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

NCT ID: NCT02136550

Last Updated: 2018-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2018-11-30

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.

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.

Conditions

Smoking; Smoking Cessation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Smoking cessation

Intervention Type: BEHAVIORAL

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

Interventions

Smoking cessation

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

Intervention Type: BEHAVIORAL

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Naomi Kondo Nakagawa

Associate Professor of Physiotherapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paulo HN Saldiva, Professor

Role: STUDY_DIRECTOR

University of Sao Paulo Medical School

Naomi K. Nakagawa, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo Medical School

Locations

Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, , Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 27438569 (View on PubMed)

Other Identifiers

FAPESP 2013/13598-1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CEP 147/13

Identifier Type: -

Identifier Source: org_study_id