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

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

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 Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Symbicort Turbuhaler; Drug: Terbutaline Turbuhaler

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Ibaragi, Japan
    • Research Site
  • Tokyo, Japan
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: First Symbicort, then Terbutaline; Symbicort Turbuhaler 160/4.5μg for 3 days First , then Terbutaline Turbuhaler 0.4 mg for 3 days	Drug: Symbicort Turbuhaler; 160/4.5μg for 3 days; Drug: Terbutaline Turbuhaler; 0.4 mg for 3 days
EXPERIMENTAL: First Turbuhaler, then Symbicort; Terbutaline Turbuhaler 0.4 mg for 3 days First, then Symbicort Turbuhaler 160/4.5μg for 3 days,	Drug: Symbicort Turbuhaler; 160/4.5μg for 3 days; Drug: Terbutaline Turbuhaler; 0.4 mg for 3 days

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

General Publications

• Saito T, Hasunuma T. Safety and tolerability of high-dose budesonide/formoterol via Turbuhaler(R) in Japanese patients with asthma: a randomized, double-blind, crossover, active comparator-controlled, phase III study. Clin Drug Investig. 2012 Jan 1;32(1):51-61. doi: 10.2165/11595440-000000000-00000.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (ACTUAL): July 1, 2009
• Study Completion (ACTUAL): July 1, 2009

Study Registration Dates

• First Submitted: February 5, 2009
• First Submitted That Met QC Criteria: February 5, 2009
• First Posted (ESTIMATE): February 6, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): August 29, 2012
• Last Update Submitted That Met QC Criteria: August 27, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Asthma; Symbicort Turbuhaler
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Sympathomimetics; Terbutaline; Budesonide, Formoterol Fumarate Drug Combination
• Other Study ID Numbers: D589LC00003