UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of the therapeutic effect with inhaled corticosteroid in clinical cough variant asthma;subtypes classified by impulse oscillometry system
Acronym	Comparison of the therapeutic effect with inhaled corticosteroid in clinical cough variant asthma subtypes classified by impulse oscillometry system
Scientific Title	Comparison of the therapeutic effect with inhaled corticosteroid in clinical cough variant asthma;subtypes classified by impulse oscillometry system
Scientific Title:Acronym	Comparison of the therapeutic effect with inhaled corticosteroid in clinical cough variant asthma subtypes classified by impulse oscillometry system
Region	Japan

Condition
Condition	cough variant asthma
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of inhaled corticosteroid in cough variant asthma subtypes
Basic objectives2	Others
Basic objectives -Others	usefulness of impulse oscillometry
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Leicester cough questionnaire score
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who were diagnosed with cough variant asthma
Key exclusion criteria	Patients who were not evaluated the therapeutic effect with LCQ score
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroyuki Sugawara
Organization	Sugawara internal medicine and respiratory clinic
Division name	respitatory medicine
Zip code
Address	Shirakabacho 1-18-9, Tomakomai, Hokkaido
TEL	0144-76-7011
Email	sugawara-clinic@cb3.so-net.ne.jp

Public contact
Name of contact person	1st name Middle name Last name Hiroyuki Sugawara
Organization	Sugawara internal medicine and respiratory clinic
Division name	respitatory medicine
Zip code
Address	Shirakabacho 1-18-9, Tomakomai, Hokkaido
TEL	0144-76-7011
Homepage URL
Email	sugawara-clinic@cb3.so-net.ne.jp

Sponsor
Institute	Sugawara internal medicine and respiratory clinic
Institute
Department

Funding Source
Organization	Sugawara internal medicine and respiratory clinic
Organization
Division
Category of Funding Organization	Self funding
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	2018 Year 08 Month 03 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	Completed
Date of protocol fixation	2018 Year 05 Month 10 Day
Date of IRB	2018 Year 06 Month 15 Day
Anticipated trial start date	2018 Year 08 Month 03 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry	2020 Year 12 Month 31 Day
Date trial data considered complete	2020 Year 12 Month 31 Day
Date analysis concluded	2020 Year 12 Month 31 Day

Other
Other related information	Retrospective observational study on evaluation of inhaled corticosteroid in patients with cough variant asthma

Management information
Registered date	2018 Year 08 Month 01 Day
Last modified on	2020 Year 09 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038294