臨床研究等提出・公開システム

Date of registration	Feb. 27, 2009
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080220680

Scientific Title	A Comparison of Tolerability of 10 Inhalations of Symbicort Turbuhaler 160/4.5 mcg and 10 Inhalations of Terbutaline Turbuhaler 0.4 mg on Top of Symbicort Turbuhaler 160/4.5 mcg 1 Inhalation Bid, Randomized, Double-Blind, Cross Over, Phase III Study in Japanese Adults Asthma Patients
Public Title	Symbicort SMART

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

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

Recruitment Status

Date of First Enrolment
Target Sample Size		24
Study Type		Interventional
Study Design	Study Design	Treatment, Randomized, Double Blind Crossover Assignment, Pharmacodynamics Study
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	-Provision of informed consent prior to any study specific procedure -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 with 3 months -Respiratory infection significantly affecting the asthma, as judged by the investigator within 4 weeks
	Minimum Age	16age old over
	Maximum Age	65age old under
	Gender	Both
Health Condition or Problem Studied		Asthma
Intervention(s)		investigational material(s) Generic name etc : Symbicort Turbuhaler INN of investigational material : Therapeutic category code : 229 Other agents affecting respiratory organs Dosage and Administration for Investigational material : Inhalation 160/4.5mcg for 3 days control material(s) Generic name etc : Terbutaline Turbuhaler INN of investigational material : Therapeutic category code : 225 Bronchodilators Dosage and Administration for Investigational material : Inhalation 0.4mg for 3 days
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Adverse events, Clinical laboratory tests, ECG, Vital signs(blood pressure, pulse rate, body temperature)
Secondary Outcome

Primary Sponsor	AstraZeneca
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-090705
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
7	Dec. 17, 2018	(this page)	Changes
6	Dec. 20, 2016	Detail	Changes
5	Dec. 20, 2016	Detail	Changes
4	June. 15, 2010	Detail	Changes
3	June. 15, 2010	Detail	Changes
2	Feb. 27, 2009	Detail	Changes
1	Feb. 27, 2009	Detail

List of change history