Trial Outcomes & Findings for A Safety and Tolerability Study of Arformoterol Tartrate Inhalation Solution in Pediatric Subjects (NCT NCT00583947)
NCT ID: NCT00583947
Last Updated: 2012-02-22
Results Overview
Heart rate measured at various timepoints: predose and timepoints after each of the three dosings. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
predose, various timeframes up to 5 hours post last dose
Results posted on
2012-02-22
Participant Flow
86 subjects were screened: 23 subjects aged 2-5 years and 63 subjects aged 6-11 years.
Participant milestones
| Measure |
ARF/LEV
Cross-over period: one day active treatment with arformoterol 7.5 microgram per nebulization followed by a 7 day washout. Then a one day active treatment with levalbuterol 0.63 milligram per nebulization.
Open-label period: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization.
|
LEV/ARF
Cross-over period: one day active treatment with levalbuterol 0.63 milligram per nebulization followed by a 7 day washout. Then a one day active treatment with arformoterol 7.5 micrograms per nebulization.
Open-label period: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization.
|
|---|---|---|
|
Cross-over Period
STARTED
|
27
|
26
|
|
Cross-over Period
COMPLETED
|
22
|
24
|
|
Cross-over Period
NOT COMPLETED
|
5
|
2
|
|
Washout
STARTED
|
22
|
24
|
|
Washout
COMPLETED
|
22
|
24
|
|
Washout
NOT COMPLETED
|
0
|
0
|
|
Open Label Period
STARTED
|
22
|
24
|
|
Open Label Period
COMPLETED
|
22
|
24
|
|
Open Label Period
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
ARF/LEV
Cross-over period: one day active treatment with arformoterol 7.5 microgram per nebulization followed by a 7 day washout. Then a one day active treatment with levalbuterol 0.63 milligram per nebulization.
Open-label period: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization.
|
LEV/ARF
Cross-over period: one day active treatment with levalbuterol 0.63 milligram per nebulization followed by a 7 day washout. Then a one day active treatment with arformoterol 7.5 micrograms per nebulization.
Open-label period: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization.
|
|---|---|---|
|
Cross-over Period
Adverse Event
|
2
|
0
|
|
Cross-over Period
Withdrawal by Subject
|
2
|
0
|
|
Cross-over Period
Did not meet-no longer met entry criteri
|
0
|
1
|
|
Cross-over Period
Other
|
1
|
1
|
Baseline Characteristics
A Safety and Tolerability Study of Arformoterol Tartrate Inhalation Solution in Pediatric Subjects
Baseline characteristics by cohort
| Measure |
ARF/LEV
n=27 Participants
Cross-over: Participants treated with arformoterol 7.5 microgram per nebulization; 7 day washout; levalbuterol 0.63 milligram per nebulization.
Open label: 7 day washout; arformoterol 15 microgram per nebulization.
|
LEV/ARF
n=26 Participants
Cross-over: Participants treated with levalbuterol 0.63 milligram per nebulization; 7 day washout; arformoterol 7.5 microgram per nebulization.
Open label: 7 day washout; arformoterol 15 microgram per nebulization.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
27 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age Continuous
Age 2-5 years
|
4.4 years
STANDARD_DEVIATION 0.79 • n=99 Participants
|
4.4 years
STANDARD_DEVIATION 0.79 • n=107 Participants
|
4.4 years
STANDARD_DEVIATION 0.76 • n=206 Participants
|
|
Age Continuous
Age 6-11 years
|
9.0 years
STANDARD_DEVIATION 1.26 • n=99 Participants
|
8.5 years
STANDARD_DEVIATION 1.43 • n=107 Participants
|
8.8 years
STANDARD_DEVIATION 1.35 • n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
19 participants
n=99 Participants
|
12 participants
n=107 Participants
|
31 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
6 participants
n=99 Participants
|
14 participants
n=107 Participants
|
20 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=99 Participants
|
26 participants
n=107 Participants
|
53 participants
n=206 Participants
|
|
Height
|
131.62 centimeters
STANDARD_DEVIATION 15.244 • n=99 Participants
|
130.42 centimeters
STANDARD_DEVIATION 15.377 • n=107 Participants
|
131.03 centimeters
STANDARD_DEVIATION 15.174 • n=206 Participants
|
|
Weight
|
31.57 kilograms
STANDARD_DEVIATION 12.106 • n=99 Participants
|
32.68 kilograms
STANDARD_DEVIATION 12.802 • n=107 Participants
|
32.12 kilograms
STANDARD_DEVIATION 12.345 • n=206 Participants
|
PRIMARY outcome
Timeframe: predose, various timeframes up to 5 hours post last dosePopulation: Intent to treat population
Heart rate measured at various timepoints: predose and timepoints after each of the three dosings. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).
Outcome measures
| Measure |
Levalbuterol 0.63 mg
n=51 Participants
Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
|
Arformoterol 7.5 Mcg
n=52 Participants
Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
|
Arformoterol 15 Mcg
n=40 Participants
Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
|
|---|---|---|---|
|
Mean Heart Rate
Predose (n=51,52,40)
|
87.6 beats per minute
Standard Deviation 12.56
|
84.7 beats per minute
Standard Deviation 14.11
|
87.0 beats per minute
Standard Deviation 17.47
|
|
Mean Heart Rate
15 min post dose 1 (n=51,52,40)
|
89.3 beats per minute
Standard Deviation 15.57
|
85.2 beats per minute
Standard Deviation 15.19
|
89.4 beats per minute
Standard Deviation 16.88
|
|
Mean Heart Rate
15 min post dose 2 (n=50,51,40)
|
95.4 beats per minute
Standard Deviation 12.94
|
87.5 beats per minute
Standard Deviation 14.88
|
92.5 beats per minute
Standard Deviation 18.60
|
|
Mean Heart Rate
30 min post dose 2 (n=47,50,40)
|
97.1 beats per minute
Standard Deviation 13.28
|
88.9 beats per minute
Standard Deviation 13.33
|
93.3 beats per minute
Standard Deviation 16.72
|
|
Mean Heart Rate
30 min post dose 1 (n=51,52,40)
|
90.9 beats per minute
Standard Deviation 14.47
|
86.6 beats per minute
Standard Deviation 14.63
|
89.5 beats per minute
Standard Deviation 15.59
|
|
Mean Heart Rate
60 min post dose 1 (n=51,51,40)
|
96.4 beats per minute
Standard Deviation 12.33
|
89.0 beats per minute
Standard Deviation 13.67
|
93.5 beats per minute
Standard Deviation 16.41
|
|
Mean Heart Rate
60 min post dose 2 (n=46,50,37)
|
100.4 beats per minute
Standard Deviation 16.60
|
89.3 beats per minute
Standard Deviation 13.97
|
96.1 beats per minute
Standard Deviation 12.80
|
|
Mean Heart Rate
