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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028213
Receipt No. R000032294
Scientific Title Effect of smoking habit on lung function tests
Date of disclosure of the study information 2017/07/13
Last modified on 2017/12/13

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Basic information
Public title Effect of smoking habit on lung function tests
Acronym Effect of smoking habit on lung function tests
Scientific Title Effect of smoking habit on lung function tests
Scientific Title:Acronym 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
1st name
Middle name
Last name Tatsuya Yoshihara
Organization SOUSEIKAI Fukuoka Mirai Hospital Clinical Research Center
Division name Clinical Pharmacology Department
Zip code
Address 3-5-1 Kashiiteriha, Higashi-ku, Fukuoka
TEL 092-662-3608
Email tatsuya-yoshihara@lta-med.com

Public contact
Name of contact person
1st name
Middle name
Last name Hiroko Kumashiro
Organization SOUSEIKAI Hakata Clinic
Division name Planning & Coordination Dept.
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 06 Month 26 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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