Asthma
Conditions
Keywords
Asthma, Symbicort Turbuhaler
Brief summary
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.
Interventions
160/4.5μg for 3 days
0.4 mg for 3 days
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Provision of informed consent prior to any study specific procedures * A minimum of 6 months documented history of asthma according to the JGL2006/GINA2006 definition * FEV1\> 70% of predicted normal value pre-bronchodilator
Exclusion criteria
* Having a known or suspected allergy to study therapy (active drugs or additive) * Having a known clinical history of hypertension, relevant arrhythmias or other heart disease, eg, ischemic heart disease, cardiomyopathy, valvular heart disease, or heart failure * Having been treated with oral, parenteral or rectal glucocorticoids within 4 weeks, or with depot parenteral glucocorticoids within 3 months * Respiratory infection significantly affecting the asthma, as judged by the investigator within 4 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 3 days | Total number of adverse events |
| Serum Potassium - Average Concentration From Trapezoidal Area Under the Curve (AUC) | up to 740 min after start dosing for each treatment day | The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period. |
| Blood Glucose - Average Concentration From Trapezoidal Area Under the Curve (AUC) | up to 140 min after start dosing for each treatment day | The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period. |
| Electrocardiogram (ECG)- Average Trapezoidal Area Under the Curve (AUC) | up to 740 min after start dosing for each treatment day | 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. |
| Vital Sign (Blood Pressure)- Average Trapezoidal Area Under the Curve (AUC) | up to 740 min after start dosing for each treatment day | The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period. |
| Vital Sign (Pulse Rate)- Average Trapezoidal Area Under the Curve (AUC) | up to 740 min after start dosing for each treatment day | The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period. |
Countries
Japan
Participant flow
Recruitment details
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)
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Washout Period of 7 - 14 Days | Adverse Event | 2 | 0 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age Continuous | 44.3 years STANDARD_DEVIATION 14.8 |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 25 | 15 / 23 |
| serious Total, serious adverse events | 0 / 25 | 0 / 23 |
Outcome results
Primary
Adverse Events
Total number of adverse events
Time frame: 3 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Symbicort | Adverse Events | 14 adverse events |
| Terbutaline | Adverse Events | 24 adverse events |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | Blood Glucose - Average Concentration From Trapezoidal Area Under the Curve (AUC) | 121.1 mg/dLiters | Standard Deviation 20.3 |
| Terbutaline | Blood Glucose - Average Concentration From Trapezoidal Area Under the Curve (AUC) | 129.5 mg/dLiters | Standard Deviation 22 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | Electrocardiogram (ECG)- Average Trapezoidal Area Under the Curve (AUC) | 411.71 ms | Standard Deviation 15.07 |
| Terbutaline | Electrocardiogram (ECG)- Average Trapezoidal Area Under the Curve (AUC) | 414.33 ms | Standard Deviation 14.04 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | Serum Potassium - Average Concentration From Trapezoidal Area Under the Curve (AUC) | 4.01 mEq/L | Standard Deviation 0.25 |
| Terbutaline | Serum Potassium - Average Concentration From Trapezoidal Area Under the Curve (AUC) | 3.88 mEq/L | Standard Deviation 0.26 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | Vital Sign (Blood Pressure)- Average Trapezoidal Area Under the Curve (AUC) | 115.3 mmHg | Standard Deviation 6.3 |
| Terbutaline | Vital Sign (Blood Pressure)- Average Trapezoidal Area Under the Curve (AUC) | 114.9 mmHg | Standard Deviation 8 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | Vital Sign (Pulse Rate)- Average Trapezoidal Area Under the Curve (AUC) | 70.0 beats/min | Standard Deviation 6.6 |
| Terbutaline | Vital Sign (Pulse Rate)- Average Trapezoidal Area Under the Curve (AUC) | 74.1 beats/min | Standard Deviation 7.5 |