Trial Outcomes & Findings for A Safety, Efficacy and Tolerability Study in Pediatric Subjects With Asthma (NCT NCT00809757)
NCT ID: NCT00809757
Last Updated: 2014-07-28
Results Overview
The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms). The mean daily composite score at Visit 4 is defined as the mean of the daily composite scores in the week prior to Visit 4.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
197 participants
Primary outcome timeframe
Baseline, Visit 4 (Week 4)
Results posted on
2014-07-28
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo: Placebo (2 actuations)
|
Levalbuterol MDI
90 ug Levalbuterol (2 actuations)
Levalbuterol: 90 ug Levalbuterol (2 actuations)
|
Levalbuterol UDV
0.31 ug Levalbuterol UDV TID
Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
|
|---|---|---|---|
|
Overall Study
STARTED
|
68
|
65
|
64
|
|
Overall Study
COMPLETED
|
62
|
60
|
53
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
11
|
Reasons for withdrawal
| Measure |
Placebo
Placebo: Placebo (2 actuations)
|
Levalbuterol MDI
90 ug Levalbuterol (2 actuations)
Levalbuterol: 90 ug Levalbuterol (2 actuations)
|
Levalbuterol UDV
0.31 ug Levalbuterol UDV TID
Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
3
|
|
Overall Study
Subject Uncooperative
|
1
|
0
|
2
|
|
Overall Study
Noncompliance with Medication
|
0
|
0
|
1
|
Baseline Characteristics
A Safety, Efficacy and Tolerability Study in Pediatric Subjects With Asthma
Baseline characteristics by cohort
| Measure |
Placebo
n=68 Participants
Placebo Placebo MDI TID
|
Levalbuterol MDI
n=65 Participants
Levalbuterol MDI TID
|
Levalbuterol UDV
n=63 Participants
Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
|
Total
n=196 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
68 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
196 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
29.2 Months
STANDARD_DEVIATION 12.17 • n=5 Participants
|
29.3 Months
STANDARD_DEVIATION 12.57 • n=7 Participants
|
28.4 Months
STANDARD_DEVIATION 12.48 • n=5 Participants
|
29.0 Months
STANDARD_DEVIATION 12.35 • n=4 Participants
|
|
Age, Customized
0 to < 12 months
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
9 participants
n=5 Participants
|
27 participants
n=4 Participants
|
|
Age, Customized
0 to < 24 months
|
23 participants
n=5 Participants
|
23 participants
n=7 Participants
|
22 participants
n=5 Participants
|
68 participants
n=4 Participants
|
|
Age, Customized
24 to < 48 months
|
45 participants
n=5 Participants
|
42 participants
n=7 Participants
|
41 participants
n=5 Participants
|
128 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
88 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
108 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
140 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
121 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
68 participants
n=5 Participants
|
65 participants
n=7 Participants
|
63 participants
n=5 Participants
|
196 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Visit 4 (Week 4)Population: Intent-to-Treat Population. Only those subjects who had non-missing data at Week 4 and at Baseline were included. Subjects who discontinued from the study prior to Week 4 are not included in this analysis
The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms). The mean daily composite score at Visit 4 is defined as the mean of the daily composite scores in the week prior to Visit 4.
Outcome measures
| Measure |
Placebo
n=62 Participants
Placebo: Placebo (2 actuations)
|
Levalbuterol MDI
n=59 Participants
90 ug Levalbuterol (2 actuations)
Levalbuterol: 90 ug Levalbuterol (2 actuations)
|
Levalbuterol UDV
n=54 Participants
0.31 ug Levalbuterol UDV TID
Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
|
|---|---|---|---|
|
Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessments (PACA)
|
-1.21 units on a scale
Standard Deviation 2.722
|
-0.67 units on a scale
Standard Deviation 2.092
|
-0.52 units on a scale
Standard Deviation 2.843
|
SECONDARY outcome
Timeframe: Baseline, Visit 3 (Week 3)Population: Intent-to-Treat Population
The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms). The mean daily composite score at Visit 3 is defined as the mean of the daily composite scores in the 7 days prior to Visit 3.
Outcome measures
| Measure |
Placebo
n=65 Participants
Placebo: Placebo (2 actuations)
|
Levalbuterol MDI
n=63 Participants
90 ug Levalbuterol (2 actuations)
Levalbuterol: 90 ug Levalbuterol (2 actuations)
|
Levalbuterol UDV
n=56 Participants
0.31 ug Levalbuterol UDV TID
Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
|
|---|---|---|---|
|
Change From Baseline to Visit 3 in Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment
|
-0.83 units on a scale
Standard Deviation 2.913
|
-0.28 units on a scale
Standard Deviation 2.490
|
-0.22 units on a scale
Standard Deviation 2.545
|
SECONDARY outcome
Timeframe: The days from Visit 2 (inclusive) to the day prior to Visit 3 - approximately 14 daysPopulation: Intent-to-Treat Population
The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms). The mean daily composite score from Visit 2 to Visit 3 is defined as the mean of the daily composite scores from Visit 2 (inclusive) to the day prior to Visit 3.
