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Completed

NCT Number: NCT00755079

Use of an Oral Beta-2 Agonist in Persons With 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.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

VA Medical Center, Bronx

The Bronx, New York, 10468, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

extended release beta-2 adrenergic agonist

Drug

Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles.

Placebo

Drug

An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2012
Study completion
2014
First posted
Sep 18, 2008
Registry last updated
Mar 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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