UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Mechanisms of airway inflammation in severe/refractory asthma
Title of the study (Brief title)	Airway inflammation in severe asthma
Region	Japan

Condition
Condition	Bronchial asthma
Classification by specialty	Medicine in general Pneumology Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the mechanisms of airway inflammation in severe asthma
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Airway inflammation Lung function Asthma symptom Activity
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Anti-inflammatory drugs (e.g. Systemic corticosteroids)
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	severe asthma defined by the American Thoracic S0ciety Criteria
Key exclusion criteria	Respiratory failure Subjects at exacerbations of asthma
Target sample size	20

Research contact person
Name of lead principal investigator	Kazuto Matsunaga
Organization	Wakayama Medical University
Division name	Third Department of Internal Medicine
Address	811-1 Kimiidera, Wakayama
TEL
Email

Public contact
Name of contact person	Kazuto Matsunaga
Organization	Wakayama Medical University
Division name	Third Department of Internal Medicine
Address
TEL
Homepage URL
Email	kazmatsu@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University Third Department of Internal 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	2012 Year 07 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 04 Month 01 Day
Anticipated trial start date	2012 Year 07 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

Management information
Registered date	2012 Year 07 Month 11 Day
Last modified on	2016 Year 10 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009884