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

Spinal Cord Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00755079
• Other study ID #: B4162-C
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 15, 2008
• Last updated: February 24, 2015
• Start date: April 2007
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2014
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

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

Locations

Country	Name	City	State
United States	VA Medical Center, Bronx	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inspiratory Respiratory Muscle Strength	Respiratory muscle strength as measured by maximal inspiratory and pressures at the mouth.	Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment.	No
Secondary	Expiratory Respiratory Muscle Strength	Respiratory Muscle Strength defines as Maximal expiratory muscle strength at the mouth.	Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment.	No