UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015642
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Last 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
Email tdmckamimura@yahoo.co.jp

Public contact
1st 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
Email tdmckamimura@yahoo.co.jp

Sponsor
Institute National Hospital Organization Disaster Medical Center, Pulmonology Department
Institute
Department

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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008613

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.