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

NCT02136550 | Unknown

• 2 other identifiers: CEP 147/13FAPESP 2013/13598-1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking; Smoking Cessation

Keywords

smoking; smoking cessation; mucociliary clearance; proteomics; miRNA

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (6)

• saccharin transit time test

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

• Airway acidification by exhaled breath condensate pH

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

• Quality of life by St George Questionnaire

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

• inflammation in the upper airway by analysis of nasal lavage

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

• Upper airways symptoms by SNOT20 questionnaire

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

Study Arms (1)

Smoking cessation

EXPERIMENTAL

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

Interventions

Smoking cessation BEHAVIORAL

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

Smoking cessation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, 01246-903, Brazil

Location

Related Publications (1)

• 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.

  PMID: 27438569 DERIVED

MeSH Terms

Conditions

Smoking; Smoking Cessation

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Study Officials

• Paulo HN Saldiva, Professor

  University of Sao Paulo Medical School

  STUDY DIRECTOR

• Naomi K. Nakagawa, Professor

  University of Sao Paulo Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Fluid analysis and other physical measurements
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physiotherapy

Model Details: Subjects that entered in the Smoking Cessation Program at Institute Dante Pazzanese of Cardiology State of Sao Paulo

Study Record Dates

• First Submitted: May 6, 2014
• First Posted: May 13, 2014
• Study Start: February 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: November 1, 2018
• Last Updated: April 19, 2018

Record last verified: 2018-04

Locations

BR (1)