Mucociliary Clearance, Airway Inflammation and Nasal Symptoms in Urban Motorcycle-drivers
April 17, 2018 updated by: 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Sao Paulo, Brazil, 1246-903
- Faculdade de Medicina da Universidade de Sao Paulo
-
-
Minas Gerais
-
Belo Horizonte, Minas Gerais, Brazil
- Universidade Federal de Minas Gerais
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
|
Placebo Comparator: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nasal mucociliary clearance
Time Frame: 15 days
|
Saccharine transit time test.
|
15 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mucus physical properties
Time Frame: 15 days
|
Contact angle
|
15 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Upper airway symptoms
Time Frame: 15 days
|
Sinonasal Outcome Questionnaire -20
|
15 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Paulo HN Saldiva, PhD, University of Sao Paulo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
June 18, 2013
First Submitted That Met QC Criteria
April 17, 2018
First Posted (Actual)
April 27, 2018
Study Record Updates
Last Update Posted (Actual)
April 27, 2018
Last Update Submitted That Met QC Criteria
April 17, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEP-FMUSP 221/11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.