Outcome measures
| Measure |
Placebo
n=68 Participants
Placebo: Placebo (2 actuations)
|
Levalbuterol MDI
n=64 Participants
90 ug Levalbuterol (2 actuations)
Levalbuterol: 90 ug Levalbuterol (2 actuations)
|
Levalbuterol UDV
n=59 Participants
0.31 ug Levalbuterol UDV TID
Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
|
|---|---|---|---|
|
Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment
|
-0.82 units on a scale
Standard Deviation 2.417
|
-0.25 units on a scale
Standard Deviation 2.041
|
-0.15 units on a scale
Standard Deviation 2.067
|
SECONDARY outcome
Timeframe: The days from Visit 3 (inclusive) to the day prior to Visit 4 - approximately 14 daysPopulation: Intent-to-Treat Population
The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms). The mean daily composite score from Visit 3 to Visit 4 is defined as the mean of the daily composite scores from Visit 3 (inclusive) to the day prior to Visit 4.
Outcome measures
| Measure |
Placebo
n=64 Participants
Placebo: Placebo (2 actuations)
|
Levalbuterol MDI
n=62 Participants
90 ug Levalbuterol (2 actuations)
Levalbuterol: 90 ug Levalbuterol (2 actuations)
|
Levalbuterol UDV
n=57 Participants
0.31 ug Levalbuterol UDV TID
Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
|
|---|---|---|---|
|
Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment
|
-1.08 units on a scale
Standard Deviation 2.478
|
-0.40 units on a scale
Standard Deviation 2.285
|
-0.52 units on a scale
Standard Deviation 2.331
|
SECONDARY outcome
Timeframe: Baseline, Visit 3 (Week 3)Population: Intent-to-Treat Population
The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms). The mean daily composite score at Visit 3 is defined as the mean daily composite scores for 7 days prior to Visit 3.
Outcome measures
| Measure |
Placebo
n=65 Participants
Placebo: Placebo (2 actuations)
|
Levalbuterol MDI
n=63 Participants
90 ug Levalbuterol (2 actuations)
Levalbuterol: 90 ug Levalbuterol (2 actuations)
|
Levalbuterol UDV
n=56 Participants
0.31 ug Levalbuterol UDV TID
Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
|
|---|---|---|---|
|
Change From Baseline to Visit 3 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by the Pediatric Asthma Questionnaire (PAQ)
|
-0.82 units on a scale
Standard Deviation 3.457
|
-0.45 units on a scale
Standard Deviation 3.522
|
0.00 units on a scale
Standard Deviation 3.199
|
SECONDARY outcome
Timeframe: Baseline, Visit 4 (Week 4)Population: Intent-to-Treat Population
The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms). The mean daily composite score at Visit 4 is defined as the mean daily composite scores in the 7 days prior to Visit 4.
Outcome measures
| Measure |
Placebo
n=62 Participants
Placebo: Placebo (2 actuations)
|
Levalbuterol MDI
n=59 Participants
90 ug Levalbuterol (2 actuations)
Levalbuterol: 90 ug Levalbuterol (2 actuations)
|
Levalbuterol UDV
n=54 Participants
0.31 ug Levalbuterol UDV TID
Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
|
|---|---|---|---|
|
Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by Pediatric Asthma Questionnaire
|
-1.39 units on a scale
Standard Deviation 3.213
|
-0.91 units on a scale
Standard Deviation 2.585
|
-0.47 units on a scale
Standard Deviation 2.931
|
SECONDARY outcome
Timeframe: The days from Visit 2 (inclusive) to the day prior to Visit 3 - approximately 14 daysPopulation: Intent-to-Treat Population
The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms). The mean daily composite score from Visit 2 to Visit 3 is defined as the mean of the daily composite scores from Visit 2 (inclusive) to the day prior to Visit 3.
Outcome measures
| Measure |
Placebo
n=68 Participants
Placebo: Placebo (2 actuations)
|
Levalbuterol MDI
n=65 Participants
90 ug Levalbuterol (2 actuations)
Levalbuterol: 90 ug Levalbuterol (2 actuations)
|
Levalbuterol UDV
n=59 Participants
0.31 ug Levalbuterol UDV TID
Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
|
|---|---|---|---|
|
Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by the Pediatric Asthma Questionnaire
|
-0.87 units on a scale
Standard Deviation 2.797
|
-0.36 units on a scale
Standard Deviation 2.872
|
-0.08 units on a scale
Standard Deviation 2.589
|
SECONDARY outcome
Timeframe: The days from Visit 3 (inclusive) to the day prior to Visit 4 - approximately 14 daysPopulation: Intent-to-Treat Population
The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms). The mean daily composite score from Visit 3 to Visit 4 is defined as the mean of the daily composite scores from Visit 3 (inclusive) to the day prior to Visit 4.
