Fenzian Asthma Multicenter Outcomes Study (FAMOUS)

University of California, Los Angeles (UCLA)

Status

Completed

Conditions

Asthma

Treatments

Device: Sham Device

Device: Fenzian Device

Study type

Interventional

Funder types

Other

Identifiers

NCT00784758

Fenzian

Details and patient eligibility

About

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.

Enrollment

81 patients

Sex

All

Ages

12 to 80 years old

Volunteers

No Healthy Volunteers

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