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

AstraZeneca25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Asthma

Interventions

Symbicort TurbuhalerDRUG

160/4.5μg for 3 days

Terbutaline TurbuhalerDRUG

0.4 mg for 3 days

Eligibility

Sex: ALLMin age: 16 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (2)

Research Site

Ibaraki, Japan

Research Site

Tokyo, Japan

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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