Trial Outcomes & Findings for Albuterol to Improve Respiratory Strength in SCI (NCT NCT02508311)
NCT ID: NCT02508311
Last Updated: 2024-05-07
Results Overview
Respiratory muscle strength will be determined by maximal inspiratory pressure and maximal expiratory pressure at the mouth during baseline visit, week 16 visit and week 18 visit.
TERMINATED
PHASE4
1 participants
Baseline, Week 16, Week 18
2024-05-07
Participant Flow
Several participants failed screening, and thus were not randomized to either the treatment or placebo arm.
Participant milestones
| Measure |
Active Oral Beta-2
Subjects will receive 16 weeks of active medication.
Oral Albuterol Extended Release: Subjects will receive extended release Albuterol, 4mg twice daily for the first week. The remaining 15 weeks subjects will receive extended release Albuterol, 8mg twice daily.
|
Placebo
Subjects will receive 16 weeks of placebo medication.
Placebo: Subjects will receive placebo tablets twice daily for 16 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Active Oral Beta-2
Subjects will receive 16 weeks of active medication.
Oral Albuterol Extended Release: Subjects will receive extended release Albuterol, 4mg twice daily for the first week. The remaining 15 weeks subjects will receive extended release Albuterol, 8mg twice daily.
|
Placebo
Subjects will receive 16 weeks of placebo medication.
Placebo: Subjects will receive placebo tablets twice daily for 16 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Albuterol to Improve Respiratory Strength in SCI
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Baseline, Week 16, Week 18Population: 1 participant screened and qualifies; however the participant dropped out. No data on this participant was collected.
Respiratory muscle strength will be determined by maximal inspiratory pressure and maximal expiratory pressure at the mouth during baseline visit, week 16 visit and week 18 visit.
Outcome measures
Outcome data not reported
Adverse Events
Active Oral Beta-2
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place