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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01976039
Other study ID # CEP-FMUSP 211-11
Secondary ID
Status Completed
Phase N/A
First received October 29, 2013
Last updated April 17, 2018
Start date July 2012
Est. completion date August 2012

Study information

Verified date April 2018
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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 with the aid of saline instillation

Locations

Country Name City State
Brazil Universidade Federal de Minas Gerais Belo Horizonte Minas Gerais
Brazil Faculdade de Medicina da Universidade de São Paulo São Paulo

Sponsors (3)

Lead Sponsor Collaborator
University of Sao Paulo Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (6)

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. — View Citation

Cançado 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. Review. Portuguese. — View Citation

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. Epub 2012 Apr 12. — View Citation

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. — View Citation

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. — View Citation

Proença de Oliveira-Maul J, Barbosa de Carvalho H, Goto DM, Maia RM, Fló C, Barnabé 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other SNOT-20 A questionnaire to assess the symptoms of the nose and airways for rhinosinusitis 15 days
Primary 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 mucus surface property The contact angle of nasal mucus was measured. 15 days
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