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SmokingNCT02136550

Smoking Cessation on the Human Airway: Mucus Secretion, Inflammatory and Proteomic Profile in Nose and miRNAs in Blood

A study testing Smoking cessation in people with Smoking and Smoking Cessation, run by University of Sao Paulo at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Smoking cessation improves health conditions with reduction of the risk factors for cardiovascular and respiratory disease, as functional capacity and quality of life. Smoking cessation has positive effects on the miRNAs regulation, however, genomics has been little explored. Smoking and aging induces changes miRNAs. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Smoking, Smoking Cessation
What is being tested?
Smoking cessation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteBrazil
Study dates
Feb 2013to Nov 2018
Phase
Interventional
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 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 36 subjects, male or female, aged between 18 and 70 years recruited at Medical School University of Sao Paulo and the Smoking Cessation Program of the Clinics Hospital

Who cannot join

  • inability to taste saccharin, nasal surgery, infection in the last 30 days (before the study)

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Faculdade de Medicina da Universidade de Sao Paulo

    São Paulo, 01246-903

Other trials in Brazil

About this study

Official title: Smoking Cessation on the Human Airway: Mucus Secretion, Inflammatory and Proteomic Profile in Nasal Lavage and miRNAs in Blood

Smoking cessation improves health conditions with reduction of the risk factors for cardiovascular and respiratory disease, as functional capacity and quality of life. Smoking cessation has positive effects on the miRNAs regulation, however, genomics has been little explored. Smoking and aging induces changes miRNAs. Among the changes in airway epithelial cells, miR-125 called attention because it is enrolled in the suppression of ERBB7 (tirosin kinase receptors), a codified sequence of the growth factor receptor (EGFR) frequently expressed in cancer. The reduction of miR-125 expression may reduce cancer suppression resulting in cancer development. Other miRNA changes can be observed, such as miR-218 that were found in smokers airway epithelial cells as in MiR-15b that were found in lung tissue of COPD smokers. These miRNAs participated in the signalling pathway of TGF-β enrolled in leukocyte migration and cell proliferation. The investigators hypothesize that smoking cessation has a role in the regulation or reduction in the genetic changes smoking-induced. The investigators will assess the subject genomic profile at the baseline, 6 months and 12 months after smoking cessation.

Read the detailed description

After agreement with the written informed consent, 36 volunteers, male and female, aged between 18 and 70 years will be recruited at Medical School University of Sao Paulo and in the Ambulatory of Smoking Cessation Program of the Clinics Hospital. Exclusion criteria are inability to taste saccharin, nasal surgery, respiratory infection in the previous 30 days to the enrollement into the study. All volunteers will be assessed at Basal, 6 months and 12 months. The present study aims to assess the effects of smoking cessation on the airway defense mechanism, airway inflammation and genomics (miRNAs) in humans by using (a) saccharin transit time test to assess mucociliary clearance; (b) mucus physical properties; (c) EBC pH; (d) Nasal lavage pH, cellularity,cytokines (IL-1β, TGF-β, TNF-α, IL-4, IL-6, IL-8, IL-10, IL-13, MPO, MUC5AC, cotinine, proteomics, (e) lung function; (f) genomics (miRNAs) and (g) quality of life with rhinosinusitis questionnaire (SNOT20), sleep disturbances questionnaire.

Being tested
Smoking cessation
Keywords
smoking, smoking cessation, mucociliary clearance, proteomics, miRNA
Medical subject headings
Smoking, Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Smoking cessationBehavioural

    Smoking cessation is a program that gives all the support to the subject: orientation, medications, exams, etc

Study groups in NCT02136550
Study groupRoleWhat they receive
Smoking cessationExperimental36 smokers will participate in the study and will be evaluated at baseline, 6 months e 12 months of the smoking cessation program. If they quit the program, they will be asked to continue the study.
Receives: Behavioral: Smoking cessation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. miRNAs expression

    Blood sample will be collected in paxgene tube (BD do Brasil, SP, Brasil). MicroRNAs will be extracted from the blood samples by using PAXgene blood miRNA kit (Qiagen Inc., Valencia, USA). PCR Array will be customized (Custom miScript miRNA PCR Array, Qiagen Inc., Valencia, USA) for the miRNAs analysis. The fluorescence signal will be detected by RotorGene (Qiagen Inc., Valencia, USA).

