A Phase 3 interventional study of Symbicort Turbuhaler and Terbutaline Turbuhaler in Asthma, sponsored by AstraZeneca. Completed at 2 sites in Japan. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-08-29.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
The primary objective of the study is to compare the tolerability of Symbicort® Turbuhaler® 160/4.5 μg 10 inhalations with terbutaline Turbuhaler® 0.4 mg 10 inhalations for 3 days on top of Symbicort® Turbuhaler® 160/4.5 μg 1 inhalation twice a day (bid) in adult asthma patients.
3,920 studies on the registry are indexed under Asthma; 506 are open to participants now.
This study's enrollment of 25 is below the median of 83 across 2,751 interventional studies indexed under Asthma.
Browse Asthma studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Symbicort Turbuhaler 160/4.5μg for 3 days First , then Terbutaline Turbuhaler 0.4 mg for 3 days
Drug: Symbicort Turbuhaler · Drug: Terbutaline Turbuhaler
Terbutaline Turbuhaler 0.4 mg for 3 days First, then Symbicort Turbuhaler 160/4.5μg for 3 days,
Drug: Symbicort Turbuhaler · Drug: Terbutaline Turbuhaler
160/4.5μg for 3 days
0.4 mg for 3 days
Adverse Events
Total number of adverse events
Time frame: 3 days
Serum Potassium - Average Concentration From Trapezoidal Area Under the Curve (AUC)
The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
Time frame: up to 740 min after start dosing for each treatment day
Blood Glucose - Average Concentration From Trapezoidal Area Under the Curve (AUC)
The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
Time frame: up to 140 min after start dosing for each treatment day
Electrocardiogram (ECG)- Average Trapezoidal Area Under the Curve (AUC)
The 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.
Time frame: up to 740 min after start dosing for each treatment day
Vital Sign (Blood Pressure)- Average Trapezoidal Area Under the Curve (AUC)
The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
Time frame: up to 740 min after start dosing for each treatment day
Vital Sign (Pulse Rate)- Average Trapezoidal Area Under the Curve (AUC)
The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
Time frame: up to 740 min after start dosing for each treatment day
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)
| Milestone | Symbicort First, Then Terbutaline | Terbutaline First, Then Symbicort |
|---|---|---|
| Started | 13 | 12 |
| Completed | 13 | 12 |
| Not completed | 0 | 0 |
| Milestone | Symbicort First, Then Terbutaline | Terbutaline First, Then Symbicort |
|---|---|---|
| Started | 13 | 12 |
| Completed | 11 | 12 |
| Not completed | 2 | 0 |
| Withdrew: Adverse event | 2 | 0 |
| Milestone | Symbicort First, Then Terbutaline | Terbutaline First, Then Symbicort |
|---|---|---|
| Started | 11 | 12 |
| Completed | 11 | 12 |
| Not completed | 0 | 0 |
Total number of adverse events
| adverse events | Symbicort | Terbutaline |
|---|---|---|
| Adverse Events | 14 | 24 |
The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
| mEq/L | Symbicort | Terbutaline |
|---|---|---|
| Serum Potassium - Average Concentration From Trapezoidal Area Under the Curve (AUC) | 4.01 ± 0.25 | 3.88 ± 0.26 |
The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
| mg/dLiters | Symbicort | Terbutaline |
|---|---|---|
| Blood Glucose - Average Concentration From Trapezoidal Area Under the Curve (AUC) | 121.1 ± 20.3 | 129.5 ± 22.0 |
The 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.
| ms | Symbicort | Terbutaline |
|---|---|---|
| Electrocardiogram (ECG)- Average Trapezoidal Area Under the Curve (AUC) | 411.71 ± 15.07 | 414.33 ± 14.04 |
The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
| mmHg | Symbicort | Terbutaline |
|---|---|---|
| Vital Sign (Blood Pressure)- Average Trapezoidal Area Under the Curve (AUC) | 115.3 ± 6.3 | 114.9 ± 8.0 |
The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
| beats/min | Symbicort | Terbutaline |
|---|---|---|
| Vital Sign (Pulse Rate)- Average Trapezoidal Area Under the Curve (AUC) | 70.0 ± 6.6 | 74.1 ± 7.5 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Symbicort | — | 0/25 (0%) | 7/25 (28%) |
| Terbutaline | — | 0/23 (0%) | 15/23 (65.2%) |
| Event | Symbicort | Terbutaline |
|---|---|---|
| TremorNervous system disorders | 3/25 | 4/23 |
| PalpitationsCardiac disorders | 1/25 | 3/23 |
| TachycardiaCardiac disorders | 1/25 | 3/23 |
| Blood Pressure DecreasedInvestigations | 2/25 | 3/23 |
| NasopharyngitisInfections and infestations | 2/25 | 2/23 |
| Age Continuous(years) | All Study Participants |
|---|---|
| Mean | 44.3 ± 14.8 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 15 |
| Male | 10 |
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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