Use of an Oral Beta-2 Agonist in Persons With Spinal Cord Injury
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|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|
|Actual Primary Completion Date :||August 2012|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|