UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Continuous treatment or reliever use of inhaled corticosteroid in patients with cough variant asthma. Improvement effect of airway hyper-responsiveness.
Title of the study (Brief title)	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	Keiko Komatsuzaki
Organization	Yokohama city Minato red cross hospital
Division name	allergy center
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	Keiko Komatsuzaki
Organization	Yokohama city Minato red cross hospital
Division name	allergy center
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 11 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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