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

NCT02423447 | Completed Results

• 1 other identifier: 27689
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (2)

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

  End of study visit per intervention

• PRO (Patient-reported Outcome)

  End of study visit per intervention

Study Arms (2)

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.

Device: Electro-Flo Intervention

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.

Device: G5 Intervention

Interventions

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

Electro-Flo Arm

G5 Intervention DEVICE

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

G5 Arm

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Carlos Milla, MD
• Organization: Stanford University

cmilla@stanford.edu

650-723-5193

Study Officials

• Carlos Milla, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: February 3, 2015
• First Posted: April 22, 2015
• Study Start: November 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: January 12, 2016
• Results First Posted: January 12, 2016

Record last verified: 2015-12