Trial Outcomes & Findings for Optimal Albuterol Regimens for Acute Asthma Exacerbations: DBRCT Pilot Study (NCT NCT01196377)
NCT ID: NCT01196377
Last Updated: 2017-09-29
Results Overview
% predicted forced expiratory volume in 1-second as a measure of airway obstruction
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
2 hours
Results posted on
2017-09-29
Participant Flow
We recruited 16 patients ages 5 to 17 years for this double blind randomized trial.
Participant milestones
| Measure |
Nebulized Albuterol 10mg/hr Continuous
Active control arm, 10mg/hr continuous.
|
10mg/hr Pulsed
Experimental 10mg/hr pulsed albuterol regimen.
|
25mg/hr Continuous
Experimental 25mg/hr continuous albuterol.
|
25mg/hr Pulsed
Experimental 25mg/hr pulsed
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optimal Albuterol Regimens for Acute Asthma Exacerbations: DBRCT Pilot Study
Baseline characteristics by cohort
| Measure |
Nebulized Albuterol 10mg/hr Continuous
n=4 Participants
Active control arm, 10mg/hr continuous.
|
10mg/hr Pulsed
n=4 Participants
Experimental 10mg/hr pulsed albuterol regimen.
|
25mg/hr Continuous
n=4 Participants
Experimental 25mg/hr continuous albuterol.
|
25mg/hr Pulsed
n=4 Participants
Experimental 25mg/hr pulsed
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
7.8 years
STANDARD_DEVIATION 2 • n=5 Participants
|
7.9 years
STANDARD_DEVIATION 2 • n=7 Participants
|
7.6 years
STANDARD_DEVIATION 4 • n=5 Participants
|
7.7 years
STANDARD_DEVIATION 2 • n=4 Participants
|
7.7 years
STANDARD_DEVIATION 2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
4 participants
n=4 Participants
|
16 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 2 hours% predicted forced expiratory volume in 1-second as a measure of airway obstruction
Outcome measures
| Measure |
Nebulized Albuterol 10mg/hr Continuous
n=4 Participants
Active control arm, 10mg/hr continuous.
Albuterol: Nebulized albuterol
|
10mg/hr Pulsed
n=4 Participants
Experimental 10mg/hr pulsed albuterol regimen.
Albuterol: Nebulized albuterol
|
25mg/hr Continuous
n=4 Participants
Experimental 25mg/hr continuous albuterol.
Albuterol: Nebulized albuterol
|
25mg/hr Pulsed
n=4 Participants
Experimental 25mg/hr pulsed
Albuterol: Nebulized albuterol
|
|---|---|---|---|---|
|
%FEV1
Baseline, pretreatment
|
20 %-predicted
Interval 17.0 to 25.0
|
34 %-predicted
Interval 19.0 to 41.0
|
26 %-predicted
Interval 16.0 to 36.0
|
31 %-predicted
Interval 14.0 to 41.0
|
|
%FEV1
2-hours (post-treatment)
|
41 %-predicted
Interval 32.0 to 48.0
|
47 %-predicted
Interval 17.0 to 77.0
|
67 %-predicted
Interval 61.0 to 73.0
|
44 %-predicted
Interval 34.0 to 55.0
|
Adverse Events
Nebulized Albuterol 10mg/hr Continuous
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
10mg/hr Pulsed
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
25mg/hr Continuous
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
25mg/hr Pulsed
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Donald H Arnold
Vanderbilt University School of Medicine
Phone: 6155790516
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place