Trial Outcomes & Findings for Comparison of the Airway Clearance Efficacy of Electro Flo 5000 and the G5 Flimm-Fighter in Patients With CF (NCT NCT02423447)

NCT ID: NCT02423447

Last Updated: 2016-01-12

Results Overview

To compare the wet to dry weight of study patients' sputum collected during their Day 1 \& Day 2 therapy sessions.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 25 participants
• Primary outcome timeframe: End of study visit per intervention
• Results posted on: 2016-01-12

Participant Flow

Participant milestones

Measure	Electro-Flo, Then G5 The patients were randomized to a series of airway clearance sessions with Electro-Flo on Day 1 and G5 on Day 2. 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, Then Electro-Flo The patients were randomized to a series of airway clearance sessions with G5 on Day 1 and Electro-Flo on Day 2. G5 Intervention: An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines
Overall Study STARTED	13	12
Overall Study COMPLETED	13	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	All Study Participants n=25 Participants 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.
Age, Categorical <=18 years	5 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Basline Pulmonary Function (FEV1)	2.42 Liters STANDARD_DEVIATION 20.28 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	ElectroFlo Arm n=25 Participants ElectroFlo Arm	G5 Flimm Fighter Arm n=25 Participants G5 Flimm Fighter arm
Wet Sputum Weight	5.22 gram Interval 0.0 to 11.2	4.19 gram Interval 0.0 to 8.56

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	ElectroFlo Arm n=25 Participants ElectroFlo Arm	G5 Flimm Fighter Arm n=25 Participants G5 Flimm Fighter arm
Dry Sputum Weight	0.21 gram Interval 0.0 to 0.54	0.15 gram Interval 0.0 to 0.33

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	ElectroFlo Arm n=25 Participants ElectroFlo Arm	G5 Flimm Fighter Arm n=25 Participants G5 Flimm Fighter arm
Pulmonary Function Measured as a Percent Predicted AFTER Therapy With Either ElectroFlo 5000 / G5.	71.36 percentage of predicted value Interval 51.08 to 91.64	71.52 percentage of predicted value Interval 51.45 to 91.59

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	ElectroFlo Arm n=25 Participants ElectroFlo Arm	G5 Flimm Fighter Arm n=25 Participants G5 Flimm Fighter arm
Pulmonary Function Measured as a Percent Predicted BEFORE Therapy With Either ElectroFlo 5000 / G5.	69.16 percentage of predicted value Interval 49.25 to 89.07	69.84 percentage of predicted value Interval 49.61 to 90.07

SECONDARY outcome

Timeframe: End of study visit per intervention

Population: Patients rated comfort on a scale of 1 (most comfortable) to 10 (most un-comfortable)

Investigators will question the study patients re: their tolerability and comfort after the intervention on Day 1 & Day 2 visits.

Outcome measures

Measure	ElectroFlo Arm n=25 Participants ElectroFlo Arm	G5 Flimm Fighter Arm n=25 Participants G5 Flimm Fighter arm
PRO (Patient-reported Outcome)	3.24 units on a scale Interval 1.03 to 5.45	3.2 units on a scale Interval 0.58 to 5.82

Adverse Events

Electro Flo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

G5 Flimm Fighter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Carlos Milla, MD

Stanford University

Phone: 650-723-5193

Email: cmilla@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place