UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023505 |
|---|---|
| Receipt number | R000027062 |
| Scientific Title | A Crossover Study to Compare Lung Flute Method to Hypertonic Saline Inhalation Method in Induced Sputum in Healthy Japanese Adults Smorkers or Non Smorkers |
| Date of disclosure of the study information | 2016/08/05 |
| Last modified on | 2016/12/15 15:48:43 |
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Basic information
Public title
A Crossover Study to Compare Lung Flute Method to Hypertonic Saline Inhalation Method in Induced Sputum in Healthy Japanese Adults Smorkers or Non Smorkers
Acronym
A Crossover Study of Method of extracting Induced Sputum in Healthy Adults
Scientific Title
A Crossover Study to Compare Lung Flute Method to Hypertonic Saline Inhalation Method in Induced Sputum in Healthy Japanese Adults Smorkers or Non Smorkers
Scientific Title:Acronym
A Crossover Study of Method of extracting Induced Sputum in Healthy Adults
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of the Induced Sputum rate between Lung Flute Method and Hypertonic Saline Inhalation Method
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Induced Sputum rate
Key secondary outcomes
Safety, Evaluation of Induced Sputum, Background
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Lung Flute Method (once a day)
Interventions/Control_2
Hypertonic Saline inhalation Method (once a day)
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
| 21 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All Subjects
1) Those who have ability to provide written consent to participate in the study.
2) It is a condition that grandparents are Japanese.
3) Healthy male subjects between the ages of 21 and 65 years at the time of obtaining informed consent.
3) Body mass index (BMI) between 18.5 and 25.0 kg/m2.
5) Judged to be healthy by the study physician based on medical examinations and clinical laboratory tests.
Smorkers
1) Smorkers eligible for inclusion in this study have to fulfill all of following criteria
(i) Those who continue to smoke over one year in the time of a screening.
(ii) Those who smoke average eleven cigarettes a day on a daily basis.
(iii) Those who tested positive for urinary cotinine during screening and date of survey.
Non Smorkers
1) Non Smorkers eligible for inclusion in this study have to fulfill all of following criteria
(i) Those who don't smoke cigarette on a daily basis or don't have experience smoking cigarettes continuation of over four weeks.
(ii) At least a period of one year before screening and during date of survey, those who don't use cigarette, roll-your-own cigarette, cigarillo, cigar, pipe, snuff, chewing tobacco or electronic cigarette (include non-nicotine type).
(iii) Those who tested negative for urinary cotinine during screening and date of survey.
Key exclusion criteria
1) Any subject with malignant neoplasm, of with a previous history of malignant neoplasm
2) Any subject being contracted by severe disease (circulatory disease, liver disease, kidney disease, blood disease, respiratory disease, chronic respiratory disease, asthma, bronchitis, endocrine metabolic disease or electrolyte imbalance) or having been contracted thereby in the past.
3) Any subject known to abuse drugs or who tests positive for a drug in urine screening tests.
4) Any subject with a positive serological response for syphilis, HIV antigen or antibody, HBs antigen, or HCV antibody.
5) Use of any medicine within 2 weeks before Screening day, need to use of any medicine during this study.
6) Those who used "stop smoking aid" within four weeks before screening or until end of second survey.
7) Participation in any other clinical trial within the past 16 weeks.
8) Persons who have donated more than 200 ml of blood in the past 4 weeks or more than 400 ml of blood in the past 12 weeks (more than 200 ml of blood in the past 4 weeks or more than 400 ml of blood in the past 16 weeks in female).
9) Women who are pregnant, maybe pregnant or lactation.
10) Women who can't use birth control during the period from screening to second survey.
11) Women who are lactation.
12) Any condition that, in the opinion of the investigator, would make the patient unsuitable for inclusion in the study.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masako Aso |
Organization
Kitasato University Hospital
Division name
Clinical trial Center
Zip code
Address
1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa, 252-0375 Japan
TEL
042-778-9965
masako.a@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rieko Tanaka |
Organization
Kitasato University School of Medicine
Division name
Kitasato Clinical Research Center
Zip code
Address
1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa, 252-0374 Japan
TEL
042-777-6308
Homepage URL
rieko_t@med.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University Hospital Clinical trial Center
Institute
Department
Personal name
Funding Source
Organization
Japan Tobacco Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
北里大学病院臨床試験センター（神奈川県）
Kitasato University Hospital Clinical trial Center (Kanagawa)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 27 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 04 | Day |
Date of closure to data entry
| 2016 | Year | 11 | Month | 21 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 05 | Day |
Last modified on
| 2016 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027062
