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Trial record 14 of 2035 for:    Smoking Cessation

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

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ClinicalTrials.gov Identifier: NCT02136550
Recruitment Status : Active, not recruiting
First Posted : May 13, 2014
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
Naomi Kondo Nakagawa, University of Sao Paulo

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Smoking Smoking Cessation Behavioral: Smoking cessation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Subjects that entered in the Smoking Cessation Program at Institute Dante Pazzanese of Cardiology State of Sao Paulo
Masking: None (Open Label)
Masking Description: Fluid analysis and other physical measurements
Primary Purpose: Screening
Official Title: Smoking Cessation on the Human Airway: Mucus Secretion, Inflammatory and Proteomic Profile in Nasal Lavage and miRNAs in Blood
Study Start Date : February 2013
Actual Primary Completion Date : December 2015
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Smoking cessation
36 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.
Behavioral: Smoking cessation
Smoking cessation is a program that gives all the support to the subject: orientation, medications, exams, etc




Primary Outcome Measures :
  1. miRNAs expression [ Time Frame: PParticipants will be followed for the duration of the cessation program, an expected average of 6 months ]
    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).


Secondary Outcome Measures :
  1. saccharin transit time test [ Time Frame: Participants will be followed for the duration of the cessation program, an expected average of 6 months ]
    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.

  2. Airway acidification by exhaled breath condensate pH [ Time Frame: Participants will be followed for the duration of the cessation program, an expected average of 6 months ]
    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.

  3. Quality of life by St George Questionnaire [ Time Frame: Participants will be followed for the duration of the cessation program, an expected average of 6 months ]
    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)

  4. inflammation in the upper airway by analysis of nasal lavage [ Time Frame: Participants will be followed for the duration of the cessation program, an expected average of 6 months ]
    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.

  5. Upper airways symptoms by SNOT20 questionnaire [ Time Frame: Participants will be followed for the duration of the cessation program, an expected average of 6 months ]
    This is a questionnaire that aims to assess quality of life of patients with chronic upper airways symptoms

  6. sleep quality by Pittsburg questionnaire [ Time Frame: Participants will be followed for the duration of the cessation program, an expected average of 6 months ]
    It is a questionnaire to assess the quality of sleep (basically 6 questions)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02136550


Locations
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Brazil
Faculdade de Medicina da Universidade de Sao Paulo
Sao Paulo, Brazil, 01246-903
Sponsors and Collaborators
University of Sao Paulo
Investigators
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Study Director: Paulo HN Saldiva, Professor University of Sao Paulo Medical School
Principal Investigator: Naomi K. Nakagawa, Professor University of Sao Paulo Medical School

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Naomi Kondo Nakagawa, Associate Professor of Physiotherapy, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02136550     History of Changes
Other Study ID Numbers: CEP 147/13
FAPESP 2013/13598-1 ( Other Grant/Funding Number: FAPESP 2013/13598-1 )
First Posted: May 13, 2014    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018

Keywords provided by Naomi Kondo Nakagawa, University of Sao Paulo:
smoking
smoking cessation
mucociliary clearance
proteomics
miRNA