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

Attitude to Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03510585
• Other study ID #: CEP-FMUSP 221/11
• Status: Completed
• Phase: N/A
• First received: June 18, 2013
• Last updated: April 17, 2018
• Start date: July 2012
• Est. completion date: August 2012

Study information

• Verified date: April 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Attitude to Health
• Inflammation

Intervention

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

Locations

Country	Name	City	State
Brazil	Universidade Federal de Minas Gerais	Belo Horizonte	Minas Gerais
Brazil	Faculdade de Medicina da Universidade de São Paulo	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Brant TC, Yoshida CT, Carvalho Tde S, Nicola ML, Martins JA, Braga LM, Oliveira RC, Leyton V, André CS, Saldiva PH, Rubin BK, Nakagawa NK. Mucociliary clearance, airway inflammation and nasal symptoms in urban motorcyclists. Clinics (Sao Paulo). 2014;69(1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Upper airway symptoms	Sinonasal Outcome Questionnaire -20	15 days
Primary	Nasal mucociliary clearance	Saccharine transit time test.	15 days
Secondary	Mucus physical properties	Contact angle	15 days