Electro Flo 5000 and Vest Therapy

Cystic Fibrosis Clinical Trial

— EF/Vest  

Official title:

Comparison of the Airway Clearance Efficacy of Electro Flo 5000 and Vest Therapy in

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02277626
• Other study ID #: 24248
• Status: Completed
• Phase: Phase 4
• First received: October 27, 2014
• Last updated: December 7, 2015
• Start date: April 2012
• Est. completion date: April 2013

Study information

• Verified date: December 2015
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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. -

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis

Intervention

Device:
• Electro Flo 5000
Airway clearance device
• Incourage Vest System
Airway Clearance Device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wet Sputum Weight	Sputum was collected in pre-measured cups in a blinded fashion	End of study visit per intervention	No
Primary	Pulmonary Function Measured as a Percent Predicted BEFORE Therapy With Either ElectroFlo 5000 / VEST.	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	No
Primary	Pulmonary Function Measured as a Percent Predicted AFTER Therapy With Either ElectroFlo 5000 / Vest.	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	No
Primary	Comfort Level After Receiving Therapy With Either ElectroFlo 5000 / Vest	Comfort assessed on a scale of 1-10 by patients after therapy after each visit (1 being most comfortable, 10 being most un-comfortable)	End of study visit per intervention	No
Secondary	Dry Sputum Weight	Sputum was collected in pre-measured cups in a blinded fashion, dessicated and measured dry	End of study visit per intervention	No