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

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

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 Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Device: Electro-Flo Intervention; Device: G5 Intervention

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Electro-Flo Arm; 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; An assigned respiratory therapist performed airway clearance on each participant with the Electro-Flo device following the 2012 CFF therapy guidelines
Active Comparator: G5 Arm; 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; An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: February 3, 2015
• First Submitted That Met QC Criteria: April 21, 2015
• First Posted (Estimate): April 22, 2015

Study Record Updates

• Last Update Posted (Estimate): January 12, 2016
• Last Update Submitted That Met QC Criteria: December 7, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: 27689