30 min post last dose (n=49,52,40)
|
99.2 beats per minute
Standard Deviation 17.38
|
90.3 beats per minute
Standard Deviation 14.24
|
96.1 beats per minute
Standard Deviation 13.92
|
|
Mean Heart Rate
60 min post last dose (n=49,52,40)
|
96.0 beats per minute
Standard Deviation 16.45
|
93.3 beats per minute
Standard Deviation 13.06
|
97.1 beats per minute
Standard Deviation 14.95
|
|
Mean Heart Rate
1.5 hours post last dose (n=48,52,40)
|
96.2 beats per minute
Standard Deviation 17.29
|
91.8 beats per minute
Standard Deviation 11.75
|
95.3 beats per minute
Standard Deviation 16.42
|
|
Mean Heart Rate
2 hours post last dose (n=50,52,40)
|
93.0 beats per minute
Standard Deviation 16.23
|
91.2 beats per minute
Standard Deviation 11.77
|
95.9 beats per minute
Standard Deviation 14.57
|
|
Mean Heart Rate
2.5 hours post last dose (n=49,52,40)
|
94.1 beats per minute
Standard Deviation 16.22
|
90.2 beats per minute
Standard Deviation 14.61
|
94.8 beats per minute
Standard Deviation 15.66
|
|
Mean Heart Rate
3 hours post last dose (n=50,52,40)
|
94.1 beats per minute
Standard Deviation 14.84
|
90.6 beats per minute
Standard Deviation 13.57
|
93.4 beats per minute
Standard Deviation 16.04
|
|
Mean Heart Rate
3.5 hours post last dose (n=50,52,40)
|
93.3 beats per minute
Standard Deviation 14.65
|
89.8 beats per minute
Standard Deviation 13.20
|
95.0 beats per minute
Standard Deviation 15.16
|
|
Mean Heart Rate
4 hours post last dose (n=50,52,40)
|
94.0 beats per minute
Standard Deviation 12.68
|
89.3 beats per minute
Standard Deviation 11.76
|
94.5 beats per minute
Standard Deviation 14.94
|
|
Mean Heart Rate
4.5 hours post last dose (n=50,52,40)
|
93.3 beats per minute
Standard Deviation 13.71
|
89.6 beats per minute
Standard Deviation 12.50
|
93.9 beats per minute
Standard Deviation 16.49
|
|
Mean Heart Rate
5 hours post last dose (n=50,51,40)
|
92.4 beats per minute
Standard Deviation 15.36
|
89.8 beats per minute
Standard Deviation 14.16
|
92.9 beats per minute
Standard Deviation 14.51
|
PRIMARY outcome
Timeframe: predose, various timeframes up to 5 hours post last dosePopulation: Intent to treat population
Heart rate measured at various timepoints minus the heart rate at predose.
Outcome measures
| Measure |
Levalbuterol 0.63 mg
n=51 Participants
Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
|
Arformoterol 7.5 Mcg
n=52 Participants
Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
|
Arformoterol 15 Mcg
n=40 Participants
Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
|
|---|---|---|---|
|
Change From Predose in Mean Heart Rate
15 min post dose 1 (n=51,52,40)
|
1.6 beats per minute
Standard Deviation 10.27
|
0.5 beats per minute
Standard Deviation 9.40
|
2.3 beats per minute
Standard Deviation 10.33
|
|
Change From Predose in Mean Heart Rate
30 min post dose 1 (n=51,52,40)
|
3.2 beats per minute
Standard Deviation 11.91
|
2.0 beats per minute
Standard Deviation 11.06
|
2.5 beats per minute
Standard Deviation 11.14
|
|
Change From Predose in Mean Heart Rate
60 min post dose 1 (n=51,51,40)
|
8.7 beats per minute
Standard Deviation 10.70
|
4.4 beats per minute
Standard Deviation 11.85
|
6.5 beats per minute
Standard Deviation 12.62
|
|
Change From Predose in Mean Heart Rate
15 min post dose 2 (n=50,51,40)
|
7.8 beats per minute
Standard Deviation 10.72
|
2.8 beats per minute
Standard Deviation 11.48
|
5.5 beats per minute
Standard Deviation 12.89
|
|
Change From Predose in Mean Heart Rate
2.5 hours post last dose (n=49,52,40)
|
6.8 beats per minute
Standard Deviation 11.20
|
5.5 beats per minute
Standard Deviation 14.33
|
7.8 beats per minute
Standard Deviation 13.36
|
|
Change From Predose in Mean Heart Rate
3 hours post last dose (n=50,52,40)
|
6.7 beats per minute
Standard Deviation 10.94
|
5.9 beats per minute
Standard Deviation 12.74
|
6.4 beats per minute
Standard Deviation 13.31
|
|
Change From Predose in Mean Heart Rate
30 min post dose 2 (n=47,50,40)
|
10.0 beats per minute
Standard Deviation 10.67
|
4.5 beats per minute
Standard Deviation 10.46
|
6.3 beats per minute
Standard Deviation 12.90
|
|
Change From Predose in Mean Heart Rate
60 min post dose 2 (n=46,50,37)
|
13.2 beats per minute
Standard Deviation 13.81
|
4.7 beats per minute
Standard Deviation 10.50
|
9.5 beats per minute
Standard Deviation 12.89
|
|
Change From Predose in Mean Heart Rate
30 min post last dose (n=49,52,40)
|
11.9 beats per minute
Standard Deviation 14.11
|
5.6 beats per minute
Standard Deviation 11.44
|
9.0 beats per minute
Standard Deviation 13.34
|
|
Change From Predose in Mean Heart Rate
60 min post last dose (n=49,52,40)
|
8.7 beats per minute
Standard Deviation 13.97
|
8.6 beats per minute
Standard Deviation 14.06
|
10.0 beats per minute
Standard Deviation 14.81
|
|
Change From Predose in Mean Heart Rate
1.5 hours post last dose (n=48,52,40)
|
8.9 beats per minute
Standard Deviation 11.73
|
7.1 beats per minute
Standard Deviation 12.65
|
8.3 beats per minute
Standard Deviation 15.95
|
|
Change From Predose in Mean Heart Rate
2 hours post last dose (n=50,52,40)
|
5.6 beats per minute
Standard Deviation 12.13
|
6.6 beats per minute
Standard Deviation 10.77
|
8.9 beats per minute
Standard Deviation 12.69
|
|
Change From Predose in Mean Heart Rate
3.5 hours post last dose (n=50,52,40)
|
5.9 beats per minute
Standard Deviation 11.89
|
5.1 beats per minute
Standard Deviation 11.63
|
7.9 beats per minute
Standard Deviation 12.11
|
|
Change From Predose in Mean Heart Rate
4 hours post last dose (n=50,52,40)
|
6.6 beats per minute
Standard Deviation 10.30
|
4.6 beats per minute
Standard Deviation 13.51
|
7.4 beats per minute
Standard Deviation 11.62
|
|
Change From Predose in Mean Heart Rate
4.5 hours post last dose (n=50,52,40)
|
5.9 beats per minute
Standard Deviation 10.86
|
4.9 beats per minute
Standard Deviation 12.00
|
6.9 beats per minute
Standard Deviation 12.70
|
|
Change From Predose in Mean Heart Rate
5 hours post last dose (n=50,51,40)
|
5.0 beats per minute
Standard Deviation 12.03
|
5.3 beats per minute
Standard Deviation 12.41
|
5.8 beats per minute
Standard Deviation 12.55
|
PRIMARY outcome
Timeframe: predose, various timeframes up to 5 hours post last dosePopulation: Intent to treat population
Systolic blood pressure measured at various timepoints: predose and timepoints after each of the three dosings. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).
