CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 81 enrolled
Drug / intervention
Fenzian Device +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00784758
NCT00784758N/ACompleted

Effect of Fenzian™ Treatment on Symptoms, Pulmonary Function and Albuterol/Salbutamol Use in Patients With Mild to Moderate Persistent Asthma: A Multicenter, Sham-Controlled Clinical Trial

University of California, Los Angeles·interventional·Posted Nov 4, 2008·Updated May 10, 2019

In Brief

A clinical study evaluating Fenzian Device and Sham Device for Asthma. Completed, enrolled 81 participants across 6 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesSouth Africa, United Kingdom, United States
CollaboratorsFenzian Ltd.

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 4, 2008
Enrollment StartFeb 1, 2009
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 17.7 years ago

Interventions

Fenzian Devicedevice

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

Sham Devicedevice

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.)