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

• ClinicalTrials.gov Identifier: NCT02423447
• Recruitment Status: Completed
• First Posted: April 22, 2015
• Results First Posted: January 12, 2016
• Last Update Posted: January 12, 2016
• Sponsor: Stanford University
• Information provided by (Responsible Party): Carlos Milla, Stanford University

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.

Condition or disease	Intervention/treatment	Phase
Cystic Fibrosis	Device: Electro-Flo Intervention; Device: G5 Intervention	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Comparison of the Airway Clearance Efficacy of Electro Flo 5000 and the G5 Flimm-Fighter in Patients With Cystic Fibrosis (CF)
• Study Start Date: November 2013
• Actual Primary Completion Date: June 2014
• Actual Study Completion Date: June 2014

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	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
Active Comparator: G5 Arm; The patients were randomized to a series of airway clearance sessions with G5 on Day 1 and Electro-Flo on Day 2.	Device: G5 Intervention; An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines

Outcome Measures

Primary Outcome Measures :

1. Wet Sputum Weight [ Time Frame: End of study visit per intervention ]
   To compare the wet to dry weight of study patients' sputum collected during their Day 1 & Day 2 therapy sessions.
2. Dry Sputum Weight [ Time Frame: End of study visit per intervention ]
   To compare the wet to dry weight of study patients' sputum collected during their Day 1 & Day 2 therapy sessions.
3. Pulmonary Function Measured as a Percent Predicted AFTER Therapy With Either ElectroFlo 5000 / G5. [ Time Frame: 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.

Secondary Outcome Measures :

1. Pulmonary Function Measured as a Percent Predicted BEFORE Therapy With Either ElectroFlo 5000 / G5. [ Time Frame: 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.
2. PRO (Patient-reported Outcome) [ Time Frame: End of study visit per intervention ]
   Investigators will question the study patients re: their tolerability and comfort after the intervention on Day 1 & Day 2 visits.

Eligibility Criteria

• Ages Eligible for Study: 8 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Sponsors and Collaborators

Stanford University

Investigators

• Principal Investigator: Carlos Milla, MD; Stanford University

More Information

• Responsible Party: Carlos Milla, Associate Professor of Pediatrics, Stanford University
• ClinicalTrials.gov Identifier: NCT02423447
• Other Study ID Numbers: 27689
• First Posted: April 22, 2015
• Results First Posted: January 12, 2016
• Last Update Posted: January 12, 2016
• Last Verified: December 2015

Additional relevant MeSH terms:

Cystic Fibrosis; Fibrosis; Pathologic Processes; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Infant, Newborn, Diseases