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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Spinal Cord Injury

In brief

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.

Key facts

Study ID

NCT00755079

Run by

US Department of Veterans Affairs

People needed

40

Starts

2007-04-01

Expected to finish

2014-12-01

Last updated by the study team

2015-03-17

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• VA Medical Center, Bronx — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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