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

Stanford University

Status: Completed

Conditions: Cystic Fibrosis

Treatments: Device: Electro-Flo Intervention; Device: G5 Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02423447

27689

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 8+ years old

Volunteers: No 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Electro-Flo Arm

Active Comparator group

Description:

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

Treatment:

Device: Electro-Flo Intervention

G5 Arm

Active Comparator group

Description:

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

Treatment:

Device: G5 Intervention