Outcome measures
| Measure |
Levalbuterol 0.63 mg
n=51 Participants
Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
|
Arformoterol 7.5 Mcg
n=52 Participants
Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
|
Arformoterol 15 Mcg
n=40 Participants
Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
|
|---|---|---|---|
|
Mean Systolic Blood Pressure
30 min post dose 1 (n=51,52,40)
|
104.6 mmHg
Standard Deviation 12.08
|
102.5 mmHg
Standard Deviation 10.20
|
100.3 mmHg
Standard Deviation 9.78
|
|
Mean Systolic Blood Pressure
60 min post dose 1 (n=51,51,40)
|
105.8 mmHg
Standard Deviation 9.31
|
102.7 mmHg
Standard Deviation 9.82
|
103.2 mmHg
Standard Deviation 10.82
|
|
Mean Systolic Blood Pressure
60 min post last dose (n=49,52,40)
|
106.1 mmHg
Standard Deviation 10.32
|
103.0 mmHg
Standard Deviation 11.87
|
104.9 mmHg
Standard Deviation 11.03
|
|
Mean Systolic Blood Pressure
3.5 hours post last dose (n=50,52,40)
|
103.4 mmHg
Standard Deviation 10.00
|
103.2 mmHg
Standard Deviation 11.38
|
101.4 mmHg
Standard Deviation 9.41
|
|
Mean Systolic Blood Pressure
4 hours post last dose (n=50,52,40)
|
103.6 mmHg
Standard Deviation 11.26
|
102.1 mmHg
Standard Deviation 10.14
|
100.5 mmHg
Standard Deviation 10.48
|
|
Mean Systolic Blood Pressure
4.5 hours post last dose (n=50,52,40)
|
104.5 mmHg
Standard Deviation 10.50
|
103.2 mmHg
Standard Deviation 10.96
|
101.5 mmHg
Standard Deviation 9.25
|
|
Mean Systolic Blood Pressure
Predose (n=51,52,40)
|
102.1 mmHg
Standard Deviation 10.80
|
101.5 mmHg
Standard Deviation 9.86
|
100.6 mmHg
Standard Deviation 10.36
|
|
Mean Systolic Blood Pressure
15 min post dose 1 (n=51,52,40)
|
102.9 mmHg
Standard Deviation 10.90
|
101.2 mmHg
Standard Deviation 11.07
|
102.6 mmHg
Standard Deviation 11.42
|
|
Mean Systolic Blood Pressure
15 min post dose 2 (n=50,51,40)
|
105.0 mmHg
Standard Deviation 11.20
|
101.7 mmHg
Standard Deviation 9.42
|
102.1 mmHg
Standard Deviation 12.20
|
|
Mean Systolic Blood Pressure
30 min post dose 2 (n=47,50,40)
|
106.4 mmHg
Standard Deviation 10.32
|
102.8 mmHg
Standard Deviation 9.26
|
101.9 mmHg
Standard Deviation 9.81
|
|
Mean Systolic Blood Pressure
60 min post dose 2 (n=46,50,37)
|
107.2 mmHg
Standard Deviation 12.05
|
101.9 mmHg
Standard Deviation 11.18
|
102.9 mmHg
Standard Deviation 9.95
|
|
Mean Systolic Blood Pressure
30 min post last dose (n=49,52,40)
|
105.0 mmHg
Standard Deviation 12.22
|
101.2 mmHg
Standard Deviation 11.72
|
101.6 mmHg
Standard Deviation 12.60
|
|
Mean Systolic Blood Pressure
1.5 hours post last dose (n=48,52,40)
|
104.8 mmHg
Standard Deviation 11.43
|
101.9 mmHg
Standard Deviation 11.67
|
103.0 mmHg
Standard Deviation 10.35
|
|
Mean Systolic Blood Pressure
2 hours post last dose (n=50,52,40)
|
104.6 mmHg
Standard Deviation 11.40
|
103.4 mmHg
Standard Deviation 10.81
|
101.8 mmHg
Standard Deviation 10.87
|
|
Mean Systolic Blood Pressure
2.5 hours post last dose (n=49,52,40)
|
103.0 mmHg
Standard Deviation 12.41
|
101.5 mmHg
Standard Deviation 10.58
|
101.3 mmHg
Standard Deviation 10.10
|
|
Mean Systolic Blood Pressure
3 hours post last dose (n=50,52,40)
|
106.1 mmHg
Standard Deviation 12.28
|
102.1 mmHg
Standard Deviation 10.84
|
101.9 mmHg
Standard Deviation 11.57
|
|
Mean Systolic Blood Pressure
5 hours post last dose (n=50,52,40)
|
106.7 mmHg
Standard Deviation 9.94
|
104.1 mmHg
Standard Deviation 10.46
|
102.1 mmHg
Standard Deviation 9.49
|
PRIMARY outcome
Timeframe: predose, various timeframes up to 5 hours post last dosePopulation: Intent to treat population
Mean systolic blood pressure measured at various timepoints minus the mean systolic blood pressure at predose
Outcome measures
| Measure |
Levalbuterol 0.63 mg
n=51 Participants
Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
|
Arformoterol 7.5 Mcg
n=52 Participants
Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
|
Arformoterol 15 Mcg
n=40 Participants
Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
|
|---|---|---|---|
|
Change From Predose in Mean Systolic Blood Pressure
15 min post dose 1 (n=51,52,40)
|
0.8 mmHg
Standard Deviation 10.58
|
-0.4 mmHg
Standard Deviation 9.57
|
2.0 mmHg
Standard Deviation 8.06
|
|
Change From Predose in Mean Systolic Blood Pressure
30 min post dose 1 (n=51,52,40)
|
2.6 mmHg
Standard Deviation 10.14
|
0.9 mmHg
Standard Deviation 6.97
|
-0.3 mmHg
Standard Deviation 7.68
|
|
Change From Predose in Mean Systolic Blood Pressure
60 min post dose 1 (n=51,51,40)
|
3.7 mmHg
Standard Deviation 8.60
|
1.1 mmHg
Standard Deviation 9.54
|
2.6 mmHg
Standard Deviation 7.97
|
|
Change From Predose in Mean Systolic Blood Pressure
15 min post dose 2 (n=50,51,40)
|
2.6 mmHg
Standard Deviation 8.94
|
-0.3 mmHg
Standard Deviation 9.28
|
1.6 mmHg
Standard Deviation 9.07
|
|
Change From Predose in Mean Systolic Blood Pressure
30 min post dose 2 (n=47,50,40)
|
3.3 mmHg
Standard Deviation 8.59
|
0.8 mmHg
Standard Deviation 9.01
|
1.4 mmHg
Standard Deviation 7.19
|
|
Change From Predose in Mean Systolic Blood Pressure
60 min post dose 2 (n=46,50,37)
|
4.0 mmHg
Standard Deviation 7.89
|
-0.3 mmHg
Standard Deviation 8.98
|
1.8 mmHg
Standard Deviation 8.87
|
|
Change From Predose in Mean Systolic Blood Pressure
30 min post last dose (n=49,52,40)
