A Randomized, Double-blind, Placebo-controlled Parallel Group Trial to Determine the Effect of an Oral Beta-2 Agonist on Respiratory Muscle Strength in Spinal Cord Injury
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Inspiratory Respiratory Muscle Strength
研究概览
简要总结
The primary purpose of this study is to determine the effect of administration of the oral beta-2 adrenergic agonist, albuterol, on respiratory muscle strength in individuals with cervical (neck) and high thoracic (upper back) spinal cord injury and to compare findings with those obtained in a demographically matched group that will receive placebo. Participation in this study will involve 12 weeks of pharmacological intervention during which participants will be randomized to receive either oral albuterol 4mg twice daily or placebo. All investigators and study participants will be blinded to randomization by our research pharmacy. Participation in the study will require study subjects to come to our lab for the total of 2 visits (at baseline and after week 12), during which a series of tests will be performed to assess their respiratory muscle strength and pulmonary function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Chronic Spinal Cord Injury (>1 year post-injury)
- •All American Spinal Injury Association (ASIA) classifications
- •High Paraplegia (level of injury T1-T6)
- •Tetraplegia (level of injury C2-C8, non-ventilator dependent)
排除标准
- •history of asthma
- •uncontrolled hypertension or cardiovascular disease
- •those using beta-2 adrenergic agonists
- •epilepsy or seizure disorder
- •hyperthyroidism
- •chronic corticosteroid use
- •those taking monoamine oxidase inhibitors or Tricyclic antidepressants for depression
- •hypersensitivity to albuterol or any of its' delete components
- •pregnancy
- •use of ergogenic aids or supplements with anabolic characteristics including, but not limited to:
- •creatine monohydrate
- •anabolic steroids (e.g., testosterone)
- •growth hormone and their analogs and/or derivatives
研究组 & 干预措施
Arm 1
group of persons with spinal cord injury will receive blinded placebo capsule
干预措施: placebo (Drug)
Arm 2
group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule
干预措施: extended release beta-2 adrenergic agonist (Drug)
结局指标
主要结局
Inspiratory Respiratory Muscle Strength
时间窗: Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment.
Respiratory muscle strength as measured by maximal inspiratory and pressures at the mouth.
次要结局
- Expiratory Respiratory Muscle Strength(Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment.)