Receiving Therapy With Either ElectroFlo 5000 / Vest |
3.93; 2.67 | — |
| SECONDARY Dry Sputum Weight |
0.15; 0.18 | — |
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 routine therapeutic regimen.
Eligibility Criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- 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. -
Data sourced from ClinicalTrials.gov (NCT02277626). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.