|
2.4 mmHg
Standard Deviation 10.72
|
-0.4 mmHg
Standard Deviation 9.37
|
1.1 mmHg
Standard Deviation 11.25
|
|
Change From Predose in Mean Systolic Blood Pressure
60 min post last dose (n=49,52,40)
|
3.5 mmHg
Standard Deviation 10.92
|
1.5 mmHg
Standard Deviation 11.17
|
4.4 mmHg
Standard Deviation 8.43
|
|
Change From Predose in Mean Systolic Blood Pressure
1.5 hours post last dose (n=48,52,40)
|
1.8 mmHg
Standard Deviation 9.70
|
0.3 mmHg
Standard Deviation 10.22
|
2.4 mmHg
Standard Deviation 8.06
|
|
Change From Predose in Mean Systolic Blood Pressure
2 hours post last dose (n=50,52,40)
|
2.3 mmHg
Standard Deviation 10.31
|
1.8 mmHg
Standard Deviation 10.18
|
1.3 mmHg
Standard Deviation 9.44
|
|
Change From Predose in Mean Systolic Blood Pressure
2.5 hours post last dose (n=49,52,40)
|
0.4 mmHg
Standard Deviation 10.12
|
-0.0 mmHg
Standard Deviation 8.80
|
0.7 mmHg
Standard Deviation 7.77
|
|
Change From Predose in Mean Systolic Blood Pressure
3 hours post last dose (n=50,52,40)
|
3.9 mmHg
Standard Deviation 10.58
|
0.6 mmHg
Standard Deviation 8.83
|
1.3 mmHg
Standard Deviation 7.28
|
|
Change From Predose in Mean Systolic Blood Pressure
3.5 hours post last dose (n=50,52,40)
|
1.2 mmHg
Standard Deviation 8.87
|
1.7 mmHg
Standard Deviation 10.18
|
0.9 mmHg
Standard Deviation 7.06
|
|
Change From Predose in Mean Systolic Blood Pressure
4 hours post last dose (n=50,52,40)
|
1.3 mmHg
Standard Deviation 11.08
|
0.6 mmHg
Standard Deviation 10.17
|
-0.0 mmHg
Standard Deviation 8.36
|
|
Change From Predose in Mean Systolic Blood Pressure
4.5 hours post last dose (n=50,52,40)
|
2.2 mmHg
Standard Deviation 10.37
|
1.7 mmHg
Standard Deviation 9.61
|
0.9 mmHg
Standard Deviation 8.26
|
|
Change From Predose in Mean Systolic Blood Pressure
5 hours post last dose (n=50,52,40)
|
4.5 mmHg
Standard Deviation 10.79
|
2.5 mmHg
Standard Deviation 8.90
|
1.6 mmHg
Standard Deviation 9.62
|
PRIMARY outcome
Timeframe: predose, various timeframes up to 5 hours post last dosePopulation: Intent to treat population
Diastolic blood pressure measured at various timepoints: predose and timepoints after each of the three dosings. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).
Outcome measures
| Measure |
Levalbuterol 0.63 mg
n=51 Participants
Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
|
Arformoterol 7.5 Mcg
n=52 Participants
Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
|
Arformoterol 15 Mcg
n=40 Participants
Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
|
|---|---|---|---|
|
Mean Diastolic Blood Pressure
Predose (n=51,52,40)
|
62.5 mmHg
Standard Deviation 8.19
|
63.2 mmHg
Standard Deviation 6.82
|
63.6 mmHg
Standard Deviation 9.77
|
|
Mean Diastolic Blood Pressure
15 min post dose 1 (n=51,52,40)
|
61.4 mmHg
Standard Deviation 9.32
|
62.0 mmHg
Standard Deviation 7.29
|
62.5 mmHg
Standard Deviation 8.52
|
|
Mean Diastolic Blood Pressure
30 min post dose 1 (n=51,52,40)
|
60.8 mmHg
Standard Deviation 8.34
|
62.5 mmHg
Standard Deviation 7.61
|
61.6 mmHg
Standard Deviation 7.56
|
|
Mean Diastolic Blood Pressure
60 min post dose 1 (n=51,51,40)
|
63.4 mmHg
Standard Deviation 7.72
|
62.5 mmHg
Standard Deviation 7.47
|
62.3 mmHg
Standard Deviation 9.38
|
|
Mean Diastolic Blood Pressure
15 min post dose 2 (n=50,51,40)
|
61.7 mmHg
Standard Deviation 8.76
|
63.3 mmHg
Standard Deviation 6.75
|
60.8 mmHg
Standard Deviation 8.81
|
|
Mean Diastolic Blood Pressure
30 min post dose 2 (n=47,50,40)
|
63.1 mmHg
Standard Deviation 7.35
|
62.2 mmHg
Standard Deviation 7.61
|
61.7 mmHg
Standard Deviation 8.86
|
|
Mean Diastolic Blood Pressure
60 min post dose 2 (n=46,50,37)
|
62.8 mmHg
Standard Deviation 8.07
|
62.0 mmHg
Standard Deviation 8.15
|
62.3 mmHg
Standard Deviation 7.99
|
|
Mean Diastolic Blood Pressure
30 min post last dose (n=49,52,40)
|
63.4 mmHg
Standard Deviation 7.27
|
62.0 mmHg
Standard Deviation 8.83
|
61.6 mmHg
Standard Deviation 7.91
|
|
Mean Diastolic Blood Pressure
60 min post last dose (n=49,52,40)
|
63.5 mmHg
Standard Deviation 8.88
|
62.1 mmHg
Standard Deviation 8.60
|
62.5 mmHg
Standard Deviation 8.09
|
|
Mean Diastolic Blood Pressure
1.5 hours post last dose (n=48,52,40)
|
63.1 mmHg
Standard Deviation 9.09
|
62.3 mmHg
Standard Deviation 7.90
|
62.5 mmHg
Standard Deviation 9.03
|
|
Mean Diastolic Blood Pressure
2 hours post last dose (n=50,52,40)
|
63.8 mmHg
Standard Deviation 10.79
|
62.3 mmHg
Standard Deviation 6.87
|
62.1 mmHg
Standard Deviation 9.62
|
|
Mean Diastolic Blood Pressure
2.5 hours post last dose (n=49,52,40)
|
60.7 mmHg
Standard Deviation 10.41
|
59.7 mmHg
Standard Deviation 7.97
|
62.3 mmHg
Standard Deviation 8.71
|
|
Mean Diastolic Blood Pressure
3 hours post last dose (n=50,52,40)
|
63.2 mmHg
Standard Deviation 8.85
|
61.4 mmHg
Standard Deviation 7.51
|
62.5 mmHg
Standard Deviation 9.77
|
|
Mean Diastolic Blood Pressure
3.5 hours post last dose (n=50,52,40)
|
62.0 mmHg
Standard Deviation 9.80
|
60.5 mmHg
Standard Deviation 6.54
|
62.6 mmHg
Standard Deviation 7.59
|
|
Mean Diastolic Blood Pressure
4 hours post last dose (n=50,52,40)
|
62.9 mmHg
Standard Deviation 10.15
|
63.1 mmHg
Standard Deviation 7.32
|
59.9 mmHg
Standard Deviation 8.65
|
|
Mean Diastolic Blood Pressure
