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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00755079
First received: September 15, 2008
Last updated: July 31, 2014
Last verified: July 2014

September 15, 2008
July 31, 2014
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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
Respiratory Muscle Strength defines as Maximal expiratory muscle strength at the mouth.
Not Provided
Not Provided
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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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.
 
Active, not recruiting
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.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00755079
B4162-C
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Greg Schilero, MD VA Medical Center, Bronx
Department of Veterans Affairs
July 2014

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