Albuterol and Dynamic Hyperinflation in Idiopathic Pulmonary Arterial Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- End-expiratory lung volume:total lung capacity (EELV/TLC) ratio at matched metabolic isowork.
研究概览
简要总结
The purpose of this study is to determine if dynamic hyperinflation seen in patients with idiopathic pulmonary artery hypertension (iPAH) improves with albuterol therapy.
详细描述
Only a few small studies have evaluated the relationship between iPAH, expiratory flow limitation, and exercise dyspnea. While not all patients with iPAH demonstrate airway involvement, those who demonstrate dynamic hyperinflation (DH), defined as a variable and temporary increase in end-expiratory lung volume, report increased dyspnea with exertion on maximal testing. There is a continued need for adjuvant therapy in iPAH, and bronchodilators have the potential to ameliorate dyspnea during exercise, which could lead to improved quality of life in this disabling condition. This study will investigate the presence of airway involvement in this population as measured by dynamic hyperinflation, and if there is any improvement in function with the use of inhaled albuterol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •18 years of age or greater.
- •Idiopathic Pulmonary Arterial Hypertension, or Familial Pulmonary Arterial Hypertension.
- •Forced expiratory flow 75% (FEF75%) of ≤ 65% of predicted.
排除标准
- •Clinical instability or change in medication therapy in preceding 3 months.
- •Allergy or intolerance to inhaled albuterol.
- •Body mass index > 30
- •Active tobacco use, or > 10 pack-year smoking history.
- •Lung disease other than pulmonary hypertension
- •Forced expiratory volume in 1 second (FEV1) ≤ 80% of predicted.
- •Pregnancy
- •Inability to perform pulmonary function testing.
- •Inability to perform cardiopulmonary exercise testing.
- •Supplemental oxygen requirement.
- •Inability to read and understand English.
- •Historical 6-minute walk distance <150 meters
研究组 & 干预措施
Albuterol
2.5 mg of albuterol inhaled via jet nebulizer 15 minutes prior to symptom-limited maximal CPET.
干预措施: Albuterol. (Drug)
Placebo
Normal saline placebo inhaled via jet nebulizer 15 minutes prior to symptom-limited maximal CPET.
干预措施: Normal saline placebo (Drug)
结局指标
主要结局
End-expiratory lung volume:total lung capacity (EELV/TLC) ratio at matched metabolic isowork.
时间窗: up to 3 days
Determined by measuring inspiratory capacity every 2 minutes during cardiopulmonary exercise test (CPET)
次要结局
- Change in peak oxygen consumption with albuterol(Study days 2 and 3)
- Change in O2 pulse with albuterol.(Study days 2 and 3)
- Borg dyspnea score(Days 2 and 3)
- Exercise time(Study days 2 and 3)
研究者
Matthew Lammi
Assistant Professor of Medicine, Section of Pulmonary and Critical Care
Louisiana State University Health Sciences Center in New Orleans