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

NCT00755079 | Completed Phase 2 Results

• 1 other identifier: B4162-C
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

spinal cord injury; beta-2 agonist; respiratory muscle strength; pulmonary function test

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Expiratory Respiratory Muscle Strength

  Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment.

Study Arms (2)

Arm 1

PLACEBO COMPARATOR

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

Drug: placebo

Arm 2

EXPERIMENTAL

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

Drug: extended release beta-2 adrenergic agonist

Interventions

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.

Arm 2

placebo DRUG

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

Arm 1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Medical Center, Bronx

The Bronx, New York, 10468, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Joshua Hobson, MS
• Organization: VAHSRD

joshua.hobson@va.gov

(718) 584-9000

Study Officials

• Greg Schilero, MD

  VA Medical Center, Bronx

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2008
• First Posted: September 18, 2008
• Study Start: April 1, 2007
• Primary Completion: August 1, 2012
• Study Completion: December 1, 2014
• Last Updated: March 17, 2015
• Results First Posted: July 16, 2014

Record last verified: 2015-02

Locations

US (1)