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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004275
Receipt No. R000005127
Scientific Title Effects of budesonide and formoterol combination on airway regulatory T cells in mild asthmatics
Date of disclosure of the study information 2010/09/30
Last modified on 2018/01/10

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Basic information
Public title Effects of budesonide and formoterol combination on airway regulatory T cells in mild asthmatics
Acronym Effects of ICS+LABA on Tregs in asthma
Scientific Title Effects of budesonide and formoterol combination on airway regulatory T cells in mild asthmatics
Scientific Title:Acronym 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
1st name
Middle name
Last name Tomotaka Kawayama
Organization Kurume University School of Medicine
Division name Division of respirology, neurology, and rheumatology
Zip code
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
1st name
Middle name
Last name Tomotaka Kawayama
Organization Kurume University School of Medicine
Division name Division of respirology, neurology, and rheumatology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 07 Month 22 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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