Overview

This trial is active, not recruiting.

Condition asthma
Treatments fenzian device, sham device
Sponsor University of California, Los Angeles
Collaborator Fenzian Ltd.
Start date February 2009
End date April 2011
Trial size 125 participants
Trial identifier NCT00784758, Fenzian

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Subjects randomized to this arm will receive treatment with the Fenzian Device
fenzian device
Three 20-minute treatments with the Fenzian Device per week for 5 weeks (for a total of 15 treatments)
(Sham Comparator)
Subjects randomized to this arm will receive treatment with the sham 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.)

Primary Outcomes

Measure
Change in Asthma Control Questionnaire 7 score
time frame: 5 weeks

Secondary Outcomes

Measure
Change in Asthma Control Test score
time frame: 5 weeks
Change in spirometry (FEV1, FVC, FEF25-75%, isovolume FEF25-75%), and daily peak expiratory flow (AM, PM, daily amplitude variability)
time frame: 5 weeks
Change in exhaled nitric oxide (NO) (to evaluate airway inflammation) (at selected sites only)
time frame: 5 weeks
Change in symptoms, use of short-acting bronchodilator and peak expiratory flow
time frame: 5 weeks
Change in Asthma Quality of Life Questionnaire (AQLQ) score (to evaluate Quality of life)
time frame: 5 weeks
Change in Mahler transitional dyspnea index (TDI) score (to evaluate breathlessness)
time frame: 5 weeks

Eligibility Criteria

Male or female participants from 12 years up to 80 years old.

Inclusion Criteria: - Ages 12-80 years. [NOTE: Only the Johns Hopkins site will enroll subjects under 18.] - Clinical history consistent with asthma (GINA 4 definitions) for at least six months - Current symptoms and features of partly-controlled or uncontrolled asthma, according to GINA classification of asthma control - A stable (1 month) treatment regimen consisting of: - as needed short-acting bronchodilators alone, - as needed short-acting bronchodilators in combination with low- or medium-dose inhaled corticosteroids (<= 1000 mcg per day beclomethasone or equivalent, - any combination of long acting beta-agonist bronchodilator and low- or medium-dose inhaled corticosteroid (as defined above),as needed short-acting bronchodilators in combination with montelukast or other leukotriene modifier - Willingness to comply with the study protocol and ability to perform the study procedures. - Willingness to attend the study site according to the specified treatment schedule Inclusion Criteria Assessed at Visit 1: - Pre-bronchodilator FEV1 between 60% predicted and the lower limit of normal. - Pre-bronchodilator FEV1/FVC less than the lower limit of normal. - Reversibility of FEV1 of at least 200 ml, 15-20 minutes after 4 puffs of albuterol HFA pressurized metered-dose inhaler pMDI. Inclusion Criteria Assessed at Visit 2: - Reversibility of FEV1 of at least 200ml, 15-30 minutes after 4 puffs of albuterol HFA pMDI if not confirmed at Visit 1 plus - Using short-acting bronchodilator therapy on two or more occasions in each of the two weeks preceding Visit 2 plus (Ventolin HFA counter decrease of at least 8 puffs) - 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: - Daytime symptoms more than twice per week - Any limitation of activity - Any nocturnal symptoms or awakening - PEF<80% of predicted on any day Exclusion Criteria: - Pulmonary disease other than asthma, such as smoking-related COPD, clinically significant bronchiectasis, lung resection, and interstitial lung disease. - Other significant systemic illness which might, in the opinion of the investigator alter the risk or outcome of the study (e.g. cardiovascular arrhythmias or conduction abnormalities, hyperthyroidism, uncontrolled hypertension, cancer) - Tobacco smoking greater than 10 pack-year of cumulative exposure or current smoking within 10 years. - Respiratory tract infection within 6 weeks of the study. - Seasonal allergies causing symptoms within the past 4 weeks. Perennial or out of season allergic rhinitis is acceptable. Nasal corticosteroids and long-acting antihistamines are acceptable. - Any investigational drug or treatment within 30 days. - Use of cromolyn, nedocromil, theophylline, tiotropium, or oral albuterol within 1 week prior to Visit 1 of the study. - Current use of omalizumab or within the last 8 weeks. - Subjects on anti-depressant (mono-amine oxidase inhibitors or tricyclic antidepressants) treatment within 8 weeks. - Non-potassium sparing diuretics unless in fixed combination with potassium sparing diuretics within one week. - Digoxin, within one week, unless levels have been monitored previously while taking albuterol or LABAs. - Presence of an implanted cardiac pacemaker or neurostimulator. A removable transcutaneous nerve stimulator, not used during the treatment sessions is acceptable. - Non-selective beta agonists. (acceptable choices include: bisproprolol, betaxolol, atenolol, acebutolol and metoprolol) - Subjects who are pregnant or breast feeding. - Persons employed by or related to those employed by the investigative site (e.g. Pulmonary Division). - Prior Fenzian treatment for any indication - Hypersensitivity or intolerance of albuterol HFA pMDI (Ventolin) or its components. Note: if the subject is using ipratropium bromide for rescue short-acting bronchodilator, they must specifically not have been placed on that treatment due to intolerance of albuterol/salbutamol. - Inability to withhold, before and during each visit (except the initial consent visit), xanthine-containing foods (coffee, tea, cola, chocolate, etc.) and alcohol for 6 hours, and short-acting bronchodilators for 8 hours. - Unwillingness to stop use of non-study supplied albuterol (nebulized, CFC or HFA), other short-acting beta agonists (e.g. epinephrine, levalbuterol, metaproterenol, pirbuterol, terbutaline) and ipratropium during the study (after consent through visit 4). - Inability to coordinate the timing for doses of long-acting beta agonists (withhold period at least 12 hours prior to visit) with Visits 1, 2, 3 or 4

Additional Information

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
Principal investigator Christopher B Cooper, M.D.
Description Note regarding the blinding of this study: the subject, investigators, and assessor are all blinded to which treatment arm (Fenzian or sham) the subject is assigned. However, the treatment coordinator, who administers the Fenzian (or sham) treatments, is unblinded. Therefore, the design of this study does not neatly fit into either the "single blind" or the "double blind" category. We would call this study design "subject and observer blinded" because no one involved in any assessment of study outcomes is unblinded. Unfortunately, the clinicaltrials.gov system for posting does not allow us to both indicate "single blind" AND check multiple masked roles. For this reason, this explanation should accompany any discussion of the blinding; subject, investigator, an assessor are all blinded (but cannot be checked).
Trial information was received from ClinicalTrials.gov and was last updated in March 2011.
Information provided to ClinicalTrials.gov by University of California, Los Angeles.