Outcome measures
| Measure |
Placebo
n=64 Participants
Placebo: Placebo (2 actuations)
|
Levalbuterol MDI
n=62 Participants
90 ug Levalbuterol (2 actuations)
Levalbuterol: 90 ug Levalbuterol (2 actuations)
|
Levalbuterol UDV
n=57 Participants
0.31 ug Levalbuterol UDV TID
Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
|
|---|---|---|---|
|
Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Score as Measured by the Pediatric Asthma Questionnaire
|
-1.24 units on a scale
Standard Deviation 2.979
|
-0.61 units on a scale
Standard Deviation 2.706
|
-0.37 units on a scale
Standard Deviation 2.572
|
SECONDARY outcome
Timeframe: Baseline, Visit 2: 30 minutes post-dose (on the day of randomization), 1 hour post-dose, 4 hours post-dose, 6 hours post-dosePopulation: Intent-to-Treat Population - PEF Cohort (Subjects able to perform PEFs)
Peak expiratory flow (PEF) measures how fast a person can breathe out using the greatest effort
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo: Placebo (2 actuations)
|
Levalbuterol MDI
n=8 Participants
90 ug Levalbuterol (2 actuations)
Levalbuterol: 90 ug Levalbuterol (2 actuations)
|
Levalbuterol UDV
n=8 Participants
0.31 ug Levalbuterol UDV TID
Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
|
|---|---|---|---|
|
Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2
Visit 2, 30 minutes post-dose
|
-0.08 liters
Standard Deviation 0.147
|
0.17 liters
Standard Deviation 0.211
|
0.16 liters
Standard Deviation 0.101
|
|
Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2
Visit 2, 1 hour post-dose
|
-0.04 liters
Standard Deviation 0.183
|
0.13 liters
Standard Deviation 0.162
|
0.18 liters
Standard Deviation 0.176
|
|
Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2
Visit 2, 4 hours post-dose
|
-0.09 liters
Standard Deviation 0.303
|
0.06 liters
Standard Deviation 0.098
|
0.04 liters
Standard Deviation 0.188
|
|
Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2
Visit 2, 6 hours post-dose
|
-0.07 liters
Standard Deviation 0.121
|
0.12 liters
Standard Deviation 0.164
|
0.06 liters
Standard Deviation 0.213
|
SECONDARY outcome
Timeframe: Baseline, Visit 3, pre-dose (approximately 14 days after randomization)Population: Intent-to-Treat Population - PEF Cohort (Subjects able to perform PEFs)
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo: Placebo (2 actuations)
|
Levalbuterol MDI
n=7 Participants
90 ug Levalbuterol (2 actuations)
Levalbuterol: 90 ug Levalbuterol (2 actuations)
|
Levalbuterol UDV
n=8 Participants
0.31 ug Levalbuterol UDV TID
Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
|
|---|---|---|---|
|
Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 3
|
-0.23 liters
Standard Deviation 0.255
|
0.14 liters
Standard Deviation 0.251
|
0.03 liters
Standard Deviation 0.120
|
SECONDARY outcome
Timeframe: Visit 4: pre-dose (approximately 28 days after randomization) , 30 minutes post-dose, 1 hour post-dose, 4 hours post-dose, 6 hours post-dosePopulation: Intent-to-Treat Population - PEF Cohort (Subjects able to perform PEFs)
Outcome measures
| Measure |
Placebo
n=10 Participants
Placebo: Placebo (2 actuations)
|
Levalbuterol MDI
n=7 Participants
90 ug Levalbuterol (2 actuations)
Levalbuterol: 90 ug Levalbuterol (2 actuations)
|
Levalbuterol UDV
n=8 Participants
0.31 ug Levalbuterol UDV TID
Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
|
|---|---|---|---|
|
Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 4
Visit 4, 6 hours post-dose
|
-0.07 liters
Standard Deviation 0.260
|
0.20 liters
Standard Deviation 0.173
|
0.09 liters
Standard Deviation 0.361
|
|
Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 4
Visit 4, pre-dose
|
-0.25 liters
Standard Deviation 0.307
|
0.29 liters
Standard Deviation 0.313
|
0.04 liters
Standard Deviation 0.146
|
|
Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 4
Visit 4, 30 minutes post-dose
|
-0.17 liters
Standard Deviation 0.323
|
0.29 liters
Standard Deviation 0.247
|
0.42 liters
Standard Deviation 0.585
|
|
Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 4
Visit 4, 1 hour post-dose
|
-0.03 liters
Standard Deviation 0.332
|
0.40 liters
Standard Deviation 0.242
|
0.16 liters
Standard Deviation 0.227
|
|
Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 4
Visit 4, 4 hours post-dose
|
-0.11 liters
Standard Deviation 0.382
|
0.30 liters
Standard Deviation 0.305
|
0.11 liters
Standard Deviation 0.181
|
SECONDARY outcome
Timeframe: Baseline, Visit 2: , 30 minutes post-dose (on the day of randomization), 1 hour post-dose, 4 hours post-dose, 6 hours post-dosePopulation: Intent-to-Treat Population - PEF Cohort (Subjects able to perform PEFs)
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo: Placebo (2 actuations)
|
Levalbuterol MDI
n=8 Participants
90 ug Levalbuterol (2 actuations)
Levalbuterol: 90 ug Levalbuterol (2 actuations)
|
Levalbuterol UDV
