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

Phase 2

Completed

• Conditions: Spinal Cord Injury
• Interventions: Drug: placebo; Drug: extended release beta-2 adrenergic agonist

• Registration Number: NCT00755079
• Lead Sponsor: US Department of Veterans Affairs

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2008-09-15
• Study First Submitted QC: 2008-09-16
• Study First Posted: 2008-09-18
• Primary Completion: 2012-08
• Results First Submitted: 2014-06-16
• Results First Submitted QC: 2014-06-16
• Results First Posted: 2014-07-16
• Study Completion: 2014-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-24
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	placebo	group of persons with spinal cord injury will receive blinded placebo capsule
Arm 2	extended release beta-2 adrenergic agonist	group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule

Primary Outcome Measures

Name	Time	Method
Inspiratory Respiratory Muscle Strength	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.

Secondary Outcome Measures

Name	Time	Method
Expiratory Respiratory Muscle Strength	Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment.	Respiratory Muscle Strength defines as Maximal expiratory muscle strength at the mouth.

Trial Locations

Locations (1)

VA Medical Center, Bronx; 🇺🇸 Bronx, New York, United States