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Clinical Trials/NCT03510585
NCT03510585CompletedNot Applicable

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

University of Sao Paulo2 sites in 1 country24 target enrollmentStarted: July 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
24
Locations
2
Primary Endpoint
Nasal mucociliary clearance

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

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.

Intervention: 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)

Intervention: sniffing (Other)

Outcomes

Primary Outcomes

Nasal mucociliary clearance

Time Frame: 15 days

Saccharine transit time test.

Secondary Outcomes

  • Mucus physical properties(15 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Naomi Kondo Nakagawa

Associate Professor of Faculdade de Medicina da Universidade de São Paulo

University of Sao Paulo

Study Sites (2)

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