UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of non-invasive methods for diagnosis of asthma and chronic obstructive pulmonary disease (COPD) and for difference between asthma and COPD.
Title of the study (Brief title)	Development of non-invasive method for difference between asthma and COPD.
Region	Japan

Condition
Condition	Asthma and chronic obstructive pulmonary disease (COPD).
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose in this study is to develop non-invasive methods independent on effort for difference between asthma and COPD using new technology such as forced oscillation technique, metronome-paced hyperventilation technique for evaluation of dynamic hyperinflation, measurement of exhaled nitric oxide, analysis of exhaled breath condensate.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Decreases in respiratory impedance and dynamic hyperinflation and increases in exhaled nitric oxide 30 minute after the inhalation of a short-acting bronchodilator.
Key secondary outcomes	Analysis of proteins and peptides in exhaled breath condensate obtained before the inhalation of a short-acting bronchodilator.

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	Inhalation of procaterol hydrochloride 20 microgram.
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	15 years-old <
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	Healthy never-smokers without any presence and histories of chronic respiratory and allergic diseases, and patients with asthma and chronic obstructive pulmonary disease (COPD) recruited from out-patient clinic of Shinshu University Hospital.
Key exclusion criteria	Healthy subjects who have smoking history or have histories of asthma or chronic respiratory diseases are excluded. Asthyma patients who have smoking history or severe cardiovascular diseases are excluded. COPD patients complicated with asthma or who have histories of asthma or severe cardiovascular diseases are excluded.
Target sample size	90

Research contact person
Name of lead principal investigator	Keisaku Fujimoto
Organization	Shinshu University School of Medicine
Division name	Department of Biomedical Laboratory Sciences, Health Sciences.
Address	3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL	0263-37-2393
Email	keisaku@shinshu-u.ac.jp

Public contact
Name of contact person	Keisaku Fujimoto
Organization	Shinshu University School of Medicine
Division name	Department of Biomedical Laboratory Sciences, Health Sciences.
Address	3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL	0263-37-2393
Homepage URL
Email	keisaku@shinshu-u.ac.jp

Sponsor
Institute	Department of Biomedical Laboratory Sciences, Shinshu University School of Health Sciences.
Institute
Department

Funding Source
Organization	Hokuto Foundation for Bioscience
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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	信州大学医学部付属病院（長野県）

Other administrative information
Date of disclosure of the study information	2010 Year 03 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 10 Month 26 Day
Anticipated trial start date	2010 Year 03 Month 01 Day
Last follow-up date	2012 Year 10 Month 01 Day
Date of closure to data entry	2012 Year 12 Month 01 Day
Date trial data considered complete	2012 Year 12 Month 01 Day
Date analysis concluded	2012 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 02 Month 16 Day
Last modified on	2017 Year 08 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003856