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

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Device: G5 Intervention; Device: Electro-Flo Intervention

• Registration Number: NCT02423447
• Lead Sponsor: Stanford University

Brief 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 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

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.

Study Timeline

• Study Start: 2013-11
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Study First Submitted: 2015-02-03
• Study First Submitted QC: 2015-04-21
• Study First Posted: 2015-04-22
• Results First Submitted: 2015-08-13
• Status Verified: 2015-12
• Results First Submitted QC: 2015-12-07
• Last Update Submitted: 2015-12-07
• Results First Posted: 2016-01-12
• Last Update Posted: 2016-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. 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).
2. Age older than 8 years.
3. Known to consistently produce sputum.
4. Currently on a home therapeutic regimen that includes some form of AC performed at least 1 time daily.
5. FEV1 > 30%-predicted, and with stable lung function

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Exclusion Criteria

1. Hospitalization for CF pulmonary complications in the 1 months preceding enrollment.
2. Hemoptysis > 60 cc in a single episode in the 4 weeks preceding enrollment.
3. Chronic chest pain.
4. Participation in another interventional clinical trial in the previous 30 days.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
G5 Arm	G5 Intervention	The patients were randomized to a series of airway clearance sessions with G5 on Day 1 and Electro-Flo on Day 2.
Electro-Flo Arm	Electro-Flo Intervention	The patients were randomized to a series of airway clearance sessions with Electro-Flo on Day 1 and G5 on Day 2.

Primary Outcome Measures

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

Secondary Outcome Measures

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