Clinical Trials Directory

Trials / Completed

CompletedNCT03510585

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
24 (actual)
Sponsor
University of Sao Paulo · Academic / Other
Sex
Male
Age
18 Years – 45 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
OTHERsaline and sniffingThis 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.
OTHERsniffingThis technique is a combination of positioning (laying down), sniffing (the side that received saline instilation) and throat vibration. Then the other side.

Timeline

Start date
2012-07-01
Primary completion
2012-08-01
Completion
2012-08-01
First posted
2018-04-27
Last updated
2018-04-27

Locations

2 sites across 1 country: Brazil

Source: ClinicalTrials.gov record NCT03510585. Inclusion in this directory is not an endorsement.