Fenzian Asthma Multicenter Outcomes Study
Fenzian Asthma Multicenter Outcomes Study
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.
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 forced expiratory volume at one second (FEV1) between 60% predicted
 and the lower limit of normal.

 -  Pre-bronchodilator [FEV1/forced vital capacity (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
 pressurized metered-dose inhaler (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

 -  peak expiratory flow (PEF)<80% of predicted on any day

 Exclusion Criteria:

 -  Pulmonary disease other than asthma, such as smoking-related chronic obstructive
 pulmonary disease (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 long-acting beta2-agonist (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: bisprolol, 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,
 chlorofluorocarbon (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