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UMIN-CTR Clinical Trial |
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Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000007865 |
Receipt No. | R000009267 |
Scientific Title | Relationship between airway wall thickness and carotoid intima-media thickness in asthma |
Date of disclosure of the study information | 2012/04/30 |
Last modified on | 2014/11/01 |
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 |
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Condition | ||
Condition | Bronchila asthma | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 150 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Atami Hospital
International University of Health and Welfare |
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Division name | Department of Respiratory Medicine | ||||||
Zip code | |||||||
Address | 13-1 Higashikaigan-cho, Atami, Shizuoka | ||||||
TEL | 0557-81-9171 | ||||||
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009267 |