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Completed

NCT Number: NCT02423447

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

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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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

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

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 8 years.
  • Known to consistently produce sputum.
  • Currently on a home therapeutic regimen that includes some form of AC performed at least 1 time daily.
  • FEV1 > 30%-predicted, and with stable lung function

Exclusion criteria

  • Hospitalization for CF pulmonary complications in the 1 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 Intervention

Device

An assigned respiratory therapist performed airway clearance on each participant with the Electro-Flo device following the 2012 CFF therapy guidelines

G5 Intervention

Device

An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines

Primary outcomes

  1. Wet Sputum Weight

    Time frame: 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.

  2. Dry Sputum Weight

    Time frame: 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.

  3. Pulmonary Function Measured as a Percent Predicted AFTER Therapy With Either ElectroFlo 5000 / G5.

    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.

Secondary outcomes

  1. Pulmonary Function Measured as a Percent Predicted BEFORE Therapy With Either ElectroFlo 5000 / G5.

    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.

  2. PRO (Patient-reported Outcome)

    Time frame: End of study visit per intervention

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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 22, 2015
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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