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

NCT ID: NCT03510585

Last Updated: 2018-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2012-08-31

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.

Conditions

Attitude to Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

saline and sniffing

Intervention Type: 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.

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)

Group Type: PLACEBO_COMPARATOR

sniffing

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Naomi Kondo Nakagawa

Associate Professor of Faculdade de Medicina da Universidade de São Paulo

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paulo HN Saldiva, PhD

Role: STUDY_DIRECTOR

University of Sao Paulo

Locations

Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Faculdade de Medicina da Universidade de São Paulo

São Paulo, , Brazil

Countries

Brazil

References

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.

Reference Type: RESULT

PMID: 25628001 (View on PubMed)

Other Identifiers

CEP-FMUSP 221/11

Identifier Type: -

Identifier Source: org_study_id