Second Hand Smoke Exposure Clinical Trial
Official title:
The Protective Role of the Nose During Acute Exposure to Passive Smoking.
Verified date | November 2013 |
Source | Hellenic Anticancer Society |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: Ministry of Health and Welfare |
Study type | Interventional |
The aim of this study was to compare the acute effects of second hand smoke exposure between nasal and oral breathing and to assess the potential protective role of the nose during acute exposure, in exposure conditions similar to those within a bar where smoking is permitted.
Status | Completed |
Enrollment | 21 |
Est. completion date | July 2013 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - healthy volunteer adults non-smokers Exclusion Criteria: - < 18 years old - Recent or chronic disease of the upper or lower respiratory system. - Current pregnancy - Breastfeeding women |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Greece | Hellenic Anticancer Society | Athens | Attiki |
Lead Sponsor | Collaborator |
---|---|
Hellenic Anticancer Society | National and Kapodistrian University of Athens |
Greece,
Vardavas CI, Anagnostopoulos N, Kougias M, Evangelopoulou V, Connolly GN, Behrakis PK. Acute pulmonary effects of sidestream secondhand smoke at simulated car concentrations. Xenobiotica. 2013 Jun;43(6):509-13. doi: 10.3109/00498254.2012.741272. Epub 2012 Dec 4. — View Citation
Vardavas CI, Anagnostopoulos N, Kougias M, Evangelopoulou V, Connolly GN, Behrakis PK. Short-term pulmonary effects of using an electronic cigarette: impact on respiratory flow resistance, impedance, and exhaled nitric oxide. Chest. 2012 Jun;141(6):1400-6. doi: 10.1378/chest.11-2443. Epub 2011 Dec 22. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | exhaled nitric oxide (FeNO) for the respiratory tract | To compare the changes between the two types of breathing | before exposure (Baseline) and after exposure with a 30 minutes interval | No |
Primary | plethysmography | plethysmography take place both at oral and nasal breathing twice before and after intervention. | before exposure (Baseline) and after exposure with a 30 minutes interval | No |
Secondary | Eye or nose irritation | During the exposure to second hand smoke that lasted 20 minutes the examinee had his /her mouth closed and filled in an evaluation Questionnaire about eye or nose irritation. | during the exposure to second hand smoke | No |