An Open-Label, Dose-Escalating, Study to Evaluate the Safety, Efficacy and Tolerability of Oral Nadolol for the Treatment of Adults With Mild Asthma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Mean Daily Dose at Study Termination Across Participants
研究概览
简要总结
The purpose of this study is to confirm previous observations in asthmatics that chronic nadolol treatment reduces asthmatic airway hyper-responsiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pre-bronchodilator FEV1 80% or greater than the predicted value.
- •PC20 FEV1 ≤4 mg/ml on methacholine challenge test.
- •Blood Pressure ≥ 100/65mm Hg.
- •Pulse rate ≥ 60 beats/min.
- •No significant health issues.
- •Non-smoker or X-smoker < 10 pack/year.
排除标准
- •History of upper/lower respiratory tract infection or asthma exacerbation within 6 weeks of first baseline visit.
- •Currently diagnosed with chronic obstructive pulmonary disease (COPD).
- •Used any oral or inhaled corticosteroids within 4 weeks of the first baseline visit.
研究组 & 干预措施
Open Label treatment with oral Nadolol
Dose escalation through 1.25mgs, 2.5mgs, 5.0mgs, 10mgs, 20mgs, and 40mgs of nadolol at 2 week intervals as tolerated.
干预措施: nadolol (Drug)
结局指标
主要结局
Mean Daily Dose at Study Termination Across Participants
时间窗: Baseline to end of study (105 days)
The outcome measure describes the mean daily dose achieved by the subjects at study termination. This data includes one subject who terminated early, having reached 2.5mgs and subsequently reducing to 1.25mgs prior to dropping out.
Daily Dose at Study Termination Across Participants
时间窗: Baseline to end of study (105 days)
The outcome measure describes the final daily dose achieved by the subjects in this study. The subjects described below who finished on less than the highest dose (i.e., 1.25, 5, and 10mgs) had all been down-titrated one dose (i.e., from 2.5, 10, and 20mgs) prior to completing the study on the dose reported.
次要结局
- Change in Airway Hyper-reactivity Compared to Baseline (Change in PC20 Doubling Dose by Methacholine Challenge)(Baseline to end of study (105 days))
- Percent Change in FEV1% Predicted From Baseline to End of Study(Baseline to end of study (105 days))
- Change in Asthma Control Questionnaire (ACQ) Score Compared to Baseline(Baseline to end of study (105 days))