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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00755079
First Posted: September 18, 2008
Last Update Posted: March 17, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
September 15, 2008
September 18, 2008
June 16, 2014
July 16, 2014
March 17, 2015
April 2007
August 2012   (Final data collection date for primary outcome measure)
Inspiratory Respiratory Muscle Strength [ Time Frame: 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.
Respiratory muscle strength, as measured by a number of lung function maneuvers [ Time Frame: Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment. ]
Complete list of historical versions of study NCT00755079 on ClinicalTrials.gov Archive Site
Expiratory Respiratory Muscle Strength [ Time Frame: 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.
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Use of an Oral Beta-2 Agonist in Persons With Spinal Cord Injury
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
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Spinal Cord Injury
  • Drug: extended release beta-2 adrenergic agonist
    Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles.
  • Drug: placebo
    An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function.
  • Placebo Comparator: Arm 1
    group of persons with spinal cord injury will receive blinded placebo capsule
    Intervention: Drug: placebo
  • Experimental: Arm 2
    group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule
    Intervention: Drug: extended release beta-2 adrenergic agonist
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
December 2014
August 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00755079
B4162-C
No
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VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Greg Schilero, MD VA Medical Center, Bronx
VA Office of Research and Development
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP