Study to Investigate the Safety and Efficacy of High Dose of Symbicort® SMART in Japanese Patients

Study Overview
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Brief Summary
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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.

Official Title
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A Comparison of Tolerability of 10 Inhalations of Symbicort® Turbuhaler® 160/4.5 μg and 10 Inhalations of Terbutaline Turbuhaler® 0.4 mg on Top of Symbicort® Turbuhaler® 160/4.5 μg 1 Inhalation Bid, Randomized, Double-blind, Cross Over, Phase III Study in Japanese Adults Asthma Patients

Conditions
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Asthma

Intervention / Treatment
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* Drug: Symbicort Turbuhaler
* Drug: Terbutaline Turbuhaler


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: First Symbicort, then Terbutaline<br>Symbicort Turbuhaler 160/4.5μg for 3 days First , then Terbutaline Turbuhaler 0.4 mg for 3 days | Drug: Symbicort Turbuhaler<br>* 160/4.5μg for 3 days<br>Drug: Terbutaline Turbuhaler<br>* 0.4 mg for 3 days<br>|
| Experimental: First Turbuhaler, then Symbicort<br>Terbutaline Turbuhaler 0.4 mg for 3 days First, then Symbicort Turbuhaler 160/4.5μg for 3 days, | Drug: Symbicort Turbuhaler<br>* 160/4.5μg for 3 days<br>Drug: Terbutaline Turbuhaler<br>* 0.4 mg for 3 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Total number of adverse events | 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. | 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. | 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. | 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. | 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. | up to 740 min after start dosing for each treatment day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Symbicort Turbuhaler