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

This study has been completed.

First Received: February 5, 2009 Last Updated: September 9, 2009 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00837967

Purpose

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 bid in adult asthma patients.

Condition	Intervention	Phase
Asthma	Drug: Symbicort Turbuhaler Drug: Terbutaline Turbuhaler	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Pharmacodynamics Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Terbutaline Terbutaline sulfate Symbicort

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Adverse events, Clinical laboratory tests, ECG, Vital signs (blood pressure, pulse rate, body temperature) [ Time Frame: daily ] [ Designated as safety issue: No ]

Enrollment:	25
Study Start Date:	January 2009
Study Completion Date:	July 2009

Arms	Assigned Interventions
1: Experimental	Drug: Symbicort Turbuhaler 160/4.5μg for 3 days
2: Active Comparator	Drug: Terbutaline Turbuhaler 0.4 mg for 3 days

Eligibility

Ages Eligible for Study:	16 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00837967

Locations

Japan
Research Site
Tokyo, Japan
Research Site
Ibaragi, Japan

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Tomas Andersson, MD

AstraZeneca R&D Lund

More Information

No publications provided

Responsible Party:	AstraZeneca Pharmaceuticals ( Tomas Andersson, MD, Medical Science Director Symbicort )
Study ID Numbers:	D589LC00003
Study First Received:	February 5, 2009
Last Updated:	September 9, 2009
ClinicalTrials.gov Identifier:	NCT00837967 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by AstraZeneca:

Asthma
Symbicort Turbuhaler

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Symbicort
Bronchial Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Hormones
Adrenergic Agonists
Terbutaline
Hypersensitivity
Lung Diseases, Obstructive

Respiratory Tract Diseases
Tocolytic Agents
Therapeutic Uses
Immune System Diseases
Adrenergic beta-Agonists
Sympathomimetics
Budesonide
Asthma
Anti-Asthmatic Agents
Glucocorticoids
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010