Electro Flo 5000 and Vest Therapy

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02277626

Acronym

EF/Vest

Enrollment

Registered

2014-10-29

Start date

2012-04-30

Completion date

2013-04-30

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 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.

Interventions

DEVICEElectro Flo 5000

Airway clearance device

DEVICEIncourage Vest System

Airway Clearance Device

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 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 12 years. 3. Known to consistently produce sputum. 4. Currently on a home therapeutic regimen that includes some form of AC performed at least 2 times daily. 5. 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

1. Hospitalization for CF pulmonary complications in the 2 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	Sputum was collected in pre-measured cups in a blinded fashion
Pulmonary Function Measured as a Percent Predicted BEFORE Therapy With Either ElectroFlo 5000 / VEST.	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.
Pulmonary Function Measured as a Percent Predicted AFTER Therapy With Either ElectroFlo 5000 / Vest.	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.
Comfort Level After Receiving Therapy With Either ElectroFlo 5000 / Vest	End of study visit per intervention	Comfort assessed on a scale of 1-10 by patients after therapy after each visit (1 being most comfortable, 10 being most un-comfortable)

Secondary

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

Participant flow

Participants by arm

Arm	Count
Total Number of Participants	15
Total	15

Baseline characteristics

Characteristic	Total Number of Participants
Age, Continuous	33.33 years
Sex: Female, Male Female	8 Participants
Sex: Female, Male Male	7 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 15	0 / 15
serious Total, serious adverse events	0 / 15	0 / 15

Outcome results

Primary

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)