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

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
extended release beta-2 adrenergic agonist
placebo
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring spinal cord injury, beta-2 agonist, respiratory muscle strength, pulmonary function test

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • VA Medical Center, Bronx

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm 1

Arm 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Inspiratory Respiratory Muscle Strength
Respiratory muscle strength as measured by maximal inspiratory and pressures at the mouth.

Secondary Outcome Measures

Expiratory Respiratory Muscle Strength
Respiratory Muscle Strength defines as Maximal expiratory muscle strength at the mouth.

Full Information

First Posted
September 15, 2008
Last Updated
February 24, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00755079
Brief Title
Use of an Oral Beta-2 Agonist in Persons With Spinal Cord Injury
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
spinal cord injury, beta-2 agonist, respiratory muscle strength, pulmonary function test

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Placebo Comparator
Arm Description
group of persons with spinal cord injury will receive blinded placebo capsule
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule
Intervention Type
Drug
Intervention Name(s)
extended release beta-2 adrenergic agonist
Intervention Description
Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function.
Primary Outcome Measure Information:
Title
Inspiratory Respiratory Muscle Strength
Description
Respiratory muscle strength as measured by maximal inspiratory and pressures at the mouth.
Time Frame
Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment.
Secondary Outcome Measure Information:
Title
Expiratory Respiratory Muscle Strength
Description
Respiratory Muscle Strength defines as Maximal expiratory muscle strength at the mouth.
Time Frame
Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Greg Schilero, MD
Organizational Affiliation
VA Medical Center, Bronx
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center, Bronx
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States

12. IPD Sharing Statement

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

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