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)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02423447

Enrollment

Registered

2015-04-22

Start date

2013-11-30

Completion date

2014-06-30

Last updated

2016-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

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.

Interventions

DEVICEElectro-Flo Intervention

An assigned respiratory therapist performed airway clearance on each participant with the Electro-Flo device following the 2012 CFF therapy guidelines

DEVICEG5 Intervention

An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

8 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.

Participant flow

Participants by arm

Arm	Count
All Study Participants Electro-Flo Intervention: An assigned respiratory therapist performed airway clearance on each participant with the Electro-Flo device following the 2012 CFF therapy guidelines. G5 Intervention: An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines.	25
Total	25

Baseline characteristics

Characteristic	All Study Participants
Age, Categorical <=18 years	5 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	20 Participants
Basline Pulmonary Function (FEV1)	2.42 Liters STANDARD_DEVIATION 20.28
Sex: Female, Male Female	19 Participants
Sex: Female, Male Male	6 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 25	0 / 25
serious Total, serious adverse events	0 / 25	0 / 25

Outcome results

Primary

Dry Sputum Weight

To compare the wet to dry weight of study patients' sputum collected during their Day 1 & Day 2 therapy sessions.