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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02423447
• Other study ID #: 27689
• Status: Completed
• Phase: N/A
• First received: February 3, 2015
• Last updated: December 7, 2015
• Start date: November 2013
• Est. completion date: June 2014

Study information

• Verified date: December 2015
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No