Clinical trial NCT01877291: Young Smokers Have Impaired Airway Defense
Official title: Young Smokers Have Impaired Airway Defense That is Not Associated With Pulmonary Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking
Keywords: smoking, nasal lavage, exhaled breath condensate, mucociliary transport
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2013-06-13
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy nonsmokers and smokers aged between 18 and 35 y.o. that were recruited from the Faculdade de Medicina da Universidade de São Paulo

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Exhaled Breath Condensate pH
timeFrame: six months
Secondary outcomes:
measure: mucociliary clearance by saccharine transit time test
timeFrame: six months
Other outcomes:
measure: cytokines in nasal lavage
timeFrame: six months
Locations:
city: São Paulo
country: Brazil
facility: Faculdade de Medicina da Universidade de São Paulo
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Naomi K Nakagawa
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Nicola ML, Carvalho HB, Yoshida CT, Anjos FMD, Nakao M, Santos UP, Cardozo KHM, Carvalho VM, Pinto E, Farsky SHP, Saldiva PHN, Rubin BK, Nakagawa NK. Young "healthy" smokers have functional and inflammatory changes in the nasal and the lower airways. Chest. 2014 May;145(5):998-1005. doi: 10.1378/chest.13-1355.