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

NCT ID: NCT00755079

Last Updated: 2015-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2014-12-31

Brief 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.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Arm 1

group of persons with spinal cord injury will receive blinded placebo capsule

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

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

Arm 2

group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule

Group Type: EXPERIMENTAL

extended release beta-2 adrenergic agonist

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

placebo

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Greg Schilero, MD

Role: PRINCIPAL_INVESTIGATOR

VA Medical Center, Bronx

Locations

VA Medical Center, Bronx

The Bronx, New York, United States

Countries

United States

Other Identifiers

B4162-C

Identifier Type: -

Identifier Source: org_study_id