Clinical trial NCT00784758: Fenzian Asthma Multicenter Outcomes 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Lung Diseases
Respiratory Tract Diseases
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Fenzian Ltd.
First posted: 2008-11-04
Enrollment: 81
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Asthma Control Questionnaire (ACQ) 7 Score
timeFrame: Baseline to completion of treatment at 9 weeks
Secondary outcomes:
measure: Daily Short-acting Bronchodilator (Albuterol/Salbutamol) Use
timeFrame: 2 weeks after completion of treatment (weeks 9-11)
measure: Short-acting Bronchodilator (Albuterol/Salbutamol) Free Days
timeFrame: 2 weeks after completion of treatment (weeks 10 -11)
measure: Change in Asthma Control Questionnaire 6 Score
timeFrame: Baseline to completion of treatment at 9 weeks
measure: Change in Spirometry - FEV1
timeFrame: Baseline to completion of treatment at 9 weeks
measure: Change in Spirometry - Forced Vital Capacity (FVC)
timeFrame: Baseline to completion of treatment at 9 weeks
measure: Change in Spirometry - FEV1/FVC
timeFrame: Baseline to completion of treatment at 9 weeks
measure: Change in Spirometry FEF25-75%
timeFrame: Baseline to completion of treatment at 9 weeks
measure: Change in Asthma Control Test Score
timeFrame: Baseline to completion of treatment at 9 weeks
measure: Change in Mini Asthma Quality of Life Questionnaire (AQLQ) Score (to Evaluate Quality of Life)
timeFrame: Baseline to completion of treatment at 9 weeks
measure: Change in Sino-Nasal Outcome Test (SNOT-22) - Total Score
timeFrame: Baseline to completion of treatment at 9 weeks
measure: Change in SNOT-22 Nasal Sub-score
timeFrame: Baseline to completion of treatment at 9 weeks
measure: Daytime Symptom Score
timeFrame: 7 days prior to final assessment visit at week 15
measure: Change in Transition Dyspnea Index (TDI) - Functional Impairment
timeFrame: Baseline to completion of treatment at 9 weeks
measure: Change in Transition Dyspnea Index - Magnitude of Task at Visit 3
timeFrame: Baseline to completion of treatment at 9 weeks
measure: Change in Transition Dyspnea Index - Magnitude of Effort at Visit 3
timeFrame: Baseline to completion of treatment at 9 weeks
measure: Change in Transition Dyspnea Index - Functional Impairment
timeFrame: Baseline to final assessment visit (15 weeks)
measure: Change in Transition Dyspnea Index - Magnitude of Task
timeFrame: Baseline to final assessment visit (15 weeks)
measure: Change in Transition Dyspnea Index - Magnitude of Effort
timeFrame: Baseline to final assessment visit (15 weeks)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Mowbray
country: South Africa
facility: University of Cape Town Lung Institute
state: Cape Town
city: Bottisham
country: United Kingdom
facility: Addenbrookes NHS Trust, Cambridge University
state: Cambridgeshire
city: London
country: United Kingdom
facility: London Chest Hospital
state: England
Study officials:
affiliation: University of California, Los Angeles
name: Christopher B Cooper, M.D.
role: PRINCIPAL_INVESTIGATOR
References: