Aerosolized Beta-Agonist Isomers in Asthma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- Change in Maximum Forced Expiratory Volume at One Second (FEV1)
研究概览
简要总结
Dr. MacIntyre and his colleagues are studying inhaled medications in asthma. There are two new medications that have been approved by the United States Food and Drug Administration (FDA): levalbuterol and formoterol. Both of these drugs are similar to standard asthma bronchodilator drugs but offer theoretical advantages in terms of fewer side effects. There are also newer devices to deliver these medications into the lungs: breath actuated nebulizers (BANs) and non-static chambers (Aerochamber-max) that can be used with metered dose inhalers (MDIs or "puffers"). The purpose of this study is to deliver these new medications using several different devices and measuring lung function, heart rate, and sensations of breathlessness.
详细描述
Patients will be studied on five separate mornings. The duration of the study and frequency of the visits will be solely dependant on the subject availability. Each subject will receive all 5 treatments in the same order.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stable mild to moderate persistent asthma as defined by the National Asthma Education and Prevention Program
- •greater than 18 years of age
- •requiring bronchodilator therapy either routinely or on a as needed (PRN)basis
- •stable with respect to respiratory disease and at least four weeks removed from the most recent acute exacerbation of the disease
- •patients may or may not be on inhaled corticosteroids
排除标准
- •no unstable cardiovascular symptoms
- •no unstable angina
- •must be at least four weeks removed from an acute coronary syndrome
研究组 & 干预措施
levalbuterol + saline in a breath actuated nebulizer
0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer
干预措施: levalbuterol (Drug)
levalbuterol + saline in a breath actuated nebulizer
0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer
干预措施: saline (Drug)
levalbuterol + saline in a breath actuated nebulizer
0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer
干预措施: breath actuated nebulizer (Device)
levalbuterol + ipratroprium in a breath actuated nebulizer
0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer
干预措施: levalbuterol (Drug)
levalbuterol + ipratroprium in a breath actuated nebulizer
0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer
干预措施: breath actuated nebulizer (Device)
levalbuterol + ipratroprium in a breath actuated nebulizer
0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer
干预措施: ipratroprium (Drug)
levalbuterol MDI 2 puffs
levalbuterol metered dose inhaler 2 puffs
干预措施: levalbuterol MDI (Other)
levalbuterol MDI + aerochamber max without pause 2 puffs
levalbuterol MDI + aerochamber max without pause 2 puffs
干预措施: levalbuterol MDI (Other)
levalbuterol MDI + aerochamber max without pause 2 puffs
levalbuterol MDI + aerochamber max without pause 2 puffs
干预措施: aerochamber max (Device)
levalbuterol MDI + aerochamber max with 2 second pause 2 puffs
levalbuterol MDI + aerochamber max with 2 second pause 2 puffs
干预措施: levalbuterol MDI (Other)
levalbuterol MDI + aerochamber max with 2 second pause 2 puffs
levalbuterol MDI + aerochamber max with 2 second pause 2 puffs
干预措施: aerochamber max (Device)
结局指标
主要结局
Change in Maximum Forced Expiratory Volume at One Second (FEV1)
时间窗: Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment
次要结局
- Change in 8 Hour Area-under-the-curve FEV1(0 to 8 hours post dose)
- Change in Heart Rate(Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment)
- Change in Tremor Assessment Measured by a Scale(Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment)
- Change in Dyspnea Response as Measured by the University of California, San Diego (UCSD) Dyspnea Scale(Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment)