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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Placebo Comparator | group of persons with spinal cord injury will receive blinded placebo capsule |
|
| Arm 2 | Experimental | group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Expiratory Respiratory Muscle Strength | Respiratory Muscle Strength defines as Maximal expiratory muscle strength at the mouth. | Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment. |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Greg Schilero, MD | VA Medical Center, Bronx | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Medical Center, Bronx | The Bronx | New York | 10468 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Control | group of persons with spinal cord injury will receive blinded placebo capsule placebo: An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function. |
| FG001 | Active Drug | group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | group of persons with spinal cord injury will receive blinded placebo capsule placebo: An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function. |
| BG001 | Active Drug |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Inspiratory Respiratory Muscle Strength | Respiratory muscle strength as measured by maximal inspiratory and pressures at the mouth. | Posted | Mean | Standard Deviation | cmH2O | Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | group of persons with spinal cord injury will receive blinded placebo capsule placebo: An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle Cramping | Musculoskeletal and connective tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joshua Hobson, MS | VAHSRD | (718) 584-9000 | 3129 | joshua.hobson@va.gov |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| placebo | Drug | An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function. |
|
| Withdrawal by Subject |
|
group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Expiratory Respiratory Muscle Strength | Respiratory Muscle Strength defines as Maximal expiratory muscle strength at the mouth. | Posted | Mean | Standard Deviation | cmH2O | Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment. |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Active Drug | group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule 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. | 1 | 22 | 0 | 22 |
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| D014947 | Wounds and Injuries |