UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029900 |
|---|---|
| Receipt number | R000034156 |
| Scientific Title | Continuous treatment or reliever use of inhaled corticosteroid in patients with cough variant asthma. Improvement effect of airway hyper-responsiveness. |
| Date of disclosure of the study information | 2017/12/01 |
| Last modified on | 2017/11/09 16:29:45 |
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Basic information
Public title
Continuous treatment or reliever use of inhaled corticosteroid in patients with cough variant asthma. Improvement effect of airway hyper-responsiveness.
Acronym
Effect of inhaled corticosteroid in cough variant asthma.
Scientific Title
Continuous treatment or reliever use of inhaled corticosteroid in patients with cough variant asthma. Improvement effect of airway hyper-responsiveness.
Scientific Title:Acronym
Effect of inhaled corticosteroid in cough variant asthma.
Region
| Japan |
Condition
Condition
cough variant asthma
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparisons of regular use or reliever use of inhaled corticosteroid in patient with cough variant asthma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
airway hyperresponsiveness
Key secondary outcomes
questionnaire of cough
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Continuous treatment and releiver use of inhaled corticosteroid and long acting beta 2 agonists in a year.
Interventions/Control_2
only reliever use of inhaled corticosteroid and long acting beta 2 agonists.
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
| 15 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who diagnosed cough variant asthma at Yokohama city Minato red-cross hospital, and clinically have no symptoms in 3 months using ICS.
Key exclusion criteria
Patients with infectious disease of do not have effective antibiotics.
Patients who have hypersensitivity for using drugs.
Patients with Tuberculosis.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiko Komatsuzaki |
Organization
Yokohama city Minato red cross hospital
Division name
allergy center
Zip code
Address
3-12-21 Shinyamasita, Naka-ward, Yokohama, Kanagawa
TEL
045-628-6381
k-komatsuzaki.alle@yokohama.jrc.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiko Komatsuzaki |
Organization
Yokohama city Minato red cross hospital
Division name
allergy center
Zip code
Address
3-12-21 Shinyamashita, Naka-ward, Yokohama, Kanagawa
TEL
045-628-6381
Homepage URL
k-komatsuzaki.alle@yokohama.jrc.or.jp
Sponsor or person
Institute
Yokohama city Minato red cross hospital
Institute
Department
Personal name
Funding Source
Organization
Yokohama city Minato red cross hospital
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 09 | Day |
Last modified on
| 2017 | 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=R000034156
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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