n=8 Participants
0.31 ug Levalbuterol UDV TID
Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
|
|---|---|---|---|
|
Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2
Visit 2, 30 minutes post-does
|
-5.42 percent change
Standard Deviation 9.940
|
23.22 percent change
Standard Deviation 36.195
|
21.71 percent change
Standard Deviation 23.782
|
|
Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2
Visit 2, 1 hour post-dose
|
-2.83 percent change
Standard Deviation 15.094
|
18.21 percent change
Standard Deviation 26.225
|
25.05 percent change
Standard Deviation 37.207
|
|
Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2
Visit 2, 4 hours post-dose
|
-4.22 percent change
Standard Deviation 17.886
|
9.54 percent change
Standard Deviation 15.467
|
11.74 percent change
Standard Deviation 37.114
|
|
Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2
Visit 2, 6 hours post-dose
|
-5.24 percent change
Standard Deviation 10.440
|
17.21 percent change
Standard Deviation 24.013
|
14.40 percent change
Standard Deviation 41.548
|
SECONDARY outcome
Timeframe: Baseline, Visit 3, pre -dose (approximately 14 days after randomization)Population: Intent-to-Treat Population - PEF Cohort (Subjects able to perform PEFs)
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo: Placebo (2 actuations)
|
Levalbuterol MDI
n=7 Participants
90 ug Levalbuterol (2 actuations)
Levalbuterol: 90 ug Levalbuterol (2 actuations)
|
Levalbuterol UDV
n=8 Participants
0.31 ug Levalbuterol UDV TID
Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
|
|---|---|---|---|
|
Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 3
|
-18.58 percent change
Standard Deviation 21.742
|
25.36 percent change
Standard Deviation 30.129
|
6.02 percent change
Standard Deviation 13.444
|
SECONDARY outcome
Timeframe: Baseline, Visit 4, pre -dose (approximately 28 days after randomization)Population: Intent-to-Treat Population - PEF Cohort (Subjects able to perform PEFs)
Outcome measures
| Measure |
Placebo
n=10 Participants
Placebo: Placebo (2 actuations)
|
Levalbuterol MDI
n=7 Participants
90 ug Levalbuterol (2 actuations)
Levalbuterol: 90 ug Levalbuterol (2 actuations)
|
Levalbuterol UDV
n=8 Participants
0.31 ug Levalbuterol UDV TID
Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
|
|---|---|---|---|
|
Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 4
Visit 4, 30 minutes post-dose
|
-11.69 percent change
Standard Deviation 27.617
|
48.94 percent change
Standard Deviation 48.881
|
47.47 percent change
Standard Deviation 55.010
|
|
Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 4
Visit 4, pre-dose
|
-17.26 percent change
Standard Deviation 23.343
|
49.92 percent change
Standard Deviation 48.545
|
7.03 percent change
Standard Deviation 18.829
|
|
Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 4
Visit 4, 1 hour post-dose
|
0.94 percent change
Standard Deviation 24.020
|
63.76 percent change
Standard Deviation 45.620
|
25.32 percent change
Standard Deviation 47.769
|
|
Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 4
Visit 4, 4 hours post-dose
|
-4.67 percent change
Standard Deviation 27.435
|
47.59 percent change
Standard Deviation 42.339
|
20.20 percent change
Standard Deviation 37.895
|
|
Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 4
Visit 4, 6 hours post-dose
|
-2.06 percent change
Standard Deviation 21.507
|
32.00 percent change
Standard Deviation 27.657
|
25.09 percent change
Standard Deviation 69.440
|
SECONDARY outcome
Timeframe: Baseline, Visit 3 (the week prior to Visit 3) and Visit 4Population: Intent-to-Treat Population - PEF Cohort (Subjects able to perform PEFs)
Mean of the daily pre-dose PEF values in the week prior to visit in those subjects aged 24 to \<48 months capable of performing acceptable and reproducible PEF maneuvers.
Outcome measures
| Measure |
Placebo
n=10 Participants
Placebo: Placebo (2 actuations)
|
Levalbuterol MDI
n=8 Participants
90 ug Levalbuterol (2 actuations)
Levalbuterol: 90 ug Levalbuterol (2 actuations)
|
Levalbuterol UDV
n=8 Participants
0.31 ug Levalbuterol UDV TID
Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
|
|---|---|---|---|
|
Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4
Visit 3
|
0.07 liters
Standard Deviation 0.164
|
0.12 liters
Standard Deviation 0.209
|
0.01 liters
Standard Deviation 0.193
|
|
Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4
Visit 4
|
0.00 liters
Standard Deviation 0.205
|
0.08 liters
Standard Deviation 0.186
|
-0.01 liters
Standard Deviation 0.096
|
SECONDARY outcome
Timeframe: Visit 3 (the week prior to Visit 3), Visit 4 (the week prior to Visit 4)Population: Intent-to-Treat Population - PEF Cohort (Subjects able to perform PEFs)
Mean of the daily pre-dose PEF values in the week prior to visit in those subjects aged 24 to \<48 months capable of performing acceptable and reproducible PEF maneuvers.
