Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
University of California, Los Angeles Eumedic Ltd. |
---|---|
Information provided by: | University of California, Los Angeles |
ClinicalTrials.gov Identifier: | NCT00784758 |
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.
Condition | Intervention |
---|---|
Asthma |
Device: Fenzian Device Device: Sham Device |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 125 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | February 2011 |
Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Fenzian Device: Experimental
Subjects randomized to this arm will receive treatment with the Fenzian Device
|
Device: Fenzian Device
Three 20-minute treatments with the Fenzian Device per week for 5 weeks (for a total of 15 treatments)
|
Sham Device: Sham Comparator
Subjects randomized to this arm will receive treatment with the sham device.
|
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.)
|
Ages Eligible for Study: | 12 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A stable (1 month) treatment regimen consisting of:
Inclusion Criteria Assessed at Visit 1:
Inclusion Criteria Assessed at Visit 2:
Partly controlled or uncontrolled of asthma as indicated by one to three, but not four of the following in each of the two weeks preceding Visit 2:
Exclusion Criteria:
United States, California | |
University of California, Los Angeles | |
Los Angeles, California, United States, 90095 | |
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21205 | |
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 | |
South Africa, Cape Town | |
University of Cape Town Lung Institute | |
Mowbray, Cape Town, South Africa, 7700 | |
United Kingdom, Cambridgeshire | |
Addenbrookes NHS Trust, Cambridge University | |
Bottisham, Cambridgeshire, United Kingdom, CB2 OQQ | |
United Kingdom, England | |
London Chest Hospital | |
London, England, United Kingdom |
Principal Investigator: | Christopher B Cooper, M.D. | University of California, Los Angeles |
Responsible Party: | UCLA ( Christopher B. Cooper, M.D. ) |
Study ID Numbers: | Fenzian |
Study First Received: | November 3, 2008 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00784758 |
Health Authority: | United States: Institutional Review Board; South Africa: Medicines Control Council; United Kingdom: Research Ethics Committee |
Asthma Lung Diseases Respiratory Tract Diseases |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases |
Albuterol Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |
Immune System Diseases Bronchial Diseases |