UMIN-CTR Clinical Trial

Basic information
Public title	Relationship between airway wall thickness and carotoid intima-media thickness in asthma
Acronym	Relationship between airway wall thickness and carotoid intima-media thickness in asthma
Scientific Title	Relationship between airway wall thickness and carotoid intima-media thickness in asthma
Scientific Title:Acronym	Relationship between airway wall thickness and carotoid intima-media thickness in asthma
Region	Japan

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

Objectives
Narrative objectives1	To investigate the assocaition between airway remodeing and vascular remodeing in asthma
Basic objectives2	Others
Basic objectives -Others	To investigate the efficacy of inhaled corticosteroid on airway remodeing and vascular remodeing in asthma
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Indices of chest CT and carotoid ultrasonography
Key secondary outcomes	Pulmonary function FeNO Cell counts of induced sputum Metabolic variables and serum CRP Scores of QoL

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

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	3
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Asthma group
Interventions/Control_2	Control group
Interventions/Control_3	Steroid naive asthma patients treat with inhaled corticoteroid for 4 months
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Disease contorls who underwent medical examination 2. Asthma patients who have been not treated with oral corticosteroid
Key exclusion criteria	1. Patients who have any coexsisiting pulmonary diseases other than asthma 2. Pregnancy or lactation 3. Patients judged to be unsuitable by the doctors
Target sample size	150

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

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

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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	none
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	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	2012 Year 04 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	2011 Year 12 Month 27 Day
Date of IRB
Anticipated trial start date	2012 Year 04 Month 01 Day
Last follow-up date	2014 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 04 Month 30 Day
Last modified on	2014 Year 11 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009267

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