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
  Purpose

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.


Condition Intervention Phase
Spinal Cord Injury
Drug: extended release beta-2 adrenergic agonist
Drug: placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 40
Study Start Date: April 2007
Estimated Study Completion Date: December 2014
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm 1
group of persons with spinal cord injury will receive blinded placebo capsule
Drug: placebo
An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function.
Experimental: Arm 2
group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00755079

Locations
United States, New York
VA Medical Center, Bronx
Bronx, New York, United States, 10468
Sponsors and Collaborators
Investigators
Principal Investigator: Greg Schilero, MD VA Medical Center, Bronx
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00755079     History of Changes
Other Study ID Numbers: B4162-C
Study First Received: September 15, 2008
Results First Received: June 16, 2014
Last Updated: July 31, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
spinal cord injury
beta-2 agonist
respiratory muscle strength
pulmonary function test

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Adrenergic Agents
Adrenergic Agonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 27, 2014