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

NCT ID: NCT02423447

Last Updated: 2016-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-06-30

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.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Electro-Flo Intervention

Intervention Type: DEVICE

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

G5 Arm

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

Group Type: ACTIVE_COMPARATOR

G5 Intervention

Intervention Type: DEVICE

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

Interventions

Electro-Flo Intervention

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

Intervention Type: DEVICE

G5 Intervention

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Carlos Milla

Associate Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlos Milla, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Other Identifiers

27689

Identifier Type: -

Identifier Source: org_study_id