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

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ClinicalTrials.gov Identifier: NCT03510585
Recruitment Status : Completed
First Posted : April 27, 2018
Last Update Posted : April 27, 2018
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Naomi Kondo Nakagawa, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Attitude to Health Other: saline and sniffing Other: sniffing Not Applicable

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  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mucociliary Clearance, Airway Inflammation and Nasal Symptoms in Urban Motorcycle-drivers
Study Start Date : July 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

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.
Other: saline and sniffing
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)
Other: sniffing
This technique is a combination of positioning (laying down), sniffing (the side that received saline instilation) and throat vibration. Then the other side.




Primary Outcome Measures :
  1. Nasal mucociliary clearance [ Time Frame: 15 days ]
    Saccharine transit time test.


Secondary Outcome Measures :
  1. Mucus physical properties [ Time Frame: 15 days ]
    Contact angle


Other Outcome Measures:
  1. Upper airway symptoms [ Time Frame: 15 days ]
    Sinonasal Outcome Questionnaire -20



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03510585


Locations
Brazil
Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil
Faculdade de Medicina da Universidade de São Paulo
Sao Paulo, Brazil, 1246-903
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Study Director: Paulo HN Saldiva, PhD University of Sao Paulo

Publications of Results:
Responsible Party: Naomi Kondo Nakagawa, Associate Professor of Faculdade de Medicina da Universidade de São Paulo, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03510585     History of Changes
Other Study ID Numbers: CEP-FMUSP 221/11
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018

Keywords provided by Naomi Kondo Nakagawa, University of Sao Paulo:
mucociliary clearance
air pollution
nasal lavage
exhaled breath condensate
inflammation

Additional relevant MeSH terms:
Inflammation
Pathologic Processes