Smoking Cessation on the Human Airway: Mucus Secretion, Inflammatory and Proteomic Profile in Nasal Lavage and miRNAs in Blood
试验速览
- 阶段
- 不适用
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- miRNAs expression
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
盲法说明
Fluid analysis and other physical measurements
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •inability to taste saccharin, nasal surgery, infection in the last 30 days (before the study)
结局指标
主要结局
miRNAs expression
时间窗: 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).
次要结局
- 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)
- 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)
- Quality of life by St George Questionnaire(Participants will be followed for the duration of the cessation program, an expected average of 6 months)
- sleep quality by Pittsburg questionnaire(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)
研究者
Naomi Kondo Nakagawa
Associate Professor of Physiotherapy
University of Sao Paulo