UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to obtain an index which objectively evaluate decreased adherence to inhaled corticosteroid in asthma
Title of the study (Brief title)	an index for decreased adherence to inhaled corticosteroid
Region	Japan

Condition
Condition	Asthma
Classification by specialty	Pneumology Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The main objective of this study was to elucidate whether the rate of change of fractional expired nitric oxide concentration are biomarker for decreased adherence to inhaled corticosteroid in asthma.
Basic objectives2	Others
Basic objectives -Others	Biomarker Discovery
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Correlation of the rate of change of fractional expired nitric oxide concentration and inhaled corticosteroid use frequency
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	Subject is diagnosed with asthma according to the Japanese Asthma Prevention and Management Guidelines (JGL). Subject has signed the informed concent form.
Key exclusion criteria	Exclusion criteria included COPD, interstitial pneumonia, infectious disease, and active cancer.
Target sample size	1000

Research contact person
Name of lead principal investigator	Norihiro Harada
Organization	Juntendo University Faculty of Medicine and Graduate School of Medicine
Division name	Department of Respiratory Medicine
Address	3-1-3 Hongo, Bunkyo-ku,,Tokyo, Japan
TEL	03-5802-1063
Email	nor@juntendo.ac.jp

Public contact
Name of contact person	Norihiro Harada
Organization	Juntendo University Faculty of Medicine and Graduate School of Medicine
Division name	Department of Respiratory Medicine
Address	3-1-3 Hongo, Bunkyo-ku,,Tokyo, Japan
TEL	03-5802-1063
Homepage URL
Email	nor@juntendo.ac.jp

Sponsor
Institute	Department of Respiratory Medicine, Juntendo University Faculty of Medicine and Graduate School of Medicine
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
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	2016 Year 01 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 23 Day
Anticipated trial start date	2015 Year 04 Month 03 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	This study was to elucidate whether the rate of change of fractional expired nitric oxide concentration are biomarker for decreased adherence to inhaled corticosteroid in asthma.

Management information
Registered date	2016 Year 01 Month 25 Day
Last modified on	2019 Year 02 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019275