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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electro-Flo Arm | Active Comparator | The patients were randomized to a series of airway clearance sessions with Electro-Flo on Day 1 and G5 on Day 2. |
|
| G5 Arm | Active Comparator | The patients were randomized to a series of airway clearance sessions with G5 on Day 1 and Electro-Flo on Day 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electro-Flo Intervention | Device | An assigned respiratory therapist performed airway clearance on each participant with the Electro-Flo device following the 2012 CFF therapy guidelines |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Milla, MD | Stanford University | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants had the diagnosis of cystic fibrosis. All enrolled had baseline sputum production and were deemed at their baseline health status.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Wet Sputum Weight | To compare the wet to dry weight of study patients' sputum collected during their Day 1 & Day 2 therapy sessions. | Posted | Mean | Full Range | gram | End of study visit per intervention |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Electro Flo | Electro flo |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carlos Milla, MD | Stanford University | 650-723-5193 | cmilla@stanford.edu |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| G5 Intervention | Device | An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines |
|
| 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 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Basline Pulmonary Function (FEV1) | Mean | Standard Deviation | Liters |
|
|
|
| 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. | Posted | Mean | Full Range | percentage of predicted value | End of study visit per intervention |
|
|
|
| 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. | Patients rated comfort on a scale of 1 (most comfortable) to 10 (most un-comfortable) | Posted | Mean | Full Range | units on a scale | End of study visit per intervention |
|
|
|
| Primary | Dry Sputum Weight | To compare the wet to dry weight of study patients' sputum collected during their Day 1 & Day 2 therapy sessions. | Posted | Mean | Full Range | gram | End of study visit per intervention |
|
|
|
| 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. | Posted | Mean | Full Range | percentage of predicted value | End of study visit per intervention |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | G5 Flimm Fighter | G5 Flimm Fighter | 0 | 25 | 0 | 25 |
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |