SmokingNCT01877291
Young Smokers Have Impaired Airway Defense
An observational study of Smoking, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- How many people
- 72 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2012to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- healthy nonsmokers
- asymptomatic smokers
- after obtaining written informed consent
Who cannot join
- inability to understand and follow commands
- previous nasal surgery
- respiratory infection in the previous 30 days
- reported or diagnosed asthma
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo
About this study
Official title: 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.
- Conditions
- Smoking
- Keywords
- smoking, nasal lavage, exhaled breath condensate, mucociliary transport
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exhaled Breath Condensate pH
Measured: six months
Secondary outcomes (1)
mucociliary clearance by saccharine transit time test
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2013 (estimated)
- Study startApr 2012
- Primary completionOct 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Naomi Kondo Nakagawa, University of Sao Paulo
- Investigators
- Naomi K Nakagawa, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01877291
- Sponsor's protocol ID
- CEP-FMUSP 147-13
- Status last verified
- Jun 2013
- First submitted
- 11 Jun 2013
- Last updated
- 17 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 24307008
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Young Smokers Have Impaired Airway Defense That is Not Associated With Pulmonary Function
- ClinicalTrials.gov ID
- NCT01877291
- Acronym / sponsor ID
- CEP-FMUSP 147-13
- Conditions
- Smoking
- Keywords
- smoking, nasal lavage, exhaled breath condensate, mucociliary transport
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Apr 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 13 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (3 listed)
- healthy nonsmokers
- asymptomatic smokers
- after obtaining written informed consent
Key exclusion criteria (4 listed)
- inability to understand and follow commands
- previous nasal surgery
- respiratory infection in the previous 30 days
- reported or diagnosed asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Exhaled Breath Condensate pH
Time frame: six months
1 secondary outcome
mucociliary clearance by saccharine transit time test
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2013.
- BackgroundRubin 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.
- Derived from this study: PubMed 24307008Nicola 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naomi K Nakagawa principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exhaled Breath Condensate pH (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01877291, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2013.