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OpenTrials
Completed

NCT Number: NCT01877291

Young Smokers Have Impaired Airway Defense

Background: Smoking is a key factor for development and progression of chronic obstructive pulmonary disease (COPD). Although persons with COPD often have concomitant nasal disease, there are few studies that report physiological or inflammatory changes in the upper airways in young asymptomatic smokers. The investigators investigated physiologic and inflammatory changes in the nasal and lower airways of young smokers and if these changes were related to smoking history.

Methods: Seventy-two subjects aged ≤ 35 years (32 healthy nonsmokers and 40 young smokers) participated in this study. The investigators measured nasal mucociliary clearance (MCC), nasal mucus physical properties, cell count, myeloperoxidase and cytokines concentrations in nasal lavage fluid, exhaled breath condensate (EBC) pH and lung function.

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Key information

Conditions

Smoking Behavior

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculdade de Medicina da Universidade de São Paulo

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy nonsmokers
  • asymptomatic smokers
  • after obtaining written informed consent

Exclusion criteria

  • inability to understand and follow commands
  • previous nasal surgery
  • respiratory infection in the previous 30 days
  • reported or diagnosed asthma

Treatment and study plan

Primary outcomes

  1. Exhaled Breath Condensate pH

    Time frame: six months

Secondary outcomes

  1. mucociliary clearance by saccharine transit time test

    Time frame: six months

Other outcomes

  1. cytokines in nasal lavage

    Time frame: six months

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Young Smokers Have Impaired Airway Defense That is Not Associated With Pulmonary Function

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 13, 2013
Registry last updated
Jun 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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