Back to resultsComparison of the Airway Clearance Efficacy of Electro Flo 5000 and the G5 Flimm-Fighter in Patients With CF
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Electro-Flo Intervention
G5 Intervention
Sponsored by
About this trial
This is an interventional health services research trial for Cystic Fibrosis
Eligibility Criteria
Inclusion Criteria:
- 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).
- Age older than 8 years.
- Known to consistently produce sputum.
- Currently on a home therapeutic regimen that includes some form of AC performed at least 1 time daily.
- FEV1 > 30%-predicted, and with stable lung function
Exclusion Criteria:
- Hospitalization for CF pulmonary complications in the 1 months preceding enrollment.
- Hemoptysis > 60 cc in a single episode in the 4 weeks preceding enrollment.
- Chronic chest pain.
- Participation in another interventional clinical trial in the previous 30 days.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Electro-Flo Arm
G5 Arm
Arm Description
The patients were randomized to a series of airway clearance sessions with Electro-Flo on Day 1 and G5 on Day 2.
The patients were randomized to a series of airway clearance sessions with G5 on Day 1 and Electro-Flo on Day 2.
Outcomes
Primary Outcome Measures
Wet Sputum Weight
To compare the wet to dry weight of study patients' sputum collected during their Day 1 & Day 2 therapy sessions.
Dry Sputum Weight
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.
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 Outcome Measures
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.
PRO (Patient-reported Outcome)
Investigators will question the study patients re: their tolerability and comfort after the intervention on Day 1 & Day 2 visits.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02423447
Brief Title
Comparison of the Airway Clearance Efficacy of Electro Flo 5000 and the G5 Flimm-Fighter in Patients With CF
Official Title
Comparison of the Airway Clearance Efficacy of Electro Flo 5000 and the G5 Flimm-Fighter in Patients With Cystic Fibrosis (CF)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Electro-Flo Arm
Arm Type
Active Comparator
Arm Description
The patients were randomized to a series of airway clearance sessions with Electro-Flo on Day 1 and G5 on Day 2.
Arm Title
G5 Arm
Arm Type
Active Comparator
Arm Description
The patients were randomized to a series of airway clearance sessions with G5 on Day 1 and Electro-Flo on Day 2.
Intervention Type
Device
Intervention Name(s)
Electro-Flo Intervention
Intervention Description
An assigned respiratory therapist performed airway clearance on each participant with the Electro-Flo device following the 2012 CFF therapy guidelines
Intervention Type
Device
Intervention Name(s)
G5 Intervention
Intervention Description
An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines
Primary Outcome Measure Information:
Title
Wet Sputum Weight
Description
To compare the wet to dry weight of study patients' sputum collected during their Day 1 & Day 2 therapy sessions.
Time Frame
End of study visit per intervention
Title
Dry Sputum Weight
Description
To compare the wet to dry weight of study patients' sputum collected during their Day 1 & Day 2 therapy sessions.
Time Frame
End of study visit per intervention
Title
Pulmonary Function Measured as a Percent Predicted AFTER Therapy With Either ElectroFlo 5000 / G5.
Description
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.
Time Frame
End of study visit per intervention
Secondary Outcome Measure Information:
Title
Pulmonary Function Measured as a Percent Predicted BEFORE Therapy With Either ElectroFlo 5000 / G5.
Description
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.
Time Frame
End of study visit per intervention
Title
PRO (Patient-reported Outcome)
Description
Investigators will question the study patients re: their tolerability and comfort after the intervention on Day 1 & Day 2 visits.
Time Frame
End of study visit per intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Age older than 8 years.
Known to consistently produce sputum.
Currently on a home therapeutic regimen that includes some form of AC performed at least 1 time daily.
FEV1 > 30%-predicted, and with stable lung function
Exclusion Criteria:
Hospitalization for CF pulmonary complications in the 1 months preceding enrollment.
Hemoptysis > 60 cc in a single episode in the 4 weeks preceding enrollment.
Chronic chest pain.
Participation in another interventional clinical trial in the previous 30 days.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Milla, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Comparison of the Airway Clearance Efficacy of Electro Flo 5000 and the G5 Flimm-Fighter in Patients With CF
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