4.5 hours post last dose (n=50,52,40)
|
62.6 mmHg
Standard Deviation 9.12
|
62.2 mmHg
Standard Deviation 7.84
|
61.9 mmHg
Standard Deviation 8.38
|
|
Mean Diastolic Blood Pressure
5 hours post last dose (n=50,52,40)
|
62.3 mmHg
Standard Deviation 8.75
|
63.0 mmHg
Standard Deviation 7.40
|
60.0 mmHg
Standard Deviation 8.59
|
PRIMARY outcome
Timeframe: predose, various timeframes up to 5 hours post last dosePopulation: Intent to treat population
Mean diastolic blood pressure measured at various timepoints minus the predose diastolic blood pressure
Outcome measures
| Measure |
Levalbuterol 0.63 mg
n=51 Participants
Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
|
Arformoterol 7.5 Mcg
n=52 Participants
Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
|
Arformoterol 15 Mcg
n=40 Participants
Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
|
|---|---|---|---|
|
Change From Predose in Mean Diastolic Blood Pressure
15 min post dose 1 (n=51,52,40)
|
-1.1 mmHg
Standard Deviation 8.60
|
-1.1 mmHg
Standard Deviation 7.26
|
-1.0 mmHg
Standard Deviation 10.23
|
|
Change From Predose in Mean Diastolic Blood Pressure
30 min post dose 1 (n=51,52,40)
|
-1.7 mmHg
Standard Deviation 7.69
|
-0.6 mmHg
Standard Deviation 7.84
|
-1.9 mmHg
Standard Deviation 7.27
|
|
Change From Predose in Mean Diastolic Blood Pressure
60 min post dose 1 (n=51,51,40)
|
0.8 mmHg
Standard Deviation 7.89
|
-0.7 mmHg
Standard Deviation 7.71
|
-1.3 mmHg
Standard Deviation 9.43
|
|
Change From Predose in Mean Diastolic Blood Pressure
15 min post dose 2 (n=50,51,40)
|
-1.1 mmHg
Standard Deviation 8.10
|
0.1 mmHg
Standard Deviation 6.85
|
-2.8 mmHg
Standard Deviation 9.65
|
|
Change From Predose in Mean Diastolic Blood Pressure
30 min post dose 2 (n=47,50,40)
|
0.8 mmHg
Standard Deviation 7.82
|
-1.1 mmHg
Standard Deviation 7.59
|
-1.9 mmHg
Standard Deviation 9.59
|
|
Change From Predose in Mean Diastolic Blood Pressure
60 min post dose 2 (n=46,50,37)
|
0.0 mmHg
Standard Deviation 7.08
|
-1.3 mmHg
Standard Deviation 6.98
|
-1.8 mmHg
Standard Deviation 6.91
|
|
Change From Predose in Mean Diastolic Blood Pressure
30 min post last dose (n=49,52,40)
|
0.8 mmHg
Standard Deviation 7.12
|
-1.2 mmHg
Standard Deviation 7.34
|
-1.9 mmHg
Standard Deviation 9.35
|
|
Change From Predose in Mean Diastolic Blood Pressure
60 min post last dose (n=49,52,40)
|
0.8 mmHg
Standard Deviation 8.84
|
-1.1 mmHg
Standard Deviation 8.48
|
-1.1 mmHg
Standard Deviation 8.31
|
|
Change From Predose in Mean Diastolic Blood Pressure
1.5 hours post last dose (n=48,52,40)
|
0.1 mmHg
Standard Deviation 8.00
|
-0.9 mmHg
Standard Deviation 7.23
|
-1.1 mmHg
Standard Deviation 9.38
|
|
Change From Predose in Mean Diastolic Blood Pressure
2 hours post last dose (n=50,52,40)
|
1.4 mmHg
Standard Deviation 10.16
|
-0.9 mmHg
Standard Deviation 7.70
|
-1.5 mmHg
Standard Deviation 9.39
|
|
Change From Predose in Mean Diastolic Blood Pressure
2.5 hours post last dose (n=49,52,40)
|
-1.9 mmHg
Standard Deviation 8.66
|
-3.5 mmHg
Standard Deviation 7.36
|
-1.3 mmHg
Standard Deviation 9.56
|
|
Change From Predose in Mean Diastolic Blood Pressure
3 hours post last dose (n=50,52,40)
|
0.8 mmHg
Standard Deviation 8.45
|
-1.8 mmHg
Standard Deviation 8.31
|
-1.1 mmHg
Standard Deviation 10.49
|
|
Change From Predose in Mean Diastolic Blood Pressure
3.5 hours post last dose (n=50,52,40)
|
-0.4 mmHg
Standard Deviation 8.36
|
-2.6 mmHg
Standard Deviation 6.66
|
-1.0 mmHg
Standard Deviation 8.87
|
|
Change From Predose in Mean Diastolic Blood Pressure
4 hours post last dose (n=50,52,40)
|
0.5 mmHg
Standard Deviation 10.38
|
-0.0 mmHg
Standard Deviation 7.63
|
-3.7 mmHg
Standard Deviation 10.29
|
|
Change From Predose in Mean Diastolic Blood Pressure
4.5 hours post last dose (n=50,52,40)
|
0.2 mmHg
Standard Deviation 8.86
|
-1.0 mmHg
Standard Deviation 7.64
|
-1.7 mmHg
Standard Deviation 10.42
|
|
Change From Predose in Mean Diastolic Blood Pressure
5 hours post last dose (n=50,52,40)
|
-0.1 mmHg
Standard Deviation 8.84
|
-0.1 mmHg
Standard Deviation 8.06
|
-3.6 mmHg
Standard Deviation 10.25
|
PRIMARY outcome
Timeframe: Predose, 2 hours and 6 hours postdose 1Population: Intent to treat population
Outcome measures
| Measure |
Levalbuterol 0.63 mg
n=51 Participants
Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
|
Arformoterol 7.5 Mcg
n=52 Participants
Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
|
Arformoterol 15 Mcg
n=39 Participants
Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
|
|---|---|---|---|
|
Mean Serum Potassium Levels
Predose (n=51,52,39)
|
4.25 mEq/L
Standard Deviation 0.376
|
4.27 mEq/L
Standard Deviation 0.386
|
4.31 mEq/L
Standard Deviation 0.325
|
|
Mean Serum Potassium Levels
2 hours post dose 1 (n=48,47,38)
|
3.67 mEq/L
Standard Deviation 0.423
|
3.83 mEq/L
Standard Deviation 0.391
|
3.71 mEq/L
Standard Deviation 0.410
|
|
Mean Serum Potassium Levels
6 hours post dose 1 (n=48,49,38)
|
3.99 mEq/L
Standard Deviation 0.334
|
3.95 mEq/L
Standard Deviation 0.325
|
3.87 mEq/L
Standard Deviation 0.435
|
PRIMARY outcome
Timeframe: predose, 2 and 6 hours post dosePopulation: Intent to treat population
Change in mean serum potassium at the specified timepoint minus the predose value.
