Smoking Cessation on the Human Airway: Mucus Secretion, Inflammatory &

Status Active, not recruiting

Clinical 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. 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02136550
Study type	Interventional
Source	University of Sao Paulo
Contact
Status	Active, not recruiting
Phase	N/A
Start date	February 2013
Completion date	November 2018

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms