- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01877291
Young Smokers Have Impaired Airway Defense
Young Smokers Have Impaired Airway Defense That is Not Associated With Pulmonary Function
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
SP
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São Paulo, SP, Brazil
- Faculdade de Medicina da Universidade de Sao Paulo
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Nonsmokers
Young healthy nonsmokers
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Smokers<2.5 pack years
Young "healthy" or asymptomatic smokers (aged < 35 y.o.) with smoking history <2.5 pack years
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Smokers≥ 2.5 pack-years
Young "healthy" or asymptomatic smokers (aged < 35 y.o.) with smoking history ≥ 2.5 pack-years
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Exhaled Breath Condensate pH
Time Frame: six months
|
six months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
mucociliary clearance by saccharine transit time test
Time Frame: six months
|
six months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
cytokines in nasal lavage
Time Frame: six months
|
six months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Naomi K Nakagawa, University of Sao Paulo
Publications and helpful links
General Publications
- Rubin BK, Ramirez O, Zayas JG, Finegan B, King M. Respiratory mucus from asymptomatic smokers is better hydrated and more easily cleared by mucociliary action. Am Rev Respir Dis. 1992;145(3):545-547. Konrad F, Schreiber T, Brecht-Kraus D, Georgieff M. Mucociliary transport in ICU patients. Chest. 1994;105(1):237-241. Kim JS, Rubin BK. Nasal and sinus involvement in chronic obstructive pulmonary disease. Curr Opin Pulm Med 2008;14(2):101-104. Miller MR, Crapo R, Hankinson J, Brusasco V, Burgos F, Casaburi R, et al. General considerations for lung function testing. Eur. Respir. J. 2005;26: 153-161. Oliveira-Maul JP, de Carvalho HB, Goto DM, Maia RM, Fló C, Barnabé V, Franco DR, Benabou S, Perracini MR, Jacob-Filho W, Saldiva PHN, Lorenzi-Filho G, Rubin BK, Nakagawa NK. Aging, diabetes, and hypertension are associated with decreased nasal mucociliary clearance. Chest. 2013;143(4):1091-1097. Rubin BK, Druce H, Ramirez OE, Palmer R. Effect of clarithromycin on nasal mucus properties in healthy subjects and in patients with purulent rhinitis. Am J Respir Crit Care Med. 1997;155(6):2018-2023. Davis MD, Hunt J. Exhaled breath condensate pH assays. Immunol Allergy Clin North Am. 2012;32(3):377-386. Belda J, Parameswaran K, Keith PK, Hargreave FE. Repeatability and validity of cell and fluid-phase measurements in nasal fluid: a comparison of two methods of nasal lavage. Clin Exp Allerg. 2001;31(7):1111-1115. Koczulla AR, Noeske S, Herr C, Jörres RA, Römmelt H, Vogelmeier C, Bals R. Acute and chronic effects of smoking on inflammation markers in exhaled breath condensate in current smokers. Respiration. 2010;79(1):61-67. Nakagawa NK, Franchini ML, Driusso P, Oliveira LR, Saldiva PHN, Lorenzi-Filho G. Mucociliary clearance is impaired in acutely ill patients. Chest. 2005;128(4):2772-2777.
- 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.
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
- CEP-FMUSP 147-13
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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