跳至主要内容
临床试验/NCT03510585
NCT03510585已完成不适用

Mucociliary Clearance, Airway Inflammation and Nasal Symptoms in Urban Motorcycle-drivers

University of Sao Paulo3 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2012年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
3
主要终点
Nasal mucociliary clearance

研究概览

简要总结

Professionals working in polluted areas may present increased airways symptoms and dysfunction. Rhinopharyngeal retrograde clearance (RRC) has been used to improve mucus clearance in infants with bronchitis and bronchiolitis. Flushing the nasal cavity with saline (S) has been used to reduce nasal inflammation in rhinitis and sinupathies. The aim of this study was to assess the effects of RRC and RRC plus S (RRC+S) on the airways in professional motorcyclists. Twenty-four male motorcyclists (mean age 36 years) were randomly assigned to RRC or RRC+S. Subjects were assessed at baseline and 15 days after interventions for airways assessments by saccharin test, mucus contact angle, cellularity in nasal lavage and airways symptoms with the use of SNOT-20 questionnaire. Data were analyzed by nonparametric ANOVA for repeated measures with Bonferroni´s correction. A passive nitrogen dioxide monitoring system was used to assess the mean personal air pollution exposure along the study period (NO2). The association between NO2 and the airways outcomes was analyzed by Spearman correlation test. At baseline, the two groups were similar in clinical, demographics and working aspects. From them, 100% had airways symptoms complaints and 33% had nasal MCC impairment. After treatments, both groups presented improvements in airways symptoms and nasal MCC. However, increased number of macrophages and ciliated cells were observed in nasal lavage of both groups. No associations between nitrogen dioxide and the outcome variables were detected. Rhinopharyngeal retrograde clearance seems to be useful in the clinical management of the upper airways symptoms and dysfunction in adults.

详细描述

The nonsmokers subjects aged 18 years to 45 years were enrolled in this study after agreement with the written informed consent. Subjects were randomly assigned to 15-days of one of the following interventions: RRC and RRC+S. Non pharmacological respiratory approaches may be useful in the management of the respiratory symptoms and dysfunctions air pollution-related. The purpose of this study was to determine whether saline instillation and/or retrograde rhinopharyngeal retrograde clearance are effective in the treatment of upper airways dysfunction through nasal mucociliary clearance, mucus properties, pH, cellularity and cytokines in nasal lavage and pH in exhaled breath condensate, as well as the airways symptoms (cough, wheeze, runny nose, hoarseness, among others) in motorcyclists due to urban air pollution.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Professional motorcyclists aged 18 years to 45 years
  • Agreement with the written informed consent

排除标准

  • inability to understand and to follow commands,
  • previous nasal surgery,
  • respiratory infection in the previous 30 days

研究组 & 干预措施

saline and sniffing

Experimental

This RRC is the combination of positioning (laying down), sniffing (only one side), throat vibration and saline instillation. And then the other side.

干预措施: saline and sniffing (Other)

sniffing

Placebo Comparator

Pacient will be in a lay down condition and will perform sniffing with throat vibration several times each side (but with no saline instillation)

干预措施: sniffing (Other)

结局指标

主要结局

Nasal mucociliary clearance

时间窗: 15 days

Saccharine transit time test.

次要结局

  • Mucus physical properties(15 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Naomi Kondo Nakagawa

Associate Professor of Faculdade de Medicina da Universidade de São Paulo

University of Sao Paulo

研究点 (3)

Loading locations...

相似试验