UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Crossover Study to Compare Lung Flute Method to Hypertonic Saline Inhalation Method in Induced Sputum in Healthy Japanese Adults Smorkers or Non Smorkers
Title of the study (Brief title)	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	Masako Aso
Organization	Kitasato University Hospital
Division name	Clinical trial Center
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	Rieko Tanaka
Organization	Kitasato University School of Medicine
Division name	Kitasato Clinical Research Center
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 06 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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