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

Primary Purpose

Attitude to Health

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
saline and sniffing
sniffing
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attitude to Health focused on measuring mucociliary clearance, air pollution, nasal lavage, exhaled breath condensate, inflammation

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Universidade Federal de Minas Gerais
  • Faculdade de Medicina da Universidade de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

saline and sniffing

sniffing

Arm Description

This RRC is the combination of positioning (laying down), sniffing (only one side), throat vibration and saline instillation. And then the other side.

Pacient will be in a lay down condition and will perform sniffing with throat vibration several times each side (but with no saline instillation)

Outcomes

Primary Outcome Measures

Nasal mucociliary clearance
Saccharine transit time test.

Secondary Outcome Measures

Mucus physical properties
Contact angle

Full Information

First Posted
June 18, 2013
Last Updated
April 17, 2018
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03510585
Brief Title
Mucociliary Clearance, Airway Inflammation and Nasal Symptoms in Urban Motorcycle-drivers
Official Title
Mucociliary Clearance, Airway Inflammation and Nasal Symptoms in Urban Motorcycle-drivers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attitude to Health
Keywords
mucociliary clearance, air pollution, nasal lavage, exhaled breath condensate, inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
saline and sniffing
Arm Type
Experimental
Arm Description
This RRC is the combination of positioning (laying down), sniffing (only one side), throat vibration and saline instillation. And then the other side.
Arm Title
sniffing
Arm Type
Placebo Comparator
Arm Description
Pacient will be in a lay down condition and will perform sniffing with throat vibration several times each side (but with no saline instillation)
Intervention Type
Other
Intervention Name(s)
saline and sniffing
Intervention Description
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
Intervention Name(s)
sniffing
Intervention Description
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 Measure Information:
Title
Nasal mucociliary clearance
Description
Saccharine transit time test.
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Mucus physical properties
Description
Contact angle
Time Frame
15 days
Other Pre-specified Outcome Measures:
Title
Upper airway symptoms
Description
Sinonasal Outcome Questionnaire -20
Time Frame
15 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulo HN Saldiva, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Universidade Federal de Minas Gerais
City
Belo Horizonte
State/Province
Minas Gerais
Country
Brazil
Facility Name
Faculdade de Medicina da Universidade de São Paulo
City
Sao Paulo
ZIP/Postal Code
1246-903
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
25628001
Citation
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.
Results Reference
result

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

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