Study to Investigate the Safety and Efficacy of High Dose of Symbicort SMART in Japanese Patients - Full Text View

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:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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
Experimental: 1	Drug: Symbicort Turbuhaler 160/4.5μg for 3 days
Active Comparator: 2	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
Ibaragi, Japan
Research Site
Tokyo, Japan

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Tomas Andersson, MD

AstraZeneca R&D Lund

More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Saito T, Hasunuma T. Safety and tolerability of high-dose budesonide/formoterol via Turbuhaler® 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.

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

Keywords provided by AstraZeneca:

Asthma
Symbicort Turbuhaler

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Terbutaline
Budesonide
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Sympathomimetics
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids

ClinicalTrials.gov processed this record on February 09, 2012