Albuterol to Improve Respiratory Strength in SCI
关键词
抽象
描述
Although the past 40 years has witnessed a substantial improvement in the acute and chronic management of persons with SCI, mortality remains high during the first year post-injury, and pulmonary complications including pneumonia, lung collapse (atelectasis), respiratory failure, and thromboembolism are the predominant cause. The propensity for pulmonary complications among subjects with SCI stems from paralysis of respiratory muscles. Injury to the cervical and upper thoracic cord significantly compromises function of the diaphragm, intercostal muscles, accessory respiratory muscles, and abdominal muscles. Respiratory muscle dysfunction is manifest as diminution in lung volumes, reduction in maximal static inspiratory and expiratory mouth pressures (MIP and MEP, respectively), and reduction in peak cough pressure and flow. Cough effectiveness is contingent upon both inspiratory and expiratory muscle strength; increasing the pressure-generating capacity of the inspiratory and expiratory muscles in persons with tetraplegia and high paraplegia may, therefore, translate to improved cough effectiveness and reduction in the propensity for atelectasis and, possibly, pneumonia.
Respiratory muscle training, often utilizing simple hand-held portable resistive or threshold training devices, appears to have marginal effects on vital capacity and maximal static mouth inspiratory and expiratory pressures (MIP and MEP, respectively), although data is inconclusive. Pharmacologic interventions to improve respiratory muscle strength have received little attention in the SCI population. Studies involving oral beta-2 adrenergic agonists, which have been shown to elicit anabolic effects on skeletal muscle in young men and an increase in muscle strength among patients with facioscapulohumeral muscular dystrophy, have also demonstrated salutary effects in persons with SCI. There are many foreseeable advantages of a pharmacologic approach to improve respiratory muscle strength in persons with SCI. For instance, RMT can be physically demanding and time consuming, compliance can be an issue, and sustainable improvements have not been realized. The intent in the present proposal is to enroll a targeted cohort of 24 comparatively weaker subjects with tetraplegia and high paraplegia in a randomized, double-blind, placebo-controlled, parallel group trial to assess the effects of an oral beta-2 agonist upon respiratory muscle strength and cough effectiveness.
日期
最后验证: | 05/31/2020 |
首次提交: | 07/14/2015 |
提交的预估入学人数: | 07/21/2015 |
首次发布: | 07/23/2015 |
上次提交的更新: | 06/21/2020 |
最近更新发布: | 06/24/2020 |
实际学习开始日期: | 05/31/2016 |
预计主要完成日期: | 03/01/2022 |
预计完成日期: | 06/01/2024 |
状况或疾病
干预/治疗
Drug: Active Oral Beta-2
Drug: Placebo
相
手臂组
臂 | 干预/治疗 |
---|---|
Active Comparator: Active Oral Beta-2 Subjects will receive 16 weeks of active medication. | Drug: Active Oral Beta-2 Subjects will receive extended release Albuterol, 4mg twice daily for the first week. The remaining 15 weeks subjects will receive extended release Albuterol, 8mg twice daily. |
Placebo Comparator: Placebo Subjects will receive 16 weeks of placebo medication. | Drug: Placebo Subjects will receive placebo tablets twice daily for 16 weeks. |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - Male or Female age 18 to 80 - Chronic spinal cord injury ( 1 year since injury) - Neurological level of injury between C3-C8 (Tetraplegia) - Neurological level of injury between T1-T6 (High Paraplegia) - Males with maximal inspiratory pressure (MIP) < 90 cmH2O or - Females with maximal inspiratory pressure (MIP) < 65 cmH2O Exclusion Criteria: - Smoking, active or history of smoking with the past year - Ventilator Dependence - History of blast injuries to the chest - Antidepressant use - History of asthma - Active respiratory disease or recent(within 3 months) respiratory infections - Uncontrolled hypertension or cardiovascular disease - Current use a beta-2 adrenergic agonists - History of epilepsy or seizure disorder - Hyperthyroidism - Currently taking corticosteroids - Currently taking monoamine oxidase inhibitors or tricyclic antidepressants - Hypersensitivity to albuterol or any of its' constituents - Pregnant - Use or are suspected of using over-the counter supplements or prescribed medications with anabolic characteristics (promotes improvements to muscle mass and strength) including, but not limited to: - creatine monohydrate - anabolic steroids (e.g., testosterone) - growth hormone - substances with similar actions or indications as those listed |
结果
主要结果指标
1. Change in Respiratory Muscle Strength [Baseline, Week 16, Week 18]