臨床研究等提出・公開システム

Date of registration	April. 13, 2009
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080220715

Scientific Title	A Comparison of Symbicort SMART (160/4.5mcg) and Symbicort Turbuhaler 160/4.5mcg, Plus Terbutaline Turbuhaler 0.4mg as Needed, for Treatment of Asthma - a 12-Month, Randomized, Double-Blind, Parallel Group, Active-Controlled, Multinational Phase 3 Study in Asthmatic Patients From 16 Years
Public Title	Symbicort SMART

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Contact for Scientific Queries	Name
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Contact for Public Queries	Name
	Contact Name for Public Queries	AstraZeneca KK
	Address	RD-clinical-information-Japan@astrazeneca.com
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	E-mail Address

Recruitment Status

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Study Type		Interventional
Study Design	Study Design	Double Blind, Efficacy Study, Parallel Assignment, Randomized, Treatment
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	- Diagnosis of asthma according to GINA 2007 with a documented history of at least 6 months duration - Turbuhaler-Prescribed use of inhaled GCS (any brand) for at least 12 weeksAges - Reversible airway obstruction, defined as an increase in 12% of FEV1 or more relative to baseline for all patients 15-30 minutes after inhalation of in total 2 x 0.4 mg terbutaline
	Exclusion Criteria	- Respiratory infection affecting the asthma, as judged by the investigator within 4 weeks - Intake of oral, rectal or parenteral GCS within 4 weeks and/or depot parenteral GCS within 12 weeks
	Minimum Age	16age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Asthma
Intervention(s)		investigational material(s) Generic name etc : ST INN of investigational material : Therapeutic category code : 229 Other agents affecting respiratory organs Dosage and Administration for Investigational material : Symbicort Turbuhaler 160/4.5 mcg, one inhalation bid plus as needed control material(s) Generic name etc : Terbutaline Turbuhaler INN of investigational material : Therapeutic category code : 225 Bronchodilators Dosage and Administration for Investigational material : Symbicort Turbuhaler 160/4.5 mcg, one inhalation bid plus terbutaline Turbuhaler 0.4 mcg as needed
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Primary Sponsor	AstraZeneca
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Secondary ID No.	JapicCTI-090742
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History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	Dec. 20, 2016	Detail	Changes
7	Dec. 20, 2016	Detail	Changes
6	June. 12, 2012	Detail	Changes
5	June. 12, 2012	Detail	Changes
4	Mar. 10, 2010	Detail	Changes
3	Mar. 10, 2010	Detail	Changes
2	April. 13, 2009	Detail	Changes
1	April. 13, 2009	Detail

List of change history