Overview

This trial is active, not recruiting.

Condition spinal cord injury
Treatments extended release beta-2 adrenergic agonist, placebo
Phase phase 2/phase 3
Sponsor Department of Veterans Affairs
Start date April 2007
End date August 2012
Trial size 40 participants
Trial identifier NCT00755079, B4162-C

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Placebo Comparator)
group of persons with spinal cord injury will receive blinded placebo capsule
placebo
An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function.
(Experimental)
group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule
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.

Primary Outcomes

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.

Secondary Outcomes

Measure
Expiratory Respiratory Muscle Strength
time frame: Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment.

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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.

Additional Information

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
Principal investigator Greg Schilero, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Department of Veterans Affairs.