Outcome measures
| Measure |
Levalbuterol 0.63 mg
n=51 Participants
Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
|
Arformoterol 7.5 Mcg
n=52 Participants
Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
|
Arformoterol 15 Mcg
n=39 Participants
Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
|
|---|---|---|---|
|
Change From Predose in Mean Serum Potassium
2 hours post dose 1 (n=48,47,38)
|
-0.58 mEq/L
Standard Deviation 0.457
|
-0.42 mEq/L
Standard Deviation 0.407
|
-0.62 mEq/L
Standard Deviation 0.401
|
|
Change From Predose in Mean Serum Potassium
6 hours post dose 1 (n=48,49,38)
|
-0.23 mEq/L
Standard Deviation 0.307
|
-0.31 mEq/L
Standard Deviation 0.450
|
-0.39 mEq/L
Standard Deviation 0.424
|
PRIMARY outcome
Timeframe: Predose, 2 and 6 hours post dose 1Population: Intent to treat population
Outcome measures
| Measure |
Levalbuterol 0.63 mg
n=51 Participants
Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
|
Arformoterol 7.5 Mcg
n=52 Participants
Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
|
Arformoterol 15 Mcg
n=40 Participants
Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
|
|---|---|---|---|
|
Mean Serum Glucose Values
Predose (n=51,52,40)
|
86.4 mg/dl
Standard Deviation 15.59
|
87.5 mg/dl
Standard Deviation 15.43
|
87.6 mg/dl
Standard Deviation 17.41
|
|
Mean Serum Glucose Values
2 hours post dose 1 (n=48,47,39)
|
114.5 mg/dl
Standard Deviation 30.42
|
108.6 mg/dl
Standard Deviation 27.51
|
120.6 mg/dl
Standard Deviation 32.52
|
|
Mean Serum Glucose Values
6 hours post dose 1 (n=49,48,38)
|
107.6 mg/dl
Standard Deviation 18.43
|
99.0 mg/dl
Standard Deviation 15.78
|
106.3 mg/dl
Standard Deviation 15.64
|
PRIMARY outcome
Timeframe: predose, 2 and 6 hours post dosePopulation: Intent to treat population
Change in mean serum glucose at the specified timepoint minus the predose value.
Outcome measures
| Measure |
Levalbuterol 0.63 mg
n=51 Participants
Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
|
Arformoterol 7.5 Mcg
n=52 Participants
Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
|
Arformoterol 15 Mcg
n=40 Participants
Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
|
|---|---|---|---|
|
Change From Predose in Mean Serum Glucose
2 hours post dose 1 (n=48,47,39)
|
27.1 mg/dl
Standard Deviation 34.74
|
22.4 mg/dl
Standard Deviation 32.66
|
32.9 mg/dl
Standard Deviation 35.21
|
|
Change From Predose in Mean Serum Glucose
6 hours post dose 1 (n=49,48,38)
|
20.3 mg/dl
Standard Deviation 22.49
|
12.1 mg/dl
Standard Deviation 20.59
|
18.6 mg/dl
Standard Deviation 23.11
|
SECONDARY outcome
Timeframe: predose, various postdose timesPopulation: Intent to treat population. Pulmonary function testing was only performed on subjects six years of age or older; there were no subjects five or younger who performed spirometry. Subject data for those who were misdosed with ARF 7.5mcg rather than ARF 15mcg in the open-label portion were excluded from these analyses.
Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer.
Outcome measures
| Measure |
Levalbuterol 0.63 mg
n=37 Participants
Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
|
Arformoterol 7.5 Mcg
n=38 Participants
Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
|
Arformoterol 15 Mcg
n=27 Participants
Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
|
|---|---|---|---|
|
Mean Forced Expiratory Volume in One Second(FEV1)
predose (n=37,38,27)
|
1.554 liters
Standard Deviation 0.374
|
1.552 liters
Standard Deviation 0.377
|
1.486 liters
Standard Deviation 0.294
|
|
Mean Forced Expiratory Volume in One Second(FEV1)
10 minutes post dose 1 (n=37,38,27)
|
1.714 liters
Standard Deviation 0.411
|
1.668 liters
Standard Deviation 0.403
|
1.620 liters
Standard Deviation 0.315
|
|
Mean Forced Expiratory Volume in One Second(FEV1)
25 minutes post dose 1 (n=37,37,27)
|
1.712 liters
Standard Deviation 0.425
|
1.695 liters
Standard Deviation 0.409
|
1.644 liters
Standard Deviation 0.334
|
|
Mean Forced Expiratory Volume in One Second(FEV1)
10 minutes post dose 2 (n=36,38,27)
|
1.741 liters
Standard Deviation 0.430
|
1.721 liters
Standard Deviation 0.420
|
1.661 liters
Standard Deviation 0.332
|
|
Mean Forced Expiratory Volume in One Second(FEV1)
25 minutes post dose 2 (n=36,38,27)
|
1.735 liters
Standard Deviation 0.438
|
1.714 liters
Standard Deviation 0.423
|
1.669 liters
Standard Deviation 0.331
|
|
Mean Forced Expiratory Volume in One Second(FEV1)
4 hours post dose 1 (n=36,38,27)
|
1.732 liters
Standard Deviation 0.401
|
1.722 liters
Standard Deviation 0.423
|
1.684 liters
Standard Deviation 0.344
|
|
Mean Forced Expiratory Volume in One Second(FEV1)
6 hours post dose 1 (n=36,38,27)
|
1.667 liters
Standard Deviation 0.400
|
1.725 liters
Standard Deviation 0.426
|
1.660 liters
Standard Deviation 0.356
|
|
Mean Forced Expiratory Volume in One Second(FEV1)
10 minutes post dose 3 (n=34,38,27)
|
1.775 liters
Standard Deviation 0.402
|
1.731 liters
Standard Deviation 0.419
|
1.689 liters
Standard Deviation 0.340
|
|
Mean Forced Expiratory Volume in One Second(FEV1)
25 minutes post dose 3 (n=35,38,26)
|
1.782 liters
Standard Deviation 0.415
|
1.740 liters
Standard Deviation 0.419
|
1.700 liters
Standard Deviation 0.345
|
|
Mean Forced Expiratory Volume in One Second(FEV1)
2 hours post dose 1 (n=36,37,27)
|
1.784 liters
Standard Deviation 0.397
|
1.754 liters
Standard Deviation 0.408
|
1.704 liters
Standard Deviation 0.337
|
SECONDARY outcome
Timeframe: predose, various postdose timepointsPopulation: Intent to treat population. Pulmonary function testing was only performed on subjects six years of age or older; there were no subjects five or younger who performed spirometry. Subject data for those who were misdosed with ARF 7.5mcg rather than ARF 15mcg in the open-label portion were excluded from these analyses
Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. Change in FEV1 was calculated as postdose value minus the predose value at each visit.