Outcome measures
| Measure |
Placebo
n=10 Participants
Placebo: Placebo (2 actuations)
|
Levalbuterol MDI
n=8 Participants
90 ug Levalbuterol (2 actuations)
Levalbuterol: 90 ug Levalbuterol (2 actuations)
|
Levalbuterol UDV
n=8 Participants
0.31 ug Levalbuterol UDV TID
Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
|
|---|---|---|---|
|
Percent Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4)
Visit 3
|
7.39 percent change
Standard Deviation 16.585
|
15.05 percent change
Standard Deviation 26.849
|
5.30 percent change
Standard Deviation 21.093
|
|
Percent Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4)
Visit 4
|
0.21 percent change
Standard Deviation 22.426
|
10.33 percent change
Standard Deviation 24.436
|
-1.05 percent change
Standard Deviation 12.155
|
SECONDARY outcome
Timeframe: Visit 4 (End of 28 day treatment period)Population: Intent-to-Treat Population
Since the start of the study, how would you evaluate the child's asthma symptoms?
Outcome measures
| Measure |
Placebo
n=62 Participants
Placebo: Placebo (2 actuations)
|
Levalbuterol MDI
n=60 Participants
90 ug Levalbuterol (2 actuations)
Levalbuterol: 90 ug Levalbuterol (2 actuations)
|
Levalbuterol UDV
n=55 Participants
0.31 ug Levalbuterol UDV TID
Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
|
|---|---|---|---|
|
Investigator Global Assessment - Question 1
Much Worse
|
0 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
|
Investigator Global Assessment - Question 1
Much Better
|
12 Number of subjects
|
17 Number of subjects
|
16 Number of subjects
|
|
Investigator Global Assessment - Question 1
Moderately Better
|
23 Number of subjects
|
15 Number of subjects
|
13 Number of subjects
|
|
Investigator Global Assessment - Question 1
Slightly Better
|
12 Number of subjects
|
14 Number of subjects
|
11 Number of subjects
|
|
Investigator Global Assessment - Question 1
The Same
|
14 Number of subjects
|
12 Number of subjects
|
13 Number of subjects
|
|
Investigator Global Assessment - Question 1
Slightly Worse
|
0 Number of subjects
|
1 Number of subjects
|
1 Number of subjects
|
|
Investigator Global Assessment - Question 1
Moderately Worse
|
1 Number of subjects
|
1 Number of subjects
|
1 Number of subjects
|
SECONDARY outcome
Timeframe: Visit 4 (End of 28 day treatment period)Population: Intent-to-Treat Population
Since the start of the study, how would you evaluate your ability to manage the subject's asthma?
Outcome measures
| Measure |
Placebo
n=62 Participants
Placebo: Placebo (2 actuations)
|
Levalbuterol MDI
n=60 Participants
90 ug Levalbuterol (2 actuations)
Levalbuterol: 90 ug Levalbuterol (2 actuations)
|
Levalbuterol UDV
n=55 Participants
0.31 ug Levalbuterol UDV TID
Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
|
|---|---|---|---|
|
Investigator Global Assessment - Question 2
Moderately Better
|
17 Number of subjects
|
12 Number of subjects
|
11 Number of subjects
|
|
Investigator Global Assessment - Question 2
Slightly Better
|
8 Number of subjects
|
12 Number of subjects
|
7 Number of subjects
|
|
Investigator Global Assessment - Question 2
The Same
|
17 Number of subjects
|
15 Number of subjects
|
14 Number of subjects
|
|
Investigator Global Assessment - Question 2
Slightly Worse
|
0 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
|
Investigator Global Assessment - Question 2
Moderately Worse
|
1 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
|
Investigator Global Assessment - Question 2
Much Worse
|
0 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
|
Investigator Global Assessment - Question 2
Much Better
|
19 Number of subjects
|
21 Number of subjects
|
23 Number of subjects
|
SECONDARY outcome
Timeframe: Visit 4 (End of 28 day treatment period)Population: Intent-to-Treat Population
Since the start of the study, how would you evaluate your child's asthma symptoms?
