Trial Outcomes & Findings for Study to Investigate the Safety and Efficacy of High Dose of Symbicort® SMART in Japanese Patients (NCT NCT00837967)
NCT ID: NCT00837967
Last Updated: 2012-08-29
Results Overview
Total number of adverse events
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
25 participants
Primary outcome timeframe
3 days
Results posted on
2012-08-29
Participant Flow
Patients recruited from 2 hospitals in Japan between January 2009 and July 2009. 28 patients enrolled; 25 patients randomized, 3 patients were not randomized (1 due to incorrect enrollment and 2 due to adverse event)
Participant milestones
| Measure |
Symbicort First, Then Terbutaline
Symbicort Turbuhaler 160/4.5μg for 3 days First , then Terbutaline Turbuhaler 0.4 mg for 3 days
|
Terbutaline First, Then Symbicort
Terbutaline Turbuhaler 0.4 mg for 3 days First, then Symbicort Turbuhaler 160/4.5μg for 3 days,
|
|---|---|---|
|
First Intervention
STARTED
|
13
|
12
|
|
First Intervention
COMPLETED
|
13
|
12
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout Period of 7 - 14 Days
STARTED
|
13
|
12
|
|
Washout Period of 7 - 14 Days
COMPLETED
|
11
|
12
|
|
Washout Period of 7 - 14 Days
NOT COMPLETED
|
2
|
0
|
|
Second Intervention
STARTED
|
11
|
12
|
|
Second Intervention
COMPLETED
|
11
|
12
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Symbicort First, Then Terbutaline
Symbicort Turbuhaler 160/4.5μg for 3 days First , then Terbutaline Turbuhaler 0.4 mg for 3 days
|
Terbutaline First, Then Symbicort
Terbutaline Turbuhaler 0.4 mg for 3 days First, then Symbicort Turbuhaler 160/4.5μg for 3 days,
|
|---|---|---|
|
Washout Period of 7 - 14 Days
Adverse Event
|
2
|
0
|
Baseline Characteristics
Study to Investigate the Safety and Efficacy of High Dose of Symbicort® SMART in Japanese Patients
Baseline characteristics by cohort
| Measure |
All Study Participants
n=25 Participants
|
|---|---|
|
Age Continuous
|
44.3 years
STANDARD_DEVIATION 14.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 daysTotal number of adverse events
Outcome measures
| Measure |
Symbicort
n=25 Participants
Symbicort Turbuhaler 160/4.5μg
|
Terbutaline
n=23 Participants
Terbutaline Turbuhaler 0.4 mg
|
|---|---|---|
|
Adverse Events
|
14 adverse events
|
24 adverse events
|
PRIMARY outcome
Timeframe: up to 740 min after start dosing for each treatment dayThe mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
Outcome measures
| Measure |
Symbicort
n=25 Participants
Symbicort Turbuhaler 160/4.5μg
|
Terbutaline
n=23 Participants
Terbutaline Turbuhaler 0.4 mg
|
|---|---|---|
|
Serum Potassium - Average Concentration From Trapezoidal Area Under the Curve (AUC)
|
4.01 mEq/L
Standard Deviation 0.25
|
3.88 mEq/L
Standard Deviation 0.26
|
PRIMARY outcome
Timeframe: up to 140 min after start dosing for each treatment dayThe mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
Outcome measures
| Measure |
Symbicort
n=25 Participants
Symbicort Turbuhaler 160/4.5μg
|
Terbutaline
n=23 Participants
Terbutaline Turbuhaler 0.4 mg
|
|---|---|---|
|
Blood Glucose - Average Concentration From Trapezoidal Area Under the Curve (AUC)
|
121.1 mg/dLiters
Standard Deviation 20.3
|
129.5 mg/dLiters
Standard Deviation 22.0
|
PRIMARY outcome
Timeframe: up to 740 min after start dosing for each treatment dayThe mean AUC of QTcF (ECG interval measured from the beginning of the Q wave to the end of the T wave, corrected for heart rate using Fridericia's formula)was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
Outcome measures
| Measure |
Symbicort
n=25 Participants
Symbicort Turbuhaler 160/4.5μg
|
Terbutaline
n=23 Participants
Terbutaline Turbuhaler 0.4 mg
|
|---|---|---|
|
Electrocardiogram (ECG)- Average Trapezoidal Area Under the Curve (AUC)
|
411.71 ms
Standard Deviation 15.07
|
414.33 ms
Standard Deviation 14.04
|
PRIMARY outcome
Timeframe: up to 740 min after start dosing for each treatment dayThe mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
