UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004275 |
|---|---|
| Receipt number | 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 11:58:56 |
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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
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
kawayama_tomotaka@med.kurume-u.ac.jp
Sponsor or person
Institute
Division of respirology, neurology, and rheumatology, Department of medicine, Kurume University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005127
