Ventilation and Perfusion in Individuals With Asthma
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Regional Ventilation
研究概览
简要总结
Assess regional changes to perfusion and ventilation from inhaled corticosteroid (ICS) and Fast-acting beta-antagonist (FABA) among adult asthmatics using radiographically derived estimates of regional ventilation (V-distribution), ventilation defect percentage (VDP), and ventilation heterogeneity (VH).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician diagnosis of asthma
- •Baseline Forced Expiratory Volume in 1 Second (FEV1) < 80% of predicted, with reversibility (10%) on post-bronchodilator spirometry
- •Adults, 18-75 years of age
- •Long-term inhaled controller medication consisting of or including an Inhaled corticosteroids (ICS) at a steady dose for at least 3 months before enrollment
排除标准
- •Current cigarette smoking or a past history of >10 pack-year smoking
- •Current nicotine vaping
- •Pregnant and breast-feeding women
- •Respiratory infection within 4 weeks of proposed study date
- •Forced Expiratory Volume in 1 Second (FEV1) < 50%
- •Inhaled corticosteroids (ICS)/fast-acting beta agonist (FABA) intolerance
- •Use of beta-blockers
- •Use of systemic glucocorticosteroids or oral methyl-xanthines within 30 days of planned study visit.
研究组 & 干预措施
Albuterol Sulfate followed by AIRSUPRA (Albuterol/Budesonide)
All participants in this single-arm study will complete 2 study visits, each lasting approximately 1 hour. Interventions will be administered in a sequential order.
- Visit 1: Participants will inhale Albuterol Sulfate via metered-dose inhaler (MDI) with spacer
- Visit 2: Participants will inhale AIRSUPRA (Albuterol/Budesonide) via metered-dose inhaler (MDI) with spacer as the second stage of treatment.
干预措施: Albuterol Sulfate (Drug)
Albuterol Sulfate followed by AIRSUPRA (Albuterol/Budesonide)
All participants in this single-arm study will complete 2 study visits, each lasting approximately 1 hour. Interventions will be administered in a sequential order.
- Visit 1: Participants will inhale Albuterol Sulfate via metered-dose inhaler (MDI) with spacer
- Visit 2: Participants will inhale AIRSUPRA (Albuterol/Budesonide) via metered-dose inhaler (MDI) with spacer as the second stage of treatment.
干预措施: Albuterol-Budesonide (Drug)
结局指标
主要结局
Change in Regional Ventilation
时间窗: Baseline, 30 minutes after budesonide administration
Regional ventilation will be measured using functional lung imaging (XV LVAS) before and after inhalation of Albuterol/Budesonide. The outcome will be defined as the change in voxel-wise ventilation distribution from end expiration to peak inspiration, normalized to regional lung volume.
次要结局
- Percent Change in FVC (Forced Vital Capacity)(Baseline, 60 minutes after budesonide administration)
- Change in Regional Mean Specific Perfusion(Baseline, 30 minutes after budesonide administration)
- Percent Change in FEV₁ (Forced Expiratory Volume in 1 second)(Baseline, 60 minutes after budesonide administration)
- Percent Change FEV₁/Forced Expiratory Volume (FVC) Ratio (Unitless)(Baseline, 30 minutes after budesonide administration)
研究者
Trishul Siddharthan
Associate Professor of Medicine
University of Miami