Young Smokers Have Impaired Airway Defense

NCT01877291 | Completed DMC

• 1 other identifier: CEP-FMUSP 147-13
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking

Keywords

smoking, nasal lavage, exhaled breath condensate, mucociliary transport

Outcome Measures

Primary Outcomes (1)

• Exhaled Breath Condensate pH

  six months

Secondary Outcomes (1)

• mucociliary clearance by saccharine transit time test

  six months

Other Outcomes (1)

• cytokines in nasal lavage

  six months

Study Arms (3)

Nonsmokers

Young healthy nonsmokers

Smokers<2.5 pack years

Young "healthy" or asymptomatic smokers (aged \< 35 y.o.) with smoking history \<2.5 pack years

Smokers≥ 2.5 pack-years

Young "healthy" or asymptomatic smokers (aged \< 35 y.o.) with smoking history ≥ 2.5 pack-years

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, Brazil

Location

Related Publications (2)

• 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.

  BACKGROUND

• 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.

  PMID: 24307008 DERIVED

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Naomi K Nakagawa

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, MSc, PhD

Study Record Dates

• First Submitted: June 11, 2013
• First Posted: June 13, 2013
• Study Start: April 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: November 1, 2012
• Last Updated: June 17, 2013

Record last verified: 2013-06

Locations

BR (1)