Electro Flo 5000 and Vest Therapy

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of the Airway Clearance Efficacy of Electro Flo 5000 and Vest Therapy in

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Device: Electro Flo 5000
* Device: Incourage Vest System


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Randomized Crossover to ElectroFlo<br>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. | Device: Electro Flo 5000<br>* Airway clearance device<br>|
| Experimental: Randomized Crossover to Vest<br>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. | Device: Incourage Vest System<br>* Airway Clearance Device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wet Sputum Weight | Sputum was collected in pre-measured cups in a blinded fashion | 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. | 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. | 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) | End of study visit per intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dry Sputum Weight | Sputum was collected in pre-measured cups in a blinded fashion, dessicated and measured dry | End of study visit per intervention |