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

NCT03510585 | Completed DMC

• 1 other identifier: CEP-FMUSP 221/11
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Attitude to Health

Keywords

mucociliary clearance; air pollution; nasal lavage; exhaled breath condensate; inflammation

Outcome Measures

Primary Outcomes (1)

• Nasal mucociliary clearance

  Saccharine transit time test.

  15 days

Secondary Outcomes (1)

• Mucus physical properties

  15 days

Other Outcomes (1)

• Upper airway symptoms

  15 days

Study Arms (2)

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.

Other: saline and sniffing

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)

Other: sniffing

Interventions

saline and sniffing OTHER

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.

saline and sniffing

sniffing OTHER

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

sniffing

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Professional motorcyclists aged 18 years to 45 years
• Agreement with the written informed consent

You may not qualify if:

• inability to understand and to follow commands,
• previous nasal surgery,
• respiratory infection in the previous 30 days

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (2)

Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Location

Faculdade de Medicina da Universidade de São Paulo

São Paulo, 1246-903, Brazil

Location

Related Publications (1)

• Brant TC, Yoshida CT, Carvalho Tde S, Nicola ML, Martins JA, Braga LM, Oliveira RC, Leyton V, Andre CS, Saldiva PH, Rubin BK, Nakagawa NK. Mucociliary clearance, airway inflammation and nasal symptoms in urban motorcyclists. Clinics (Sao Paulo). 2014;69(12):867-70. doi: 10.6061/clinics/2014(12)13.

  PMID: 25628001 RESULT

MeSH Terms

Conditions

Inflammation

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Paulo HN Saldiva, PhD

  University of Sao Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Faculdade de Medicina da Universidade de São Paulo

Study Record Dates

• First Submitted: June 18, 2013
• First Posted: April 27, 2018
• Study Start: July 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: April 27, 2018

Record last verified: 2018-04

Locations

BR (2)