Trial Outcomes & Findings for Use of an Oral Beta-2 Agonist in Persons With Spinal Cord Injury (NCT NCT00755079)
NCT ID: NCT00755079
Last Updated: 2015-03-17
Results Overview
Respiratory muscle strength as measured by maximal inspiratory and pressures at the mouth.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
40 participants
Primary outcome timeframe
Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment.
Results posted on
2015-03-17
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
22
|
|
Overall Study
COMPLETED
|
17
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
6
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Use of an Oral Beta-2 Agonist in Persons With Spinal Cord Injury
Baseline characteristics by cohort
| Measure |
Placebo
n=17 Participants
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.
|
Active Drug
n=16 Participants
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.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.24 years
STANDARD_DEVIATION 9.53 • n=93 Participants
|
42.75 years
STANDARD_DEVIATION 14.74 • n=4 Participants
|
42.48 years
STANDARD_DEVIATION 12.14 • n=27 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=93 Participants
|
16 participants
n=4 Participants
|
33 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Placebo Control
n=17 Participants
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.
|
Active Drug
n=16 Participants
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.
|
|---|---|---|
|
Inspiratory Respiratory Muscle Strength
Maximal Inspiratory Pressure Baseline
|
82.35 cmH2O
Standard Deviation 18.07
|
79.19 cmH2O
Standard Deviation 29.72
|
|
Inspiratory Respiratory Muscle Strength
Maximal Inspiratory Pressure 12wk Post
|
85.31 cmH2O
Standard Deviation 24.51
|
91.69 cmH2O
Standard Deviation 32.04
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Placebo Control
n=17 Participants
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.
|
Active Drug
n=16 Participants
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.
|
|---|---|---|
|
Expiratory Respiratory Muscle Strength
Maximal Expiratory Pressure Baseline
|
84.65 cmH2O
Standard Deviation 36.82
|
70.38 cmH2O
Standard Deviation 35.95
|
|
Expiratory Respiratory Muscle Strength
Maximal Expiratory Pressure 12 week
|
88.31 cmH2O
Standard Deviation 30.12
|
77.44 cmH2O
Standard Deviation 37.89
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Drug
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=18 participants at risk
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.
|
Active Drug
n=22 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle Cramping
|
0.00%
0/18
|
4.5%
1/22 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place