Outcome measures
| Measure |
Placebo
n=62 Participants
Placebo: Placebo (2 actuations)
|
Levalbuterol MDI
n=60 Participants
90 ug Levalbuterol (2 actuations)
Levalbuterol: 90 ug Levalbuterol (2 actuations)
|
Levalbuterol UDV
n=55 Participants
0.31 ug Levalbuterol UDV TID
Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
|
|---|---|---|---|
|
Caregiver Global Assessment - Question 1
Much Better
|
21 Number of subjects
|
21 Number of subjects
|
21 Number of subjects
|
|
Caregiver Global Assessment - Question 1
Moderately Better
|
16 Number of subjects
|
14 Number of subjects
|
13 Number of subjects
|
|
Caregiver Global Assessment - Question 1
Slightly Better
|
12 Number of subjects
|
12 Number of subjects
|
8 Number of subjects
|
|
Caregiver Global Assessment - Question 1
The Same
|
12 Number of subjects
|
11 Number of subjects
|
12 Number of subjects
|
|
Caregiver Global Assessment - Question 1
Slightly Worse
|
1 Number of subjects
|
2 Number of subjects
|
0 Number of subjects
|
|
Caregiver Global Assessment - Question 1
Moderately Worse
|
0 Number of subjects
|
0 Number of subjects
|
1 Number of subjects
|
|
Caregiver Global Assessment - Question 1
Much Worse
|
0 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
SECONDARY outcome
Timeframe: Visit 4 (End of 28 day treatment period)Population: Intent-to-Treat Population
Since the start of the study, how would you evaluate your ability to manage your child's asthma?
Outcome measures
| Measure |
Placebo
n=62 Participants
Placebo: Placebo (2 actuations)
|
Levalbuterol MDI
n=60 Participants
90 ug Levalbuterol (2 actuations)
Levalbuterol: 90 ug Levalbuterol (2 actuations)
|
Levalbuterol UDV
n=55 Participants
0.31 ug Levalbuterol UDV TID
Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
|
|---|---|---|---|
|
Caregiver Global Assessment - Question 2
Slightly Worse
|
1 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
|
Caregiver Global Assessment - Question 2
Much Better
|
27 Number of subjects
|
32 Number of subjects
|
29 Number of subjects
|
|
Caregiver Global Assessment - Question 2
Moderately Better
|
12 Number of subjects
|
6 Number of subjects
|
10 Number of subjects
|
|
Caregiver Global Assessment - Question 2
Slightly Better
|
11 Number of subjects
|
10 Number of subjects
|
4 Number of subjects
|
|
Caregiver Global Assessment - Question 2
The Same
|
11 Number of subjects
|
12 Number of subjects
|
12 Number of subjects
|
|
Caregiver Global Assessment - Question 2
Moderately Worse
|
0 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
|
Caregiver Global Assessment - Question 2
Much Worse
|
0 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
SECONDARY outcome
Timeframe: Visit 4 (End of 28 day treatment period)Population: Intent-to-Treat Population
Overall I was: Very satisfied with the control of the child's asthma symptoms while enrolled in this study, Moderately satisfied with the control of the child's asthma symptoms while enrolled in this study, Slightly satisfied with the control of the child's asthma symptoms while enrolled in this study, Not satisfied with the control of the child's asthma symptoms while enrolled in this study or answer Missing
Outcome measures
| Measure |
Placebo
n=62 Participants
Placebo: Placebo (2 actuations)
|
Levalbuterol MDI
n=60 Participants
90 ug Levalbuterol (2 actuations)
Levalbuterol: 90 ug Levalbuterol (2 actuations)
|
Levalbuterol UDV
n=55 Participants
0.31 ug Levalbuterol UDV TID
Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
|
|---|---|---|---|
|
Caregiver Global Assessment - Question 3
Very satisfied
|
47 Number of subjects
|
45 Number of subjects
|
45 Number of subjects
|
|
Caregiver Global Assessment - Question 3
Moderately satisfied
|
11 Number of subjects
|
12 Number of subjects
|
7 Number of subjects
|
|
Caregiver Global Assessment - Question 3
Slightly satisfied
|
4 Number of subjects
|
2 Number of subjects
|
1 Number of subjects
|
|
Caregiver Global Assessment - Question 3
Not satisfied
|
0 Number of subjects
|
1 Number of subjects
|
2 Number of subjects
|
SECONDARY outcome
Timeframe: Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)Population: Intent-to-Treat Population
Number of subjects using rescue medication during the treatment period
Outcome measures
| Measure |
Placebo
n=68 Participants
Placebo: Placebo (2 actuations)
|
Levalbuterol MDI
n=65 Participants
90 ug Levalbuterol (2 actuations)
Levalbuterol: 90 ug Levalbuterol (2 actuations)
|
Levalbuterol UDV
n=63 Participants
0.31 ug Levalbuterol UDV TID
Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
|
|---|---|---|---|
|
Rescue Medication Use: Number of Subjects Using Rescue Medication During the Treatment Period
Visit 2 to Visit 3 the first 2 weeks of the study
|
24 Number of subjects
|
20 Number of subjects
|
14 Number of subjects
|
|
Rescue Medication Use: Number of Subjects Using Rescue Medication During the Treatment Period
