Albuterol to Improve Respiratory Strength in SCI

• Status: Active, not recruiting
• Trial end date: 2024-06-02
• Target enrollment: 0
• Participant gender: All

Summary

Spinal cord injury (SCI), especially involving the cervical and upper thoracic segments, can significantly compromise respiratory muscle function. Respiratory complications can ensue, including lung collapse and pneumonia, which are the primary cause for mortality in association with traumatic SCI both during the acute and chronic phases post-injury. Lesions at the level of the cervical or high thoracic spinal cord result in respiratory muscle weakness, which is associated with ineffective cough, mucus retention, and mucus plugging. Despite the fact that pulmonary complications are a major cause of morbidity and mortality in this population, there is a paucity of effective interventions in the SCI population known to improve respiratory muscle strength with pharmacologic interventions receiving little to no attention. The current objective of this study is to determine the effectiveness of 16 weeks of sustained release oral Albuterol to; (1) improve respiratory muscular strength, and (2) improve cough effectiveness.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Albuterol

Criteria

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