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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013127
Receipt No. R000015309
Scientific Title Relationship between airway inflammation, airway remodeling and periostin in asthma
Date of disclosure of the study information 2014/02/10
Last modified on 2016/08/13

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Basic information
Public title Relationship between airway inflammation, airway remodeling and periostin in asthma
Acronym Relationship between airway inflammation, airway remodeling and periostin in asthma
Scientific Title Relationship between airway inflammation, airway remodeling and periostin in asthma
Scientific Title:Acronym Relationship between airway inflammation, airway remodeling and periostin in asthma
Region
Japan

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

Objectives
Narrative objectives1 To investigate the association between airway inflammation, airway remodeling and periostin in asthma
Basic objectives2 Others
Basic objectives -Others Comparison of periostin levels between asthmatics and contol subjects
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Indices of chest CT and serum levels of periostin
Key secondary outcomes Cell counts of induced sputum
FeNO
Pulmonary function
QoL

Base
Study type

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Asthma patients
Interventions/Control_2 Control subjects
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients with asthma
2.Disease controls who underwent medical examination
Key exclusion criteria 1.Patients who have any coexisting pulmonary diseases other than asthma
2.Pregnancy or lactation
3.Patients judged to be unsuitable by the doctors
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Hoshino
Organization Atami Hospital International University of Health and Welfare
Division name Department of Respiratory Medicine
Zip code
Address 13-1 Higashikaigan-cho, Atami, Shizuoka
TEL 0557-81-9171
Email hoshino@iuhw.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Hoshino
Organization Atami Hospital International University of Health and Welfare
Division name Department of Respiratory Medicine
Zip code
Address 13-1 Higashikaigan-cho, Atami, Shizuoka
TEL 0557-81-9171
Homepage URL
Email hoshino@iuhw.ac.jp

Sponsor
Institute Atami Hospital International University of Health and Welfare
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor none
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 国際医療福祉大学熱海病院(静岡県)
Atami Hospital International University of Health and Welfare

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 10 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
2014 Year 02 Month 07 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 10 Day
Last follow-up date
2016 Year 02 Month 09 Day
Date of closure to data entry
2016 Year 02 Month 09 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 02 Month 10 Day
Last modified on
2016 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015309

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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