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

NCT00755079 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-03-17

Study results available
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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

Interventions

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.

DRUG

placebo

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

Sponsors & Collaborators

Principal Investigators

  • Greg Schilero, MD · VA Medical Center, Bronx

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2012-08-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00755079 on ClinicalTrials.gov