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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-blind, Placebo-controlled Parallel Group Trial to Determine the Effect of an Oral Beta-2 Agonist on Respiratory Muscle Strength in Spinal Cord Injury

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Drug: extended release beta-2 adrenergic agonist
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Arm 1<br>group of persons with spinal cord injury will receive blinded placebo capsule | Drug: placebo<br>* An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function.<br>|
| Experimental: Arm 2<br>group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule | Drug: extended release beta-2 adrenergic agonist<br>* Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inspiratory Respiratory Muscle Strength | Respiratory muscle strength as measured by maximal inspiratory and pressures at the mouth. | Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment. | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal cord injury, beta-2 agonist, respiratory muscle strength, pulmonary function test