Clinical trial NCT02136550: Smoking Cessation on the Human Airway: Mucus Secretion, Inflammatory and Proteomic Profile in Nose and miRNAs in Blood
Official title: Smoking Cessation on the Human Airway: Mucus Secretion, Inflammatory and Proteomic Profile in Nasal Lavage and miRNAs in Blood
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking
Smoking Cessation
Keywords: smoking
smoking cessation
mucociliary clearance
proteomics
miRNA
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2014-05-13
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects that entered in the Smoking Cessation Program at Institute Dante Pazzanese of Cardiology State of Sao Paulo
Primary purpose: SCREENING

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.

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)

Primary outcomes:
measure: miRNAs expression
timeFrame: PParticipants will be followed for the duration of the cessation program, an expected average of 6 months
Secondary outcomes:
measure: saccharin transit time test
timeFrame: Participants will be followed for the duration of the cessation program, an expected average of 6 months
measure: Airway acidification by exhaled breath condensate pH
timeFrame: Participants will be followed for the duration of the cessation program, an expected average of 6 months
measure: Quality of life by St George Questionnaire
timeFrame: Participants will be followed for the duration of the cessation program, an expected average of 6 months
measure: inflammation in the upper airway by analysis of nasal lavage
timeFrame: Participants will be followed for the duration of the cessation program, an expected average of 6 months
measure: Upper airways symptoms by SNOT20 questionnaire
timeFrame: Participants will be followed for the duration of the cessation program, an expected average of 6 months
measure: sleep quality by Pittsburg questionnaire
timeFrame: Participants will be followed for the duration of the cessation program, an expected average of 6 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Faculdade de Medicina da Universidade de Sao Paulo
Study officials:
affiliation: University of Sao Paulo Medical School
name: Paulo HN Saldiva, Professor
role: STUDY_DIRECTOR
affiliation: University of Sao Paulo Medical School
name: Naomi K. Nakagawa, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.