UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of smoking habit on lung function tests
Title of the study (Brief title)	Effect of smoking habit on lung function tests
Region	Japan

Condition
Condition	NA
Classification by specialty	Pneumology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigate the effect of smoking habit on lung function tests in healthy Japanese subjects.
Basic objectives2	Others
Basic objectives -Others	spirometry (FVC, FEV1.0. FEV1/FVC)
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Calculate basic statistics of smoker and non-smoker separately. Calculate basic statistics of lung function tests with/without bronchodilator (Beta 2 blocker) when the data is available. Conduct inter-group comparison of smoker / non-smoker or with / without bronchodilator. Compare acquired data with historical data.
Key secondary outcomes	Calculate basic statistics of sex, age, exhaled CO level, the number of cigarette smoke in smokers.

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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Male and Female Japanese subjects who participated clinical trial between December 2016 and May 2017, and who has following test data; - Demography: age, sex, height, weight and BMI. - General laboratory data and vital sign: BP (systolic and diastolic), pulse rate, laboratory data (WBC, Hb, Ht), Urine drug test. - Lung function tests: FVC, FEV1.0, FEV1/FVC - Other ( only for smoker): urine cotinine test (qualitative), exhaled Co and the number of cigarette smoked.
Key exclusion criteria	-
Target sample size	240

Research contact person
Name of lead principal investigator	Tatsuya Yoshihara
Organization	SOUSEIKAI Fukuoka Mirai Hospital Clinical Research Center
Division name	Clinical Pharmacology Department
Address	3-5-1 Kashiiteriha, Higashi-ku, Fukuoka
TEL	092-662-3608
Email	tatsuya-yoshihara@lta-med.com

Public contact
Name of contact person	Hiroko Kumashiro
Organization	SOUSEIKAI Hakata Clinic
Division name	Planning & Coordination Dept.
Address	Random Square (5th-7th floors) 6-18 Tenyamachi, Hakata-ku, Fukuoka, 812-0025
TEL	092-283-7701
Homepage URL
Email	hiroko-kumashiro@lta-med.com

Sponsor
Institute	SOUSEIKAI Fukuoka Mirai Hospital Clinical Research Center
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	医療法人相生会　福岡みらい病院　臨床研究センター（福岡県） 医療法人相生会　博多クリニック（福岡県）

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 26 Day
Anticipated trial start date	2017 Year 07 Month 05 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	Function of lung is evaluated by spirometry (FVC, FEV1.0. FEV1/FVC). These data of patients with respiratory illness is widely available, but data of healthy population is very limited. We have been accumulating spirometry data in both healthy smokers and non-smokers. We also acquired lung function test data with/without bronchodilator in healthy smokers to evaluate reversibility. In this study, we will investigate the effect of smoking habit on lung function by comparing data of healthy smokers and non- smokers.

Management information
Registered date	2017 Year 07 Month 13 Day
Last modified on	2017 Year 12 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032294