UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of budesonide and formoterol combination on airway regulatory T cells in mild asthmatics
Title of the study (Brief title)	Effects of ICS+LABA on Tregs in asthma
Region	Japan

Condition
Condition	mild asthma
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim is to investigate the effects of inhaled budesonide and formoterol combination on induced sputum regulatory T cells in asthmatics and compare with placebo and inhaled budesonide alone therapy.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement of induced sputum regulatory T cells
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	inhaled budesonide and formoterol combination
Interventions/Control_2	inhaled budesonide
Interventions/Control_3	placebo
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	1. mild asthmatics in according to GINA 2006 guideline 2. PC20 to methacholine < 16mg/mL 3. nonsmoker 4. stable within 4wks
Key exclusion criteria	1. user of inhaled, oral, or injective corticosteroids, leukotriene antagonists, long acting-beta2 agonists, DSCG, theophylline, immunosupressants, anti-allergic or anti-histamine agents within 4wks. 2. respiratory infections within 4wks. 3. histories of other severe organ diseases. 4. histories of psychological diseases. 5. pregnancy or nursing.
Target sample size	10

Research contact person
Name of lead principal investigator	Tomotaka Kawayama
Organization	Kurume University School of Medicine
Division name	Division of respirology, neurology, and rheumatology
Address	67 Asahi-machi, Kurume, Fukuoka, Japan
TEL	094-31-7560
Email	kawayama_tomotaka@med.kurume-u.ac.jp

Public contact
Name of contact person	Tomotaka Kawayama
Organization	Kurume University School of Medicine
Division name	Division of respirology, neurology, and rheumatology
Address	67 Asahimachi, Kurume
TEL	0942-31-7560
Homepage URL
Email	kawayama_tomotaka@med.kurume-u.ac.jp

Sponsor
Institute	Division of respirology, neurology, and rheumatology, Department of medicine, Kurume University School of Medicine
Institute
Department

Funding Source
Organization	Division of respirology, neurology, and rheumatology, Department of medicine, Kurume University School of Medicine
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	2010 Year 09 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 07 Month 22 Day
Anticipated trial start date	2010 Year 10 Month 01 Day
Last follow-up date	2014 Year 11 Month 01 Day
Date of closure to data entry	2014 Year 12 Month 30 Day
Date trial data considered complete	2014 Year 12 Month 30 Day
Date analysis concluded	2015 Year 03 Month 30 Day

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

Management information
Registered date	2010 Year 09 Month 28 Day
Last modified on	2018 Year 01 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005127