Outcome measures
| Measure |
Symbicort
n=25 Participants
Symbicort Turbuhaler 160/4.5μg
|
Terbutaline
n=23 Participants
Terbutaline Turbuhaler 0.4 mg
|
|---|---|---|
|
Vital Sign (Blood Pressure)- Average Trapezoidal Area Under the Curve (AUC)
|
115.3 mmHg
Standard Deviation 6.3
|
114.9 mmHg
Standard Deviation 8.0
|
PRIMARY outcome
Timeframe: up to 740 min after start dosing for each treatment dayThe mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
Outcome measures
| Measure |
Symbicort
n=25 Participants
Symbicort Turbuhaler 160/4.5μg
|
Terbutaline
n=23 Participants
Terbutaline Turbuhaler 0.4 mg
|
|---|---|---|
|
Vital Sign (Pulse Rate)- Average Trapezoidal Area Under the Curve (AUC)
|
70.0 beats/min
Standard Deviation 6.6
|
74.1 beats/min
Standard Deviation 7.5
|
Adverse Events
Symbicort
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Terbutaline
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Symbicort
n=25 participants at risk
Symbicort Turbuhaler 160/4.5μg for 3 days
|
Terbutaline
n=23 participants at risk
Terbutaline Turbuhaler 0.4 mg for 3 days
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
8.0%
2/25
Of 25 patients in safety analysis set, 2 patients did not receive terbutaline due to adverse events lead to discontinuation. Therefore, data from 25 patients for Symbicort and 23 patients for terbutaline were used for the safety evaluation.
|
8.7%
2/23
Of 25 patients in safety analysis set, 2 patients did not receive terbutaline due to adverse events lead to discontinuation. Therefore, data from 25 patients for Symbicort and 23 patients for terbutaline were used for the safety evaluation.
|
|
Nervous system disorders
Tremor
|
12.0%
3/25
Of 25 patients in safety analysis set, 2 patients did not receive terbutaline due to adverse events lead to discontinuation. Therefore, data from 25 patients for Symbicort and 23 patients for terbutaline were used for the safety evaluation.
|
17.4%
4/23
Of 25 patients in safety analysis set, 2 patients did not receive terbutaline due to adverse events lead to discontinuation. Therefore, data from 25 patients for Symbicort and 23 patients for terbutaline were used for the safety evaluation.
|
|
Cardiac disorders
Palpitations
|
4.0%
1/25
Of 25 patients in safety analysis set, 2 patients did not receive terbutaline due to adverse events lead to discontinuation. Therefore, data from 25 patients for Symbicort and 23 patients for terbutaline were used for the safety evaluation.
|
13.0%
3/23
Of 25 patients in safety analysis set, 2 patients did not receive terbutaline due to adverse events lead to discontinuation. Therefore, data from 25 patients for Symbicort and 23 patients for terbutaline were used for the safety evaluation.
|
|
Cardiac disorders
Tachycardia
|
4.0%
1/25
Of 25 patients in safety analysis set, 2 patients did not receive terbutaline due to adverse events lead to discontinuation. Therefore, data from 25 patients for Symbicort and 23 patients for terbutaline were used for the safety evaluation.
|
13.0%
3/23
Of 25 patients in safety analysis set, 2 patients did not receive terbutaline due to adverse events lead to discontinuation. Therefore, data from 25 patients for Symbicort and 23 patients for terbutaline were used for the safety evaluation.
|
|
Investigations
Blood Pressure Decreased
|
8.0%
2/25
Of 25 patients in safety analysis set, 2 patients did not receive terbutaline due to adverse events lead to discontinuation. Therefore, data from 25 patients for Symbicort and 23 patients for terbutaline were used for the safety evaluation.
|
13.0%
3/23
Of 25 patients in safety analysis set, 2 patients did not receive terbutaline due to adverse events lead to discontinuation. Therefore, data from 25 patients for Symbicort and 23 patients for terbutaline were used for the safety evaluation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place