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

2018年4月17日 更新者:Naomi Kondo Nakagawa、University of Sao Paulo
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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

24

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Sao Paulo、巴西、1246-903
        • Faculdade de Medicina da Universidade de São Paulo
    • Minas Gerais
      • Belo Horizonte、Minas Gerais、巴西
        • Universidade Federal de Minas Gerais

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 45年 (成人)

接受健康志愿者

是的

有资格学习的性别

男性

描述

Inclusion Criteria:

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

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
实验性的:saline and sniffing
This RRC is the combination of positioning (laying down), sniffing (only one side), throat vibration and saline instillation. And then the other side.
This technique is a combination of positioning (laying down), saline instilation (5 ml in each side), sniffing (the side that received saline instilation) and throat vibration. Then the other side.
安慰剂比较:sniffing
Pacient will be in a lay down condition and will perform sniffing with throat vibration several times each side (but with no saline instillation)
This technique is a combination of positioning (laying down), sniffing (the side that received saline instilation) and throat vibration. Then the other side.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Nasal mucociliary clearance
大体时间:15 days
Saccharine transit time test.
15 days

次要结果测量

结果测量
措施说明
大体时间
Mucus physical properties
大体时间:15 days
Contact angle
15 days

其他结果措施

结果测量
措施说明
大体时间
Upper airway symptoms
大体时间:15 days
Sinonasal Outcome Questionnaire -20
15 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Paulo HN Saldiva, PhD、University of Sao Paulo

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年7月1日

初级完成 (实际的)

2012年8月1日

研究完成 (实际的)

2012年8月1日

研究注册日期

首次提交

2013年6月18日

首先提交符合 QC 标准的

2018年4月17日

首次发布 (实际的)

2018年4月27日

研究记录更新

最后更新发布 (实际的)

2018年4月27日

上次提交的符合 QC 标准的更新

2018年4月17日

最后验证

2018年4月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • CEP-FMUSP 221/11

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

健康态度的临床试验

saline and sniffing的临床试验

3
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