Use of an Oral Beta-2 Agonist in Persons With Spinal Cord Injury
|ClinicalTrials.gov Identifier: NCT00755079|
Recruitment Status : Completed
First Posted : September 18, 2008
Results First Posted : July 16, 2014
Last Update Posted : March 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Drug: extended release beta-2 adrenergic agonist Drug: placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Study Start Date :||April 2007|
|Primary Completion Date :||August 2012|
|Study Completion Date :||December 2014|
Placebo Comparator: Arm 1
group of persons with spinal cord injury will receive blinded placebo capsule
An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function.
Experimental: Arm 2
group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule
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.
- Inspiratory Respiratory Muscle Strength [ Time Frame: Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment. ]Respiratory muscle strength as measured by maximal inspiratory and pressures at the mouth.
- Expiratory Respiratory Muscle Strength [ Time Frame: Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment. ]Respiratory Muscle Strength defines as Maximal expiratory muscle strength at the mouth.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00755079
|United States, New York|
|VA Medical Center, Bronx|
|Bronx, New York, United States, 10468|
|Principal Investigator:||Greg Schilero, MD||VA Medical Center, Bronx|