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Completed

NCT Number: NCT02277626

Electro Flo 5000 and Vest Therapy

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).
  • Age older than 12 years.
  • Known to consistently produce sputum.
  • Currently on a home therapeutic regimen that includes some form of AC performed at least 2 times daily.
  • 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

  • Hospitalization for CF pulmonary complications in the 2 months preceding enrollment.
  • Hemoptysis > 60 cc in a single episode in the 4 weeks preceding enrollment.
  • Chronic chest pain.
  • Participation in another interventional clinical trial in the previous 30 days. -

Treatment and study plan

Electro Flo 5000

Device

Airway clearance device

Incourage Vest System

Device

Airway Clearance Device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Acronym: EF/Vest

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 29, 2014
Registry last updated
Jan 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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