Outcome measures
| Measure |
Levalbuterol 0.63 mg
n=37 Participants
Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
|
Arformoterol 7.5 Mcg
n=38 Participants
Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
|
Arformoterol 15 Mcg
n=27 Participants
Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
|
|---|---|---|---|
|
Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1)
10 minutes post dose 1 (n=37,38,27)
|
0.160 liters
Standard Deviation 0.102
|
0.117 liters
Standard Deviation 0.112
|
0.133 liters
Standard Deviation 0.105
|
|
Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1)
25 minutes post dose 1 (n=37,37,27)
|
0.159 liters
Standard Deviation 0.139
|
0.142 liters
Standard Deviation 0.151
|
0.158 liters
Standard Deviation 0.125
|
|
Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1)
10 minutes post dose 2 (n=36,38,27)
|
0.199 liters
Standard Deviation 0.130
|
0.169 liters
Standard Deviation 0.154
|
0.175 liters
Standard Deviation 0.106
|
|
Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1)
25 minutes post dose 2 (n=36,38,27)
|
0.194 liters
Standard Deviation 0.153
|
0.162 liters
Standard Deviation 0.166
|
0.183 liters
Standard Deviation 0.137
|
|
Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1)
10 minutes post dose 3 (n=34,38,27)
|
0.226 liters
Standard Deviation 0.144
|
0.179 liters
Standard Deviation 0.160
|
0.203 liters
Standard Deviation 0.148
|
|
Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1)
25 minutes post dose 3 (n=35,38,26)
|
0.226 liters
Standard Deviation 0.154
|
0.188 liters
Standard Deviation 0.150
|
0.205 liters
Standard Deviation 0.152
|
|
Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1)
2 hours post dose 1 (n=36,37,27)
|
0.216 liters
Standard Deviation 0.139
|
0.194 liters
Standard Deviation 0.146
|
0.218 liters
Standard Deviation 0.149
|
|
Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1)
4 hours post dose 1 (n=36,38,27)
|
0.163 liters
Standard Deviation 0.150
|
0.170 liters
Standard Deviation 0.175
|
0.198 liters
Standard Deviation 0.150
|
|
Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1)
6 hours post dose 1 (n=36,38,27)
|
0.098 liters
Standard Deviation 0.128
|
0.173 liters
Standard Deviation 0.165
|
0.174 liters
Standard Deviation 0.166
|
SECONDARY outcome
Timeframe: predose, various postdose timesPopulation: Intent to treat population. Pulmonary function testing was only performed on subjects six years of age or older; there were no subjects five or younger who performed spirometry. Subject data for those who were misdosed with ARF 7.5mcg rather than ARF 15mcg in the open-label portion were excluded from these analyses.
PEFR is the fastest rate at which air can move through the airways during a forced expiration starting with fully inflated lungs as measured by peak flow meters.
Outcome measures
| Measure |
Levalbuterol 0.63 mg
n=37 Participants
Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
|
Arformoterol 7.5 Mcg
n=38 Participants
Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
|
Arformoterol 15 Mcg
n=27 Participants
Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
|
|---|---|---|---|
|
Mean Peak Expiratory Flow Rate (PEFR)
predose (n=37,38,27)
|
3.604 liters/second
Standard Deviation 0.949
|
3.546 liters/second
Standard Deviation 0.928
|
3.565 liters/second
Standard Deviation 0.675
|
|
Mean Peak Expiratory Flow Rate (PEFR)
10 minutes post dose 1 (n=37,38,27)
|
3.926 liters/second
Standard Deviation 0.900
|
3.788 liters/second
Standard Deviation 0.950
|
3.824 liters/second
Standard Deviation 0.613
|
|
Mean Peak Expiratory Flow Rate (PEFR)
25 minutes post dose 1 (n=37,37,27)
|
4.003 liters/second
Standard Deviation 0.893
|
3.877 liters/second
Standard Deviation 0.950
|
3.844 liters/second
Standard Deviation 0.698
|
|
Mean Peak Expiratory Flow Rate (PEFR)
10 minutes post dose 2 (n=36,38,27)
|
4.053 liters/second
Standard Deviation 1.007
|
3.890 liters/second
Standard Deviation 0.998
|
3.925 liters/second
Standard Deviation 0.679
|
|
Mean Peak Expiratory Flow Rate (PEFR)
25 minutes post dose 2 (n=36,38,27)
|
4.047 liters/second
Standard Deviation 0.982
|
3.964 liters/second
Standard Deviation 0.912
|
3.989 liters/second
Standard Deviation 0.652
|
|
Mean Peak Expiratory Flow Rate (PEFR)
10 minutes post dose 3 (n=34,38,27)
|
4.156 liters/second
Standard Deviation 0.960
|
4.003 liters/second
Standard Deviation 0.993
|
4.077 liters/second
Standard Deviation 0.711
|
|
Mean Peak Expiratory Flow Rate (PEFR)
25 minutes post dose 3 (n=35,38,26)
|
4.176 liters/second
Standard Deviation 0.966
|
4.007 liters/second
Standard Deviation 0.899
|
4.017 liters/second
Standard Deviation 0.693
|
|
Mean Peak Expiratory Flow Rate (PEFR)
2 hours post dose 1 (n=36,37,27)
|
4.221 liters/second
Standard Deviation 0.961
|
4.178 liters/second
Standard Deviation 1.013
|
4.066 liters/second
Standard Deviation 0.668
|
|
Mean Peak Expiratory Flow Rate (PEFR)
4 hours post dose 1 (n=36,38,27)
|
4.155 liters/second
Standard Deviation 0.984
|
4.029 liters/second
Standard Deviation 1.061
|
4.039 liters/second
Standard Deviation 0.663
|
|
Mean Peak Expiratory Flow Rate (PEFR)
6 hours post dose 1 (n=36,38,27)
|
3.970 liters/second
Standard Deviation 0.938
|
4.058 liters/second
Standard Deviation 1.075
|
4.016 liters/second
Standard Deviation 0.628
|
SECONDARY outcome
Timeframe: predose, various postdose timesPopulation: Intent to treat population. Pulmonary function testing was only performed on subjects six years of age or older; there were no subjects five or younger who performed spirometry. Subject data for those who were misdosed with ARF 7.5mcg rather than ARF 15mcg in the open-label portion were excluded from these analyses.
PEFR is the fastest rate at which air can move through the airways during a forced expiration starting with fully inflated lungs as measured by peak flow meters. Change in PEFR was calculated as postdose value minus the predose value at each visit.
