UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study to investigate the mechanism of steroid insensitivity in severe asthmatic patients
Title of the study (Brief title)	Study to investigate the steroid insensitivity in severe asthma
Region	Japan

Condition
Condition	Bronchial asthma
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To measure levels of biomarkers, which are related to steroid response, in induced sputum of asthmatic patients. To evaluate the relationships between their expression and clinical indices.
Basic objectives2	Others
Basic objectives -Others	Mechanisms which may affect drug responses
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Levels of biomarkers, which are related to steroid insensitiviry, in induced sputum
Key secondary outcomes	1)Expression of asthma related biomarkers in blood 2)Exhaled nitric oxide level 3)Indices of pulmonary function 4)Indices of airway responsiveness

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	1)Adult patients with bronchial asthma who receive outpatient treatment in our clinic 2)Patients who gave consult to the study 3)Healty subjects
Key exclusion criteria	1)Patients with pulmonary infectious diseases, or interstitial pneumonia, or Lung cancer 2)Patients who are considered inappropriate by physicians in charge
Target sample size	60

Research contact person
Name of lead principal investigator	Hisako Matsumoto
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Respiratory Medicine
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL	075-751-3830
Email	hmatsumo@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Tomoko Tajiri
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Respiratory Medicine
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL	075-751-3830
Homepage URL
Email	tomokot@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Kyoto University Graduate School of Medicine
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	京都大学医学部附属病院（京都府）

Other administrative information
Date of disclosure of the study information	2011 Year 03 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 12 Month 24 Day
Anticipated trial start date	2011 Year 03 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	Published
URL releasing results
Results
Other related information	1)Cross-sectional study in stable asthmatic patients on treatment 2)Longitudinal study in newly referred steroid-naive asthmatic patients

Management information
Registered date	2011 Year 02 Month 18 Day
Last modified on	2018 Year 03 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006069