The Protective Role of the Nose During Acute Exposure to Passive Smoking.

NCT01988467 | Completed Phase 1 DMC

• 1 other identifier: 6322/6.3.13
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Second Hand Smoke Exposure

Keywords

nasal breathing, oral breathing, secondhand smoking,

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

• Eye or nose irritation

  during the exposure to second hand smoke

Study Arms (2)

nasal breathing

EXPERIMENTAL

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.

Other: exposure to second hand smoking

oral breathing

EXPERIMENTAL

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.

Other: exposure to second hand smoking

Interventions

exposure to second hand smoking OTHER

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.

nasal breathing; oral breathing

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy volunteer adults non-smokers

You may not qualify if:

• \< 18 years old
• Recent or chronic disease of the upper or lower respiratory system.
• Current pregnancy
• Breastfeeding women

Sponsors & Collaborators

• Hellenic Anticancer Society: lead
• National and Kapodistrian University of Athens: collaborator

Study Sites (1)

Hellenic Anticancer Society

Athens, Attica, Greece

Location

Related Publications (2)

• 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.

  PMID: 23205567 BACKGROUND

• 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.

  PMID: 22194587 BACKGROUND

Study Officials

• Panagiotis K Behrakis, Professor

  National and Kapodistrian University of Athens

  STUDY CHAIR

• Palagia M Karas, MD

  National and Kapodistrian University of Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: November 20, 2013
• Study Start: August 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: July 1, 2013
• Last Updated: November 20, 2013

Record last verified: 2013-11

Locations

GR (1)