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Rhinopharyngeal Retrograde Clearance is Effective to Adequate Upper Airways Function in Adults

This study has been completed.
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Naomi Kondo Nakagawa, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01976039
First received: October 29, 2013
Last updated: November 4, 2013
Last verified: October 2013
  Purpose
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.

Condition Intervention
Nasal Obstruction
Exposure to Pollution
Other: rhinopharyngeal retrograde clearance (RRC)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness of Rhinopharyngeal Retrograde Clearance on the Upper Airways Symptomatology and Function in Adults

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Saccharine transit time test (STT) [ Time Frame: 15 days ]
    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.


Secondary Outcome Measures:
  • mucus surface property [ Time Frame: 15 days ]
    The contact angle of nasal mucus was measured.


Other Outcome Measures:
  • SNOT-20 [ Time Frame: 15 days ]
    A questionnaire to assess the symptoms of the nose and airways for rhinosinusitis


Enrollment: 24
Study Start Date: July 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RRC
rhinopharyngeal retrograde clearance (RRC) isolated
Other: rhinopharyngeal retrograde clearance (RRC)
The rhinopharyngeal retrograde clearance is a respiratory physical therapy technique that uses a forced inspiratory maneuver to clear the nasopharynx
Experimental: RRC+S
retrograde rhinopharyngeal retrograde clearance combined with saline instillation (RRC+S)
Other: rhinopharyngeal retrograde clearance (RRC)
The rhinopharyngeal retrograde clearance is a respiratory physical therapy technique that uses a forced inspiratory maneuver to clear the nasopharynx

Detailed Description:
Male motorcyclists (mean age 36 years) were recruited and randomly assigned to RRC or RRC+S. Subjects were assessed at baseline and 15 days after interventions for saccharin test, mucus contact angle, cellularity in nasal lavage and airways symptoms with the use of SNOT-20 questionnaire. Data were analyzed by two-way ANOVA for repeated measures with Bonferroni´s correction. A passive monitoring-system of nitrogen dioxide was used to assess the individual air pollution exposure along the study period. The association between nitrogen dioxide and the airways outcomes was analyzed by Spearman correlation test.
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Smokers
  • Inability to understand and to follow commands
  • Previous nasal surgery
  • Respiratory infection in the previous 30 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01976039

Locations
Brazil
Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil, 31270-901
Faculdade de Medicina da Universidade de São Paulo
São Paulo, Brazil, 1246-903
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Principal Investigator: Naomi K Nakagawa, PhD University of Sao Paulo
Study Director: Paulo HN Saldiva, PhD University of Sao Paulo
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Naomi Kondo Nakagawa, Associate Professor of Faculdade de Medicina da Universidade de São Paulo, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01976039     History of Changes
Other Study ID Numbers: CEP-FMUSP 211-11
Study First Received: October 29, 2013
Last Updated: November 4, 2013

Keywords provided by University of Sao Paulo:
motorcyclist
nasal mucociliary clearance
physical therapy

Additional relevant MeSH terms:
Nasal Obstruction
Nose Diseases
Respiratory Tract Diseases
Airway Obstruction
Respiratory Insufficiency
Respiration Disorders
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on March 28, 2017