Spinal Cord Injury
Conditions
Keywords
spinal cord injury, beta-2 agonist, respiratory muscle strength, pulmonary function test
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.
Interventions
DRUGextended 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.
DRUGplacebo
An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function.
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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)
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: * creatine monohydrate * anabolic steroids (e.g., testosterone) * growth hormone and their analogs and/or derivatives
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inspiratory Respiratory Muscle Strength | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Expiratory Respiratory Muscle Strength | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 17 |
| 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. | 16 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Placebo | Active Drug | Total |
|---|---|---|---|
| Age, Continuous | 42.24 years STANDARD_DEVIATION 9.53 | 42.75 years STANDARD_DEVIATION 14.74 | 42.48 years STANDARD_DEVIATION 12.14 |
| Region of Enrollment United States | 17 participants | 16 participants | 33 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 16 Participants | 15 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 18 | 0 / 22 |
| serious Total, serious adverse events | 0 / 18 | 1 / 22 |
Outcome results
Primary
Inspiratory Respiratory Muscle Strength
Respiratory muscle strength as measured by maximal inspiratory and pressures at the mouth.
Time frame: Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Control | Inspiratory Respiratory Muscle Strength | Maximal Inspiratory Pressure Baseline | 82.35 cmH2O | Standard Deviation 18.07 |
| Placebo Control | Inspiratory Respiratory Muscle Strength | Maximal Inspiratory Pressure 12wk Post | 85.31 cmH2O | Standard Deviation 24.51 |
| Active Drug | Inspiratory Respiratory Muscle Strength | Maximal Inspiratory Pressure Baseline | 79.19 cmH2O | Standard Deviation 29.72 |
| Active Drug | Inspiratory Respiratory Muscle Strength | Maximal Inspiratory Pressure 12wk Post | 91.69 cmH2O | Standard Deviation 32.04 |
Secondary
Expiratory Respiratory Muscle Strength
Respiratory Muscle Strength defines as Maximal expiratory muscle strength at the mouth.
Time frame: Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Control | Expiratory Respiratory Muscle Strength | Maximal Expiratory Pressure Baseline | 84.65 cmH2O | Standard Deviation 36.82 |
| Placebo Control | Expiratory Respiratory Muscle Strength | Maximal Expiratory Pressure 12 week | 88.31 cmH2O | Standard Deviation 30.12 |
| Active Drug | Expiratory Respiratory Muscle Strength | Maximal Expiratory Pressure Baseline | 70.38 cmH2O | Standard Deviation 35.95 |
| Active Drug | Expiratory Respiratory Muscle Strength | Maximal Expiratory Pressure 12 week | 77.44 cmH2O | Standard Deviation 37.89 |