臨床研究等提出・公開システム

Date of registration	Dec. 10, 2015
Last modified on	Dec. 17, 2018
Trial ID	jRCT1080223039

Scientific Title	A non-interventional study to assess lung function in Japanese children and elderly
Public Title

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	DAIICHISANKYO Co.,Ltd.
	Address	http://www.daiichisankyo.co.jp/corporate/rd/measure/clinical/index.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		46
Study Type		Observational
Study Design	Study Design	Non-interventional, observational study
Study Design	Objective
Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	Persons aged either population below at informed consent 1. Between 1 and 12 years 2. Between 20 and 40 years 3. 75 years of age and older
	Exclusion Criteria	Persons who have participated in other clinical studies prior to informed consent Persons deemed unsuitable for study participation by the investigator
	Minimum Age	1age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		NA
Intervention(s)		investigational material(s) Generic name etc : NA INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : NA
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		VTI: Inhaled tidal volume (L) VTE: Exhaled tidal volume (L) tI: Inhaled time (sec) tE: Exhaled time (sec) f: frequency (bpm) Add other parameters as needed
Secondary Outcome

Primary Sponsor	DAIICHISANKYO Co.,Ltd.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name	refer to Japanese
Address
Phone Number
E-mail Address
Status of Review
Date of Approval

Secondary ID No.	JapicCTI-153093
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
5	Dec. 17, 2018	(this page)	Changes
4	April. 06, 2016	Detail	Changes
3	April. 06, 2016	Detail	Changes
2	Dec. 10, 2015	Detail	Changes
1	Dec. 10, 2015	Detail

List of change history