Use of an Oral Beta-2 Agonist in Persons With Spinal Cord Injury

US Department of Veterans Affairs (VA)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Spinal Cord Injury

Treatments: Drug: extended release beta-2 adrenergic agonist; Drug: placebo

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00755079

B4162-C

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Arm 1

Placebo Comparator group

Description:

group of persons with spinal cord injury will receive blinded placebo capsule

Treatment:

Drug: placebo

Arm 2

Experimental group

Description:

group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule

Treatment:

Drug: extended release beta-2 adrenergic agonist