A Study Comparing Measures of Ventilatory Heterogeneity (VH) in Asthma Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change from baseline in VH assessed by oxygen-enhanced 1H MRI (Oe 1H MRI) after two weeks of montelukast or prednisone treatment
研究概览
简要总结
This study will explore the utility of magnetic resonance imaging (MRI) to assess ventilatory defects that occur due to asthma, determine the sensitivity and specificity of MRI in response to drug treatment, and whether MRI can serve as a biomarker of treatment effects due to asthma therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
All Participants
Participants (male or female) that are between 18-65 years of age with a clinical diagnosis of asthma will take montelukast for 2 weeks (treatment period 1) and then take prednisone for 2 weeks (treatment period 2)
干预措施: Montelukast (Drug)
All Participants
Participants (male or female) that are between 18-65 years of age with a clinical diagnosis of asthma will take montelukast for 2 weeks (treatment period 1) and then take prednisone for 2 weeks (treatment period 2)
干预措施: Prednisone (Drug)
结局指标
主要结局
Change from baseline in VH assessed by oxygen-enhanced 1H MRI (Oe 1H MRI) after two weeks of montelukast or prednisone treatment
时间窗: Baseline and after two weeks of drug treatment
Change from baseline in VH assessed by 19F-perfluoropropane MRI (19F MRI) after two weeks of montelukast or prednisone treatment
时间窗: Baseline and after two weeks of drug treatment
Change from baseline in VH assessed by Conducting Airway Heterogeneity (Scond) after two weeks of montelukast or prednisone treatment
时间窗: Baseline and after two weeks of drug treatment
Change from baseline in VH assessed by Lung Clearance Index (LCI) after two weeks of montelukast or prednisone treatment
时间窗: Baseline and after two weeks of drug treatment
Change from baseline in VH assessed by Forced Expiratory Volume in 1 second (FEV1) after two weeks of montelukast or prednisone treatment
时间窗: Baseline and after two weeks of drug treatment
次要结局
- Comparison of VH assessed by Oe 1H MRI, 19F MRI, LCI, Scond and FEV1 at baseline(Baseline)
- Short-term test-retest repeatability of VH by Oe 1H MRI and 19F MRI(Visit 2 and Visit 3)
- Mid-term test-retest repeatability of VH by Oe 1H MRI and 19F MRI(Visit 3 and Visit 4/Visit 5)
研究者
Hal C Charles
Associate Professor
Duke University