Outcome measures
| Measure |
Levalbuterol 0.63 mg
n=37 Participants
Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
|
Arformoterol 7.5 Mcg
n=38 Participants
Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
|
Arformoterol 15 Mcg
n=27 Participants
Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
|
|---|---|---|---|
|
Change From Predose in Mean Peak Expiratory Flow Rate (PEFR)
10 minutes post dose 1 (n=37,38,27)
|
0.322 liters/second
Standard Deviation 0.305
|
0.242 liters/second
Standard Deviation 0.298
|
0.259 liters/second
Standard Deviation 0.396
|
|
Change From Predose in Mean Peak Expiratory Flow Rate (PEFR)
25 minutes post dose 1 (n=37,37,27)
|
0.399 liters/second
Standard Deviation 0.367
|
0.320 liters/second
Standard Deviation 0.392
|
0.279 liters/second
Standard Deviation 0.442
|
|
Change From Predose in Mean Peak Expiratory Flow Rate (PEFR)
10 minutes post dose 2 (n=36,38,27)
|
0.458 liters/second
Standard Deviation 0.363
|
0.344 liters/second
Standard Deviation 0.369
|
0.360 liters/second
Standard Deviation 0.406
|
|
Change From Predose in Mean Peak Expiratory Flow Rate (PEFR)
25 minutes post dose 2 (n=36,38,27)
|
0.452 liters/second
Standard Deviation 0.329
|
0.419 liters/second
Standard Deviation 0.363
|
0.424 liters/second
Standard Deviation 0.383
|
|
Change From Predose in Mean Peak Expiratory Flow Rate (PEFR)
10 minutes post dose 3 (n=34,38,27)
|
0.524 liters/second
Standard Deviation 0.343
|
0.457 liters/second
Standard Deviation 0.439
|
0.513 liters/second
Standard Deviation 0.466
|
|
Change From Predose in Mean Peak Expiratory Flow Rate (PEFR)
25 minutes post dose 3 (n=35,38,26)
|
0.539 liters/second
Standard Deviation 0.375
|
0.462 liters/second
Standard Deviation 0.429
|
0.449 liters/second
Standard Deviation 0.497
|
|
Change From Predose in Mean Peak Expiratory Flow Rate (PEFR)
2 hours post dose 1 (n=36,37,27)
|
0.575 liters/second
Standard Deviation 0.385
|
0.596 liters/second
Standard Deviation 0.596
|
0.501 liters/second
Standard Deviation 0.408
|
|
Change From Predose in Mean Peak Expiratory Flow Rate (PEFR)
4 hours post dose 1 (n=36,38,27)
|
0.509 liters/second
Standard Deviation 0.345
|
0.484 liters/second
Standard Deviation 0.440
|
0.474 liters/second
Standard Deviation 0.449
|
|
Change From Predose in Mean Peak Expiratory Flow Rate (PEFR)
6 hours post dose 1 (n=36,38,27)
|
0.324 liters/second
Standard Deviation 0.337
|
0.513 liters/second
Standard Deviation 0.720
|
0.451 liters/second
Standard Deviation 0.462
|
SECONDARY outcome
Timeframe: predose, various postdose timesPopulation: PK population consisted of subjects who were in the intent-to-treat population and had any plasma concentration data available.
If the mean plasma concentration was 'below the limit of quantification' (BLQ) which was set as \<=0.5 picograms/milliliter, the value is displayed as a zero.
Outcome measures
| Measure |
Levalbuterol 0.63 mg
n=51 Participants
Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
|
Arformoterol 7.5 Mcg
n=52 Participants
Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
|
Arformoterol 15 Mcg
n=39 Participants
Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
|
|---|---|---|---|
|
Plasma Concentration of (R,R) Formoterol
predose (n=51,52,39)
|
0.646 picogram/milliliter
Standard Deviation 3.4172
|
0 picogram/milliliter
Standard Deviation 0.5159
|
0.737 picogram/milliliter
Standard Deviation 2.7612
|
|
Plasma Concentration of (R,R) Formoterol
25 minutes post dose 1 (n=50,46,36)
|
2.402 picogram/milliliter
Standard Deviation 15.1253
|
2.236 picogram/milliliter
Standard Deviation 13.0128
|
1.659 picogram/milliliter
Standard Deviation 2.4584
|
|
Plasma Concentration of (R,R) Formoterol
25 minutes post dose 2 (n=48,47,36)
|
0 picogram/milliliter
Standard Deviation 0.8858
|
1.845 picogram/milliliter
Standard Deviation 2.8085
|
3.325 picogram/milliliter
Standard Deviation 2.3515
|
|
Plasma Concentration of (R,R) Formoterol
2 hours post dose 1 (n=50,51,38)
|
0 picogram/milliliter
Standard Deviation 0.0000
|
1.885 picogram/milliliter
Standard Deviation 1.7035
|
4.189 picogram/milliliter
Standard Deviation 2.8207
|
|
Plasma Concentration of (R,R) Formoterol
6 hours post dose 1 (n=50,50,37)
|
0 picogram/milliliter
Standard Deviation 0.8899
|
0.874 picogram/milliliter
Standard Deviation 1.1988
|
2.818 picogram/milliliter
Standard Deviation 1.7195
|
Adverse Events
Levalbuterol 0.63 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Arformoterol 7.5 Mcg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Arformoterol 15 Mcg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Levalbuterol 0.63 mg
n=51 participants at risk
The experience of participants when treated with levalbuterol during the cross-over portion of the study.
|
Arformoterol 7.5 Mcg
n=52 participants at risk
The experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study.
|
Arformoterol 15 Mcg
n=40 participants at risk
The experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/51
|
1.9%
1/52 • Number of events 1
|
2.5%
1/40 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
2.0%
1/51 • Number of events 1
|
0.00%
0/52
|
0.00%
0/40
|
|
Gastrointestinal disorders
Stomach Discomfort
|
2.0%
1/51 • Number of events 1
|
0.00%
0/52
|
0.00%
0/40
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/51
|
0.00%
0/52
|
2.5%
1/40 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/51 • Number of events 1
|
0.00%
0/52
|
0.00%
0/40
|
|
General disorders
Fatigue
|
2.0%
1/51 • Number of events 1
|
0.00%
0/52
|
0.00%
0/40
|
|
General disorders
Pyrexia
|
2.0%
1/51 • Number of events 1
|
1.9%
1/52 • Number of events 1
|
0.00%
0/40
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/51
|
1.9%
1/52 • Number of events 1
|
0.00%
0/40
|
|
Infections and infestations
Influenza
|
3.9%
2/51 • Number of events 2
|
0.00%
0/52
|
0.00%
0/40
|
|
Infections and infestations
Nasopharyngitis
|
3.9%
2/51 • Number of events 2
|
0.00%
0/52
|
0.00%
0/40
|
|
Infections and infestations
Otitis Media
|
0.00%
0/51
|
0.00%
0/52
|
2.5%
1/40 • Number of events 1
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/51
|
0.00%
0/52
|
5.0%
2/40 • Number of events 2
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
2.0%
1/51 • Number of events 1
|
0.00%
0/52
|
0.00%
0/40
|
|
Investigations
Blood Glucose Increased
|
2.0%
1/51 • Number of events 1
|
0.00%
0/52
|
0.00%
0/40
|
|
Investigations
Blood Potassium Decreased
|
0.00%
0/51
|
1.9%
1/52 • Number of events 1
|
0.00%
0/40
|
|
Investigations
Electrocardiogram QT Prolonged
|
2.0%
1/51 • Number of events 1
|
0.00%
0/52
|
0.00%
0/40
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/51
|
0.00%
0/52
|
2.5%
1/40 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/51
|
0.00%
0/52
|
2.5%
1/40 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
2.0%
1/51 • Number of events 1
|
0.00%
0/52
|
0.00%
0/40
|
|
Nervous system disorders
Headache
|
0.00%
0/51
|
0.00%
0/52
|
2.5%
1/40 • Number of events 1
|
|
Nervous system disorders
Tremor
|
2.0%
1/51 • Number of events 1
|
0.00%
0/52
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/51
|
1.9%
1/52 • Number of events 1
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/51
|
1.9%
1/52 • Number of events 1
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/51
|
1.9%
1/52 • Number of events 1
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/51
|
0.00%
0/52
|
2.5%
1/40 • Number of events 1
|
Additional Information
Respiratory Medical Director
Sepracor Inc
Phone: 866-503-6351
Results disclosure agreements
- Principal investigator is a sponsor employee In addition to the \<60-180 day restriction above, since this is a multicenter study, 1st publication of study results shall be made with other participating study sites as a multicenter publication; provided, if a multicenter publication is not forthcoming within 24 months following completion of study at all sites, the PI shall be free to publish.
- Publication restrictions are in place
Restriction type: OTHER