Loading clinical trials...

COMPLETEDNA

Fenzian Asthma Multicenter Outcomes Study

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

NCT00784758•University of California, Los Angeles

View on ClinicalTrials.gov

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

Age

12 - 80 years

Sex

ALL

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
•Pre-bronchodilator forced expiratory volume at one second (FEV1) between 60% predicted and the lower limit of normal.
+9 more criteria

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.
+10 more criteria

Locations (6)

University of California, Los Angeles

Los Angeles, California, United States

Johns Hopkins University

Baltimore, Maryland, United States

Duke University Medical Center

Durham, North Carolina, United States

University of Cape Town Lung Institute

Mowbray, Cape Town, South Africa

Addenbrookes NHS Trust, Cambridge University

Bottisham, Cambridgeshire, United Kingdom

London Chest Hospital

London, England, United Kingdom

Key Dates

Start Date

February 1, 2009

Primary Completion Date

June 1, 2011

Completion Date

June 1, 2011

Last Updated

May 10, 2019

Enrollment

ACTUAL participants

Conditions

Asthma

Interventions

Fenzian Device

DEVICE

Sham Device

DEVICE

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

NCT07219173

Asthma

View study

RECRUITINGNA

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NCT07486401

Asthma ExacerbationsBiomarkers / Blood+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 10, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Fenzian Asthma Multicenter Outcomes Study

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

To Assess the Management of Patients on Global Initiative of Asthma (GINA) Step 4 and 5 Treatment in Hong Kong

A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma