UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research for the treatment of inflammation of small airways in asthma
Title of the study (Brief title)	Research for the treatment of small airways in asthma
Region	Japan

Condition
Condition	asthma
Classification by specialty	Medicine in general Pneumology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To invesgtigate differences in the effects of particle sizes of inhaled medication on small airways in asthma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Effects on small airways inflammation of
Key secondary outcomes	Effects on various clinical indices including adherence

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Salmeterol/Fluticasone discus
Interventions/Control_2	Salmeterol/Fluticasone aerosol
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	adult asthma
Key exclusion criteria	tuberculosis, oneumonia, interstitial pneumonia, lung cancer
Target sample size	40

Research contact person
Name of lead principal investigator	Hisako Matsumoto
Organization	Graduate School on Medicine, Kyoto University
Division name	Respiratory Medicine
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL	+81-75-751-3830
Email	hmatsumo@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Tadao Nagasaki
Organization	Graduate School on Medicine, Kyoto University
Division name	Respiratory Medicine
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL	+81-75-751-3830
Homepage URL
Email	nagasaki@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Department of Respiratory Medicine, Graduate School on Medicine, Kyoto University
Institute
Department

Funding Source
Organization	selffunding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2013 Year 05 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 03 Month 20 Day
Anticipated trial start date	2013 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 03 Month 20 Day
Last modified on	2018 Year 08 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012042