UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028213 |
|---|---|
| Receipt number | 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 15:11:07 |
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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
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
hiroko-kumashiro@lta-med.com
Sponsor or person
Institute
SOUSEIKAI Fukuoka Mirai Hospital Clinical Research Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032294
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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