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Fenzian Asthma Multicenter Outcomes Study

NCT00784758 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2019-05-10

Study results available
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Summary

The purpose of this study is to investigate the effects of Fenzian™ treatment on symptoms (such as shortness of breath), lung function (how well the lungs work), and albuterol/salbutamol (rescue medication) use in people with asthma. This will be done by comparing the effects of Fenzian™ treatment to the effects of a sham treatment, which looks the same as the Fenzian™ device but doesn't do anything.

The Fenzian™ device is an electrical instrument that the investigators hope will help reduce airway inflammation associated with asthma symptoms by stimulating the nerves with very low electrical currents. The study device will be applied directly to the skin on the back, working along the ribs toward the spine, alternating between left and right sides, and on your face.

Conditions

Interventions

DEVICE

Fenzian Device

Three 20-minute treatments with the Fenzian Device per week for 5 weeks (for a total of 15 treatments)

DEVICE

Sham Device

Three 20-minute treatments with the sham device per week for 5 weeks (for a total of 15 treatments) (NOTE: This arm is similar to a placebo arm in a drug trial.)

Sponsors & Collaborators

Principal Investigators

  • Christopher B Cooper, M.D. · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United States
  • South Africa
  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00784758 on ClinicalTrials.gov