NCT00784758已完成不适用
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
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 11
- 主要终点
- Change in Asthma Control Questionnaire (ACQ) 7 Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Fenzian Device
Experimental
Subjects randomized to this arm will receive treatment with the Fenzian Device
干预措施: Fenzian Device (Device)
Sham Device
Sham Comparator
Subjects randomized to this arm will receive treatment with the sham device.
干预措施: Sham Device (Device)
结局指标
主要结局
Change in Asthma Control Questionnaire (ACQ) 7 Score
时间窗: Baseline to completion of treatment at 9 weeks
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.
次要结局
- 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)
- Change in Spirometry - FEV1/FVC(Baseline to completion of treatment at 9 weeks)
- Change in Spirometry FEF25-75%(Baseline to completion of treatment at 9 weeks)
- Change in Asthma Control Test Score(Baseline to completion of treatment at 9 weeks)
- Change in Mini Asthma Quality of Life Questionnaire (AQLQ) Score (to Evaluate Quality of Life)(Baseline to completion of treatment at 9 weeks)
- Change in Sino-Nasal Outcome Test (SNOT-22) - Total Score(Baseline to completion of treatment at 9 weeks)
- Change in SNOT-22 Nasal Sub-score(Baseline to completion of treatment at 9 weeks)
- Daytime Symptom Score(7 days prior to final assessment visit at week 15)
- Change in Transition Dyspnea Index (TDI) - Functional Impairment(Baseline to completion of treatment at 9 weeks)
- Change in Transition Dyspnea Index - Magnitude of Task at Visit 3(Baseline to completion of treatment at 9 weeks)
- Change in Transition Dyspnea Index - Magnitude of Effort at Visit 3(Baseline to completion of treatment at 9 weeks)
- Change in Transition Dyspnea Index - Functional Impairment(Baseline to final assessment visit (15 weeks))
- Change in Transition Dyspnea Index - Magnitude of Effort(Baseline to final assessment visit (15 weeks))
- Change in Transition Dyspnea Index - Magnitude of Task(Baseline to final assessment visit (15 weeks))
研究者
Eric Kleerup
Clinical Professor
University of California, Los Angeles
研究点 (11)
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