Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
72 participants
OBSERVATIONAL
2012-04-30
2012-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinical Features and Airways Inflammation in Never Smokers and Smokers With COPD
NCT03274791
Clinical Features of Smoker Patients With Chronic Obstructive Pulmonary Disease
NCT04711629
Bronchial Infection in Patients With COPD and Frequent Exacerbations.
NCT03259022
EFFECT OF SMOKING ON MUCUS HYPERSECRETION MECHANISMS IN ASTHMA AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE
NCT01947218
A Study to Obtain Normal Values of Inflammatory Variables From Healthy Subjects
NCT00848406
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Nonsmokers
Young healthy nonsmokers
No interventions assigned to this group
Smokers<2.5 pack years
Young "healthy" or asymptomatic smokers (aged \< 35 y.o.) with smoking history \<2.5 pack years
No interventions assigned to this group
Smokers≥ 2.5 pack-years
Young "healthy" or asymptomatic smokers (aged \< 35 y.o.) with smoking history ≥ 2.5 pack-years
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* asymptomatic smokers
* after obtaining written informed consent
Exclusion Criteria
* previous nasal surgery
* respiratory infection in the previous 30 days
* reported or diagnosed asthma
18 Years
35 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fundação de Amparo à Pesquisa do Estado de São Paulo
OTHER_GOV
University of Sao Paulo
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Naomi Kondo Nakagawa
PT, MSc, PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Naomi K Nakagawa
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CEP-FMUSP 147-13
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.