Status:
COMPLETED
Fenzian Asthma Multicenter Outcomes Study
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
Fenzian Ltd.
Conditions:
Asthma
Eligibility:
All Genders
12-80 years
Phase:
NA
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 medic...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00784758
Start Date
February 1 2009
End Date
June 1 2011
Last Update
May 10 2019
Active Locations (6)
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1
University of California, Los Angeles
Los Angeles, California, United States, 90095
2
Johns Hopkins University
Baltimore, Maryland, United States, 21205
3
Duke University Medical Center
Durham, North Carolina, United States, 27710
4
University of Cape Town Lung Institute
Mowbray, Cape Town, South Africa, 7700