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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029900
Receipt No. 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

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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
Email 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
Email k-komatsuzaki.alle@yokohama.jrc.or.jp

Sponsor
Institute Yokohama city Minato red cross hospital
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034156

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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