- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01988467
The Protective Role of the Nose During Acute Exposure to Passive Smoking.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Analysis of the laboratory testing:
The measurement of NO for the respiratory tract was performed with a Ecomedics CLD 88spNO analyzer as follows: the examinee performed tidal breathing with a closed nose, through a special mouthpiece and then took a deep breath and exhale steadily with a flow of 50ml/sec. After 3 attempts, during which we obtained an exhaled NO measurement each time, until we obtained a reliability index CV <10%.
For the oscillometry (IOS) of the respiratory tract the Master Screen IOS VIASYS was used, the examinee breathed quietly through the mouthpiece with his/her nose closed for a period of 1 minute. In this way we measured the impedance Z at 5 Hz, the resistance to 5,10,20 Hz respectively, the reactance in 5,10,20 Hz respectively, the central and peripheral airway resistance and resonant frequency.
Rhinomanometry was done by the Master Screen IOS VIASYS system, the examinee breathed calmly through the examined nostril, while the other was closed, 5 breaths per attempt were performed. After 3 attempts for each nostril, we assessed the average inspiratory resistance for each nostril separately.
The plethysmography took place on the Master Screen Body of VIASYS, the door of the Body was closed as well as all the doors of the room and without the presence of motion in the test room. The subject performed calm breaths with a closed nose, through the mouthpiece and then took a deep breath, followed by deep exhalation. At the end of the effort we had values for the total lung capacity (TLC), residual volume (RV), airway resistance (R), vital capacity (VC), the functional residual capacity (FRC), Exhaled residual volume (ERV) and the ratio RV / TLC. This was repeated 3 times and one was selected to be the most representative.
The P.100 was performed through the Master Screen Body of VIASYS with the door of the Body Box opened. The volunteer was performing calm breaths with a closed nose, through the mouthpiece, during which a shutter blocked the flow. The obtained value of the pressure was the one that developed in the first second of inhalation with the shutter down is noted. This repeated 3 times and one selected to be the most representative.
Spirometry and the flow-volume curve were assessed with a Master Screen Body of VIASYS with the door of the Body Box opened as follows: The subject performed tidal breathing with a closed nose, through the mouthpiece, and then took a sharp deep breath, which was followed by sharp deep exhalation, and the test ended with deep inhalation. At the end of the effort we had values for forced vital capacity (FVC), the violent expiratory the first volume 1 (FEV1), the ratio FVC/FEV1%, peak expiratory flow (PEF) and mesoexpiratory flow in peripheral airways than 25% to 75% of vital capacity. This was repeated 3 times and one was selected to be the most representative.
The assessment of the type of breathing during exposure to secondhand smoke was performed through the VIASYS Respitrace. The protocol was as follows: The volunteer breathed calmly over 20 times with the mouth closed and once with a closed nose, while wearing two rubber bands, one on the chest and one to the abdomen, which incorporates electrodes. The waveform of the breath in the thorax, abdomen and the average of these was recorded in real time. Also, for every breath we had values for the inspiratory time, expiratory time, total time, the participation rate of the chest, the participation rate of the ventricle, the peak inspiratory flow (Pif), the mean inspiratory flow (Mif), and the flow-volume curve and the analysis chart of each breath in the thoracic and abdominal component.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Attiki
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Athens, Attiki, Greece
- Hellenic Anticancer Society
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: nasal breathing
At the time that the exposure took place with nasal breathing, the study was as follows: Before the exposure: rhinomanometry, IOS , FeNO , spirometry, plethysmography, P.100. Exposure to second hand smoking:Each volunteer was exposed to secondhand smoking twice, for 20 minutes, once with nasal breathing and once with oral breathing, with 3 days interval and in random sequence. After the exposure: rhinomanometry, IOS , FeNO , spirometry,plethysmography , P.100. |
The duration of the exposure to second hand smoke both days was for 20 minutes within a 250mgr/m3 concentration box room.
A smoking machine was used, which mimics the smoker (up to 6 breaths per minute in tobacco volume 80ml for each inhalation).
The exposure was sometimes with closed mouth and others with closed nose in random sequence.
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Experimental: oral breathing
At the time that the exposure took place with oral breathing, the study was as follows: Before the exposure: IOS, exhaled nitric oxide (FeNO), spirometry, plethysmography and P.100. Exposure to second hand smoking: each volunteer was exposed to secondhand smoking twice, for 20 minutes, once with nasal breathing and once with oral breathing, with 3 days interval and in random sequence. After the exposure: IOS, FeNO, spirometry,plethysmography and P.100. |
The duration of the exposure to second hand smoke both days was for 20 minutes within a 250mgr/m3 concentration box room.
A smoking machine was used, which mimics the smoker (up to 6 breaths per minute in tobacco volume 80ml for each inhalation).
The exposure was sometimes with closed mouth and others with closed nose in random sequence.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
exhaled nitric oxide (FeNO) for the respiratory tract
Time Frame: before exposure (Baseline) and after exposure with a 30 minutes interval
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To compare the changes between the two types of breathing
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before exposure (Baseline) and after exposure with a 30 minutes interval
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plethysmography
Time Frame: before exposure (Baseline) and after exposure with a 30 minutes interval
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plethysmography take place both at oral and nasal breathing twice before and after intervention.
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before exposure (Baseline) and after exposure with a 30 minutes interval
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eye or nose irritation
Time Frame: during the exposure to second hand smoke
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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.
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during the exposure to second hand smoke
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Panagiotis K Behrakis, Professor, National and Kapodistrian University of Athens
- Principal Investigator: Palagia M Karas, MD, National and Kapodistrian University of Athens
Publications and helpful links
General Publications
- 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):1400-1406. doi: 10.1378/chest.11-2443. Epub 2011 Dec 22.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 6322/6.3.13
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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