Use of an Oral Beta-2 Agonist in Persons With Spinal Cord Injury
Information source: Department of Veterans Affairs
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Spinal Cord Injury
Intervention: extended release beta-2 adrenergic agonist (Drug); placebo (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Department of Veterans Affairs Official(s) and/or principal investigator(s): Greg Schilero, MD, Principal Investigator, Affiliation: VA Medical Center, Bronx
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Inspiratory Respiratory Muscle Strength
Secondary outcome: Expiratory Respiratory Muscle Strength
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
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
Locations and Contacts
VA Medical Center, Bronx, Bronx, New York 10468, United States
Additional Information
Starting date: April 2007
Last updated: February 24, 2015
|