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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023505
Receipt No. 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

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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
Email 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
Email rieko_t@med.kitasato-u.ac.jp

Sponsor
Institute Kitasato University Hospital Clinical trial Center
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027062

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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