Healthy Adults
Conditions
Interventions
Lung Flute Method (once a day)
Hypertonic Saline inhalation Method (once a day)
Sponsors
Kitasato University Hospital Clinical trial Center
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Induced Sputum rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, Evaluation of Induced Sputum, Background | — |
Countries
Japan
Contacts
Public ContactRieko Tanaka
Kitasato University School of Medicine Kitasato Clinical Research Center
Outcome results
None listed