Comparison of the Airway Clearance Efficacy of Electro Flo 5000 and the G5 Flimm-Fighter in Patients With CF

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 the G5 Flimm-Fighter) 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.

Detailed Description
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The investigators hope to enroll 25 patients with cystic fibrosis (with daily sputum production) in this study. 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 the G5 Flimm-Fighter) 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 the G5 Flimm-Fighter in Patients With Cystic Fibrosis (CF)

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Device: Electro-Flo Intervention
* Device: G5 Intervention


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 8 years. Known to consistently produce sputum. Currently on a home therapeutic regimen that includes some form of AC performed at least 1 time daily. FEV1 > 30%-predicted, and with stable lung function Exclusion Criteria: Hospitalization for CF pulmonary complications in the 1 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: 8 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: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Electro-Flo Arm<br>The patients were randomized to a series of airway clearance sessions with Electro-Flo on Day 1 and G5 on Day 2. | Device: Electro-Flo Intervention<br>* An assigned respiratory therapist performed airway clearance on each participant with the Electro-Flo device following the 2012 CFF therapy guidelines<br>|
| Active Comparator: G5 Arm<br>The patients were randomized to a series of airway clearance sessions with G5 on Day 1 and Electro-Flo on Day 2. | Device: G5 Intervention<br>* An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wet Sputum Weight | To compare the wet to dry weight of study patients' sputum collected during their Day 1 & Day 2 therapy sessions. | End of study visit per intervention | 
| Dry Sputum Weight | To compare the wet to dry weight of study patients' sputum collected during their Day 1 & Day 2 therapy sessions. | End of study visit per intervention | 
| Pulmonary Function Measured as a Percent Predicted AFTER Therapy With Either ElectroFlo 5000 / G5. | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary Function Measured as a Percent Predicted BEFORE Therapy With Either ElectroFlo 5000 / G5. | 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 | 
| PRO (Patient-reported Outcome) | Investigators will question the study patients re: their tolerability and comfort after the intervention on Day 1 & Day 2 visits. | End of study visit per intervention |