Visit 3 to Visit 4 the second 2 weeks of the study
|
20 Number of subjects
|
20 Number of subjects
|
12 Number of subjects
|
|
Rescue Medication Use: Number of Subjects Using Rescue Medication During the Treatment Period
Visit 2 to Visit 4 the entire 4 weeks of the study
|
33 Number of subjects
|
29 Number of subjects
|
20 Number of subjects
|
SECONDARY outcome
Timeframe: Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)Population: Intent-to-Treat Population - Subjects who used rescue medication at any time during the first two weeks of the study and who used rescue medication at any time during baseline
Outcome measures
| Measure |
Placebo
n=10 Participants
Placebo: Placebo (2 actuations)
|
Levalbuterol MDI
n=11 Participants
90 ug Levalbuterol (2 actuations)
Levalbuterol: 90 ug Levalbuterol (2 actuations)
|
Levalbuterol UDV
n=3 Participants
0.31 ug Levalbuterol UDV TID
Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
|
|---|---|---|---|
|
Rescue Medication Use - Change From Baseline in Mean Number of Days Used Per Week When Used
Visit 2 to Visit 3 the first 2 weeks of the study
|
-0.3 Days per Week
Standard Deviation 2.43
|
-0.8 Days per Week
Standard Deviation 2.22
|
-1.3 Days per Week
Standard Deviation 1.29
|
|
Rescue Medication Use - Change From Baseline in Mean Number of Days Used Per Week When Used
Visit 3 to Visit 4 the second 2 weeks of the study
|
-0.8 Days per Week
Standard Deviation 1.51
|
0.1 Days per Week
Standard Deviation 2.57
|
-1.0 Days per Week
Standard Deviation 0.94
|
|
Rescue Medication Use - Change From Baseline in Mean Number of Days Used Per Week When Used
Visit 2 to Visit 4 the entire 4 weeks of the study
|
-1.1 Days per Week
Standard Deviation 1.95
|
-0.5 Days per Week
Standard Deviation 1.89
|
-1.1 Days per Week
Standard Deviation 0.73
|
SECONDARY outcome
Timeframe: Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)Population: Intent-to-Treat Population
Outcome measures
| Measure |
Placebo
n=68 Participants
Placebo: Placebo (2 actuations)
|
Levalbuterol MDI
n=65 Participants
90 ug Levalbuterol (2 actuations)
Levalbuterol: 90 ug Levalbuterol (2 actuations)
|
Levalbuterol UDV
n=63 Participants
0.31 ug Levalbuterol UDV TID
Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
|
|---|---|---|---|
|
Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week
Visit 2 to Visit 3 the first 2 weeks of the study
|
0.0 Doses per Week
Standard Deviation 3.14
|
0.1 Doses per Week
Standard Deviation 2.77
|
0.0 Doses per Week
Standard Deviation 0.77
|
|
Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week
Visit 3 to Visit 4 the second 2 weeks of the study
|
-0.4 Doses per Week
Standard Deviation 3.56
|
0.4 Doses per Week
Standard Deviation 2.83
|
0.1 Doses per Week
Standard Deviation 1.28
|
|
Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week
Visit 2 to Visit 4 the entire 4 weeks of the study
|
-0.2 Doses per Week
Standard Deviation 3.10
|
0.3 Doses per Week
Standard Deviation 2.23
|
0.0 Doses per Week
Standard Deviation 0.96
|
SECONDARY outcome
Timeframe: Visit 2 to Visit 3 (the first 2 weeks of the study), Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)Population: Intent-to-Treat Population - subjects who used rescue medication at any time during the first 2 weeks of the study and who had used rescue medication at any time during baseline
Outcome measures
| Measure |
Placebo
n=10 Participants
Placebo: Placebo (2 actuations)
|
Levalbuterol MDI
n=11 Participants
90 ug Levalbuterol (2 actuations)
Levalbuterol: 90 ug Levalbuterol (2 actuations)
|
Levalbuterol UDV
n=3 Participants
0.31 ug Levalbuterol UDV TID
Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
|
|---|---|---|---|
|
Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week During Weeks When Used
Visit 2 to Visit 3 the first 2 weeks of the study
|
-2.1 Doses per Week
Standard Deviation 8.84
|
-0.6 Doses per Week
Standard Deviation 3.94
|
-1.3 Doses per Week
Standard Deviation 2.08
|
|
Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week During Weeks When Used
Visit 3 to Visit 4 the second 2 weeks of the study
|
-2.9 Doses per Week
Standard Deviation 7.64
|
2.8 Doses per Week
Standard Deviation 6.27
|
-0.8 Doses per Week
Standard Deviation 1.44
|
|
Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week During Weeks When Used
Visit 2 to Visit 4 the entire 4 weeks of the study
|
-2.1 Doses per Week
Standard Deviation 8.06
|
1.8 Doses per Week
Standard Deviation 4.75
|
-0.8 Doses per Week
Standard Deviation 1.56
|
SECONDARY outcome
Timeframe: Visit 3 and Visit 4 (End of 28 day treatment period)Population: Intent-to-Treat Population
The PACQLQ composite score was calculated as the mean of the scores of the 13 individual questions. Composite scores could range from 1 to 7. Lower scores indicated greater impact of disease on quality of life.
