Fenzian Asthma Multicenter Outcomes Study

NCT00784758 | Completed Results

• 1 other identifier: Fenzian
• Study Type: interventional
• Target: 81
• Locations: 3 countries
• Sites: 6

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.

Conditions

Asthma

Keywords

Asthma; Lung Diseases; Respiratory Tract Diseases

Outcome Measures

Primary Outcomes (1)

• Change in Asthma Control Questionnaire (ACQ) 7 Score

  Asthma Control Questionnaire (QOL Technologies 2004) Elizabeth Juniper, (Eur Respir J 1999; 14:902-7). Range 0-6, 0 is no symptoms, 6 is maximal symptoms. 0.5 is considered a minimally important difference, 0.75 or less is associated with a 85% chance that the subject's asthma is well controlled, 1.50 or greater is associated with a 88% chance that the subject's asthma is not well controlled. The ACQ consists of 6 patient/subject reported questions on symptoms and a question completed by the staff for categorization of the patient/subjects forced expiratory volume in the first second (FEV1) from spirometry.

  Baseline to completion of treatment at 9 weeks

Secondary Outcomes (18)

• Daily Short-acting Bronchodilator (Albuterol/Salbutamol) Use

  2 weeks after completion of treatment (weeks 9-11)

• Short-acting Bronchodilator (Albuterol/Salbutamol) Free Days

  2 weeks after completion of treatment (weeks 10 -11)

• Change in Asthma Control Questionnaire 6 Score

  Baseline to completion of treatment at 9 weeks

• Change in Spirometry - FEV1

  Baseline to completion of treatment at 9 weeks

• Change in Spirometry - Forced Vital Capacity (FVC)

  Baseline to completion of treatment at 9 weeks

Study Arms (2)

Fenzian Device

EXPERIMENTAL

Subjects randomized to this arm will receive treatment with the Fenzian Device

Device: Fenzian Device

Sham Device

SHAM COMPARATOR

Subjects randomized to this arm will receive treatment with the sham device.

Device: Sham Device

Interventions

Fenzian Device DEVICE

Three 20-minute treatments with the Fenzian Device per week for 5 weeks (for a total of 15 treatments)

Fenzian Device

Sham Device 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.)

Sham Device

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• 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:

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Fenzian Ltd.: collaborator

Study Sites (6)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University of Cape Town Lung Institute

Mowbray, Cape Town, 7700, South Africa

Location

Addenbrookes NHS Trust, Cambridge University

Bottisham, Cambridgeshire, CB2 OQQ, United Kingdom

Location

London Chest Hospital

London, England, United Kingdom

Location

MeSH Terms

Conditions

Asthma; Lung Diseases; Respiratory Tract Diseases

Condition Hierarchy (Ancestors)

Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Dr. Eric Kleerup
• Organization: University of California, Los Angeles

ekleerup@mednet.ucla.edu

310-794-6593

Study Officials

• Christopher B Cooper, M.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 3, 2008
• First Posted: November 4, 2008
• Study Start: February 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: May 10, 2019
• Results First Posted: May 10, 2019

Record last verified: 2019-05

Locations

ZA (1); GB (2); US (3)