    Measured: PParticipants will be followed for the duration of the cessation program, an expected average of 6 months

Secondary outcomes (6)

  1. saccharin transit time test

    We evaluate the nasal MCC by measuring nasal saccharine transport time (STT). The subject is asked to avoid alcohol, tea and coffee for 6 hours and to eat or drink nothing for 2 hours before the measurements. The STT assessment is performed in a quiet room at a temperature of 21-22ºC and relative humidity of 63-71%. Subjects sat in a chair and are asked to maintain regular breathing, to avoid deep breathing, coughing, sneezing, sniffing or talking during STT measurements. Twenty-five µg saccharin particles are deposited 2 cm from the anterior end of the non-obstructed nostril and the timer is stopped at the first perception of sweet taste. The maximum delay between the deposition and perception is set at 60 minutes for non-detection.

    Measured: Participants will be followed for the duration of the cessation program, an expected average of 6 months

  2. Airway acidification by exhaled breath condensate pH

    The EBC is obtained as previously described. At the start of EBC collection, all subjects rinse their mouths with distilled water and are instructed to swallow saliva as necessary and to hold a slight head extension (approximately 15o). The EBC sample is collected over 15 min of quiet and normal breathings (regular tidal volumes and respiratory rate) through a mouthpiece that is connected to a collector device with dry ice (-20 °C). The total EBC (2.0-2.5 ml) is immediately divided and transferred to sterile 500 μl polypropylene tubes. One aliquot is immediately used for pH measurements. The remaining EBC sample aliquots are coded (for blinding purposes) and stored for a maximum of 4 weeks at -80°C for the determination of cytokine levels.

    Measured: Participants will be followed for the duration of the cessation program, an expected average of 6 months

  3. Quality of life by St George Questionnaire

    This is a questionnaire validate for Brazilian population to assess the quality of life of individuals with chronic respiratory problems (de Souza et al, 2000)

    Measured: Participants will be followed for the duration of the cessation program, an expected average of 6 months

  4. inflammation in the upper airway by analysis of nasal lavage

    Celularity and determination of TNF-α, IL-1beta, IL1-RA, IL-4, IL-5, IL-6, IL-8, IL-9, IL-10, IL-13, IL-17, MPO, G-CSF, MUC5AC and cotinine (multiplex bead assay and ELISA) in nasal lavage. Celularity: the cell pellet is resuspended in one milliliter of phosphate buffer saline solution (PBS). Thereafter, 20 µl of the mixed solution is added to a Neubauer chamber, and the cells are counted using a 400x light microscope (Olympus CH2, Olympus America Inc., Palo Alto, USA). For differential cell counts, 100 µl of the mixed solution is centrifuged (96 g, 25°C, 6 min) to obtain a slide with two areas of cells that are stained with hematoxylin and eosin. Differential cell counts are performed with the aid of a 1000x light microscope (Olympus CH2, Olympus America Inc., Palo Alto, USA) by two different observers.

    Measured: Participants will be followed for the duration of the cessation program, an expected average of 6 months

  5. Upper airways symptoms by SNOT20 questionnaire

    This is a questionnaire that aims to assess quality of life of patients with chronic upper airways symptoms

    Measured: Participants will be followed for the duration of the cessation program, an expected average of 6 months

  6. sleep quality by Pittsburg questionnaire

    It is a questionnaire to assess the quality of sleep (basically 6 questions)

    Measured: Participants will be followed for the duration of the cessation program, an expected average of 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2014 (estimated)
  2. Study startFeb 2013
  3. Primary completionDec 2015
  4. Study completionNov 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Model description
Subjects that entered in the Smoking Cessation Program at Institute Dante Pazzanese of Cardiology State of Sao Paulo
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02136550
Sponsor's protocol ID
CEP 147/13
Other IDs
FAPESP 2013/13598-1
Status last verified
Apr 2018
First submitted
6 May 2014
Last updated
19 Apr 2018
Results posted
No
Data monitoring committee
No

Publications

  • Utiyama DM, Yoshida CT, Goto DM, de Santana Carvalho T, de Paula Santos U, Koczulla AR, Saldiva PH, Nakagawa NK. The effects of smoking and smoking cessation on nasal mucociliary clearance, mucus properties and inflammation. Clinics (Sao Paulo). 2016 Jul;71(6):344-50. doi: 10.6061/clinics/2016(06)10.

    PubMed 27438569

Questions about this trial

What is this clinical trial studying?

A study testing Smoking cessation in people with Smoking and Smoking Cessation, 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Apr 2018. 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?

Results are not available in the source record.

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?

miRNAs expression (time frame: PParticipants will be followed for the duration of the cessation program, an expected average of 6 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 NCT02136550, which also lists 1 linked publication.

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 19 Apr 2018.

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