UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015642 |
|---|---|
| Receipt number | R000008613 |
| Scientific Title | Transdermal application of steroid to cervical trachea in patients with bronchial asthma and cough variant asthma |
| Date of disclosure of the study information | 2014/11/09 |
| Last modified on | 2014/11/09 14:48:44 |
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Basic information
Public title
Transdermal application of steroid to cervical trachea in patients with bronchial asthma and cough variant asthma
Acronym
Transdermal steroid treatment to tracheitis
Scientific Title
Transdermal application of steroid to cervical trachea in patients with bronchial asthma and cough variant asthma
Scientific Title:Acronym
Transdermal steroid treatment to tracheitis
Region
| Japan |
Condition
Condition
bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of trans-cutaneous application of steroid over the cervical trachea to asthmatic patients as another route of drug delivery other than conventional therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
response rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Trans-dermal application of steroid ointment.
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Bronchial asthma (BA), cough-variant asthma (CVA) or cough predominant asthma (CPA) patients whose symptoms was not adequately controlled by their current therapy including high-dose ICS, or by limited use of ICS due to oropharyngeal side effects such as hoarseness or stomatitis.
Key exclusion criteria
Those who have dermal disease on the site of application of the drug.
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Kamimura |
Organization
National Hospital Organization Disaster Medical Center
Division name
Pulmonology Department
Zip code
Address
Midorimachi 3256, Tachikawa, Tokyo
TEL
042-526-5511
tdmckamimura@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Kamimura |
Organization
National Hospital Organization Disaster Medical Center
Division name
Pulmonology Department
Zip code
Address
Midorimachi 3256, Tachikawa, Tokyo
TEL
042-526-5511
Homepage URL
tdmckamimura@yahoo.co.jp
Sponsor or person
Institute
National Hospital Organization Disaster Medical Center, Pulmonology Department
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
国立病院機構 災害医療センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 09 | 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
The existence of the responders to topical steroid ointment therapy to the cervical trachea strongly suggests that the trachea is also involved in airway inflammation site, and the therapy might be considered as a supplementary therapeutic method to the undercontrolled asthmatic cough.
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
| 2006 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 09 | Day |
Last modified on
| 2014 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008613
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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