NCT01976039

Brief Summary

Professionals working in polluted areas may present increased clinical airways symptoms and dysfunction. Rhinopharyngeal retrograde clearance (RRC) has been used to improve mucus clearance in infants with bronchitis and bronchiolitis, and instillation the nasal cavity with saline has been used to reduce nasal inflammation in rhinitis and sinusopathies. The aim of this study was to assess the effects of RRC and RCC combined with saline (RRC+S) on nasal mucociliary clearance (MCC), mucus surface property, cellularity and airways symptoms in professional motorcyclists.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 5, 2013

Completed
Last Updated

April 19, 2018

Status Verified

April 1, 2018

Enrollment Period

1 month

First QC Date

October 29, 2013

Last Update Submit

April 17, 2018

Conditions

Nasal ObstructionExposure to Pollution

Keywords

motorcyclistnasal mucociliary clearancephysical therapy

Outcome Measures

Primary Outcomes (1)

  • Saccharine transit time test (STT)

    To measure nasal mucociliary clearance. Subjects were asked to report the first perception of a sweet taste after 25 mg of saccharine powder was deposited in the free airflow nostril.

    15 days

Secondary Outcomes (1)

  • mucus surface property

    15 days

Other Outcomes (1)

  • SNOT-20

    15 days

Study Arms (2)

RRC

OTHER

rhinopharyngeal retrograde clearance (RRC) isolated: First patient sits in a chair. Second: patient inhales air deeply and exhales making noise and vibration in the upper airway to facilitate swalling. Third patients finishes with another deep inhalation. This technique is new, simple to use and with no cost. No need of any material or equipment.

Other: rhinopharyngeal retrograde clearance (RRC)

RRC+S

EXPERIMENTAL

retrograde rhinopharyngeal retrograde clearance combined with saline instillation (RRC+S): patient sits in a chair and inhaled air and make noise and vibrate the upper airway at the same instills saline into the nare to facilitate nose washing and swalling. This technique is new, simple to use and with low cost (only saline).

Other: rhinopharyngeal retrograde clearance (RRC)

Interventions

rhinopharyngeal retrograde clearance (RRC)OTHER

The rhinopharyngeal retrograde clearance is a respiratory physical therapy technique that uses a forced inspiratory maneuver to clear the nasopharynx with the aid of saline instillation

Also known as: RCC+S
RRCRRC+S

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Professional motorcyclists aged 18 years to 45 years
  • Minimum of one year in that occupation
  • Agreement with the written informed consent

You may not qualify if:

  • Smokers
  • Inability to understand and to follow commands
  • Previous nasal surgery
  • Respiratory infection in the previous 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, 31270-901, Brazil

Location

Faculdade de Medicina da Universidade de São Paulo

São Paulo, 1246-903, Brazil

Location

Related Publications (7)

  • Gomes EL, Postiaux G, Medeiros DR, Monteiro KK, Sampaio LM, Costa D. Chest physical therapy is effective in reducing the clinical score in bronchiolitis: randomized controlled trial. Rev Bras Fisioter. 2012 Jun;16(3):241-7. doi: 10.1590/s1413-35552012005000018. Epub 2012 Apr 12.

    PMID: 22499404BACKGROUND

  • Proenca de Oliveira-Maul J, Barbosa de Carvalho H, Goto DM, Maia RM, Flo C, Barnabe V, Franco DR, Benabou S, Perracini MR, Jacob-Filho W, Saldiva PHN, Lorenzi-Filho G, Rubin BK, Nakagawa NK. Aging, diabetes, and hypertension are associated with decreased nasal mucociliary clearance. Chest. 2013 Apr;143(4):1091-1097. doi: 10.1378/chest.12-1183.

    PMID: 23100111BACKGROUND

  • Piccirillo JF, Merritt MG Jr, Richards ML. Psychometric and clinimetric validity of the 20-Item Sino-Nasal Outcome Test (SNOT-20). Otolaryngol Head Neck Surg. 2002 Jan;126(1):41-7. doi: 10.1067/mhn.2002.121022.

    PMID: 11821764BACKGROUND

  • Belda J, Parameswaran K, Keith PK, Hargreave FE. Repeatability and validity of cell and fluid-phase measurements in nasal fluid: a comparison of two methods of nasal lavage. Clin Exp Allergy. 2001 Jul;31(7):1111-5. doi: 10.1046/j.1365-2222.2001.01133.x.

    PMID: 11468003BACKGROUND

  • Nakagawa NK, Franchini ML, Driusso P, de Oliveira LR, Saldiva PH, Lorenzi-Filho G. Mucociliary clearance is impaired in acutely ill patients. Chest. 2005 Oct;128(4):2772-7. doi: 10.1378/chest.128.4.2772.

    PMID: 16236954BACKGROUND

  • Cancado JE, Braga A, Pereira LA, Arbex MA, Saldiva PH, Santos Ude P. [Clinical repercussions of exposure to atmospheric pollution]. J Bras Pneumol. 2006;32 Suppl 2:S5-11. doi: 10.1590/s1806-37132006000800003. Portuguese.

    PMID: 17273599BACKGROUND

  • 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: 25628001DERIVED

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesAirway ObstructionRespiratory InsufficiencyRespiration DisordersOtorhinolaryngologic Diseases

Study Officials

  • Naomi K Nakagawa, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

  • 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

October 29, 2013

First Posted

November 5, 2013

Study Start

July 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

April 19, 2018

Record last verified: 2018-04

Locations

BR(2)