Electro Flo 5000 and Vest Therapy (EF/Vest)

• ClinicalTrials.gov Identifier: NCT02277626
• Recruitment Status: Completed
• First Posted: October 29, 2014
• 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 VEST therapy) 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 5000; Device: Incourage Vest System	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparison of the Airway Clearance Efficacy of Electro Flo 5000 and Vest Therapy in
• Study Start Date: April 2012
• Actual Primary Completion Date: April 2013
• Actual Study Completion Date: April 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: Randomized Crossover to ElectroFlo; Experimental: ElectroFlo 5000, then VEST Patients are randomized to a sequence of ElectroFlo 5000 on one visit and during the second visit, they cross-over to the Vest system.	Device: Electro Flo 5000; Airway clearance device
Experimental: Randomized Crossover to Vest; Experimental: VEST, then ElectroFlo 5000 Patients are randomized to a sequence of Vest system on one visit and during the second visit, they cross-over to the ElectroFlo 5000.	Device: Incourage Vest System; Airway Clearance Device

Outcome Measures

Primary Outcome Measures :

1. Wet Sputum Weight [ Time Frame: End of study visit per intervention ]
   Sputum was collected in pre-measured cups in a blinded fashion
2. Pulmonary Function Measured as a Percent Predicted BEFORE Therapy With Either ElectroFlo 5000 / VEST. [ 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.
3. Pulmonary Function Measured as a Percent Predicted AFTER Therapy With Either ElectroFlo 5000 / Vest. [ 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.
4. Comfort Level After Receiving Therapy With Either ElectroFlo 5000 / Vest [ Time Frame: End of study visit per intervention ]
   Comfort assessed on a scale of 1-10 by patients after therapy after each visit (1 being most comfortable, 10 being most un-comfortable)

Secondary Outcome Measures :

1. Dry Sputum Weight [ Time Frame: End of study visit per intervention ]
   Sputum was collected in pre-measured cups in a blinded fashion, dessicated and measured dry

Eligibility Criteria

• Ages Eligible for Study: 12 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 12 years.
3. Known to consistently produce sputum.
4. Currently on a home therapeutic regimen that includes some form of AC performed at least 2 times daily.
5. FVC and FEV1 > 40%-predicted, and with stable lung function (no greater than a 10% variation in lung function parameters over the preceding 3 months).

Exclusion Criteria:

1. Hospitalization for CF pulmonary complications in the 2 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

No Contacts or Locations Provided

More Information

• Responsible Party: Carlos Milla, Principal Investigator, Stanford University
• ClinicalTrials.gov Identifier: NCT02277626
• Other Study ID Numbers: 24248
• First Posted: October 29, 2014
• Results First Posted: January 12, 2016
• Last Update Posted: January 12, 2016
• Last Verified: December 2015

Additional relevant MeSH terms:

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