Outcome measures
| Measure |
Placebo
n=62 Participants
Placebo: Placebo (2 actuations)
|
Levalbuterol MDI
n=60 Participants
90 ug Levalbuterol (2 actuations)
Levalbuterol: 90 ug Levalbuterol (2 actuations)
|
Levalbuterol UDV
n=55 Participants
0.31 ug Levalbuterol UDV TID
Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
|
|---|---|---|---|
|
Change From Baseline to Visit 3 and Visit 4 in the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLA) Composite Score
Visit 3
|
0.34 Units on a scale
Standard Deviation 0.888
|
0.35 Units on a scale
Standard Deviation 0.976
|
0.18 Units on a scale
Standard Deviation 0.944
|
|
Change From Baseline to Visit 3 and Visit 4 in the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLA) Composite Score
Visit 4
|
0.41 Units on a scale
Standard Deviation 0.931
|
0.44 Units on a scale
Standard Deviation 1.171
|
0.21 Units on a scale
Standard Deviation 0.883
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Levalbuterol MDI
Serious events: 1 serious events
Other events: 31 other events
Deaths: 0 deaths
Levalbuterol UDV
Serious events: 3 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=68 participants at risk
PBO MDI Placebo: Placebo (2 actuations) MDI TID
|
Levalbuterol MDI
n=65 participants at risk
LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
|
Levalbuterol UDV
n=63 participants at risk
LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
|
|---|---|---|---|
|
Infections and infestations
Metapneumovirus Infection
|
0.00%
0/68 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
1.5%
1/65 • Number of events 1 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
0.00%
0/63 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
|
Infections and infestations
Pneumonia
|
0.00%
0/68 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
0.00%
0/65 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
1.6%
1/63 • Number of events 1 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/68 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
0.00%
0/65 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
1.6%
1/63 • Number of events 1 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/68 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
0.00%
0/65 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
3.2%
2/63 • Number of events 2 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/68 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
1.5%
1/65 • Number of events 1 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
0.00%
0/63 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
|
Respiratory, thoracic and mediastinal disorders
Status Asthmaticus
|
0.00%
0/68 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
1.5%
1/65 • Number of events 1 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
0.00%
0/63 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
Other adverse events
| Measure |
Placebo
n=68 participants at risk
PBO MDI Placebo: Placebo (2 actuations) MDI TID
|
Levalbuterol MDI
n=65 participants at risk
LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
|
Levalbuterol UDV
n=63 participants at risk
LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/68 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
3.1%
2/65 • Number of events 2 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
0.00%
0/63 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
2/68 • Number of events 2 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
4.6%
3/65 • Number of events 3 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
3.2%
2/63 • Number of events 2 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
|
Infections and infestations
Nasopharyngitis
|
4.4%
3/68 • Number of events 3 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
1.5%
1/65 • Number of events 1 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
1.6%
1/63 • Number of events 1 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
|
Infections and infestations
Sinusitis
|
0.00%
0/68 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
3.1%
2/65 • Number of events 2 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
0.00%
0/63 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
|
Infections and infestations
Sinusitis Bacterial
|
1.5%
1/68 • Number of events 1 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
3.1%
2/65 • Number of events 2 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
0.00%
0/63 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
|
Infections and infestations
Tonsillitis
|
4.4%
3/68 • Number of events 3 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
0.00%
0/65 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
0.00%
0/63 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
|
Nervous system disorders
Headache
|
0.00%
0/68 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
4.6%
3/65 • Number of events 3 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
0.00%
0/63 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
|
Skin and subcutaneous tissue disorders
Dermatitis Diaper
|
1.5%
1/68 • Number of events 1 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
3.1%
2/65 • Number of events 2 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
0.00%
0/63 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/68 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
3.1%
2/65 • Number of events 2 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
0.00%
0/63 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
|
Gastrointestinal disorders
Diarrhoea
|
4.4%
3/68 • Number of events 4 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
9.2%
6/65 • Number of events 8 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
3.2%
2/63 • Number of events 2 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
|
General disorders
Pyrexia
|
8.8%
6/68 • Number of events 6 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
4.6%
3/65 • Number of events 3 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
11.1%
7/63 • Number of events 7 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
|
Infections and infestations
Otitis Media
|
7.4%
5/68 • Number of events 6 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
7.7%
5/65 • Number of events 6 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
12.7%
8/63 • Number of events 8 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.9%
4/68 • Number of events 4 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
7.7%
5/65 • Number of events 5 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
7.9%
5/63 • Number of events 5 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.4%
3/68 • Number of events 3 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
6.2%
4/65 • Number of events 4 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
3.2%
2/63 • Number of events 2 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.9%
2/68 • Number of events 2 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
6.2%
4/65 • Number of events 5 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
0.00%
0/63 • 4 weeks
One subject in the randomized to levalbuterol UDV group was not dosed
|
Additional Information
Respiratory Medical Director
Sunovion
Phone: 1-866-503-6351
Results disclosure agreements
- Principal investigator is a sponsor employee In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish
- Publication restrictions are in place
Restriction type: OTHER