Trial Outcomes & Findings for Continuous Levalbuterol for Treatment of Status Asthmaticus in Children (NCT NCT00124176)
NCT ID: NCT00124176
Last Updated: 2013-03-14
Results Overview
standard intention to treat (ITT) analysis
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
81 participants
Primary outcome timeframe
During hospitalization
Results posted on
2013-03-14
Participant Flow
Participant milestones
| Measure |
Continuous Levalbuterol (R) Nebulized Solution
Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
|
Continuous Racemic (R+S) Albuterol
Continuous racemic albuterol 20mg/hr given as continuous nebulization
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
41
|
|
Overall Study
Received Study Drug
|
37
|
41
|
|
Overall Study
COMPLETED
|
40
|
41
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Continuous Levalbuterol for Treatment of Status Asthmaticus in Children
Baseline characteristics by cohort
| Measure |
Continuous Levalbuterol (R) Nebulized Solution
n=40 Participants
Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
|
Continuous Racemic (R+S) Albuterol
n=41 Participants
Continuous racemic albuterol 20mg/hr given as continuous nebulization
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
40 Participants
n=39 Participants
|
41 Participants
n=41 Participants
|
81 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age Continuous
|
10.4 years
STANDARD_DEVIATION 3.5 • n=39 Participants
|
10.7 years
STANDARD_DEVIATION 3.3 • n=41 Participants
|
10.6 years
STANDARD_DEVIATION 3.4 • n=35 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=39 Participants
|
16 Participants
n=41 Participants
|
30 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=39 Participants
|
25 Participants
n=41 Participants
|
51 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=39 Participants
|
41 participants
n=41 Participants
|
81 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: During hospitalizationstandard intention to treat (ITT) analysis
Outcome measures
| Measure |
Continuous Levalbuterol (R) Nebulized Solution
n=40 Participants
Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
|
Continuous Racemic (R+S) Albuterol
n=41 Participants
Continuous racemic albuterol 20mg/hr given as continuous nebulization
|
|---|---|---|
|
Duration of Continuous Therapy
|
18.3 Hours
Interval 11.0 to 25.0
|
16 Hours
Interval 11.0 to 25.0
|
SECONDARY outcome
Timeframe: After 12 hours of continuous nebulizationChange in Pediatric Asthma Severity Score. Range 0 (best) - 6 (worst) Score at each time point is calculated by adding 3 elements: Wheeze (0= None/Mild, 1=Moderate, 2=Severe) Prolonged expiration (0= None/Mild, 1=Moderate, 2=Severe) Work of breathing (0= None/Mild, 1=Moderate, 2=Severe)
Outcome measures
| Measure |
Continuous Levalbuterol (R) Nebulized Solution
n=40 Participants
Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
|
Continuous Racemic (R+S) Albuterol
n=41 Participants
Continuous racemic albuterol 20mg/hr given as continuous nebulization
|
|---|---|---|
|
Change in Pediatric Asthma Severity Score
|
-1.0 units on a scale
Standard Deviation 1.2
|
-0.64 units on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: After 12 hours of continuous nebulizationOutcome measures
| Measure |
Continuous Levalbuterol (R) Nebulized Solution
n=40 Participants
Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
|
Continuous Racemic (R+S) Albuterol
n=41 Participants
Continuous racemic albuterol 20mg/hr given as continuous nebulization
|
|---|---|---|
|
Heart Rate
|
132 beats per minute
Standard Deviation 16.4
|
132 beats per minute
Standard Deviation 18.4
|
SECONDARY outcome
Timeframe: After 12 hours of continuous nebulizationOutcome measures
| Measure |
Continuous Levalbuterol (R) Nebulized Solution
n=40 Participants
Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
|
Continuous Racemic (R+S) Albuterol
n=41 Participants
Continuous racemic albuterol 20mg/hr given as continuous nebulization
|
|---|---|---|
|
Serum Potassium Levels
|
3.6 mg/dL
Standard Deviation 0.6
|
3.6 mg/dL
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: After 6 hours of continuous albuterolOutcome measures
| Measure |
Continuous Levalbuterol (R) Nebulized Solution
n=40 Participants
Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
|
Continuous Racemic (R+S) Albuterol
n=41 Participants
Continuous racemic albuterol 20mg/hr given as continuous nebulization
|
|---|---|---|
|
Serum Albuterol S Isomer Levels
|
5.5 ng/mL
Standard Deviation 3.3
|
28.6 ng/mL
Standard Deviation 11.7
|
Adverse Events
Continuous Levalbuterol (R) Nebulized Solution
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Continuous Racemic (R+S) Albuterol
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place