Clinical trial NCT01976039: Rhinopharyngeal Retrograde Clearance is Effective to Adequate Upper Airways Function in Adults
Official title: The Effectiveness of Rhinopharyngeal Retrograde Clearance on the Upper Airways Symptomatology and Function in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Obstruction
Exposure to Pollution
Keywords: motorcyclist
nasal mucociliary clearance
physical therapy
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2013-11-05
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Saccharine transit time test (STT)
timeFrame: 15 days
Secondary outcomes:
measure: mucus surface property
timeFrame: 15 days
Other outcomes:
measure: SNOT-20
timeFrame: 15 days
Locations:
city: Belo Horizonte
country: Brazil
facility: Universidade Federal de Minas Gerais
state: Minas Gerais
city: São Paulo
country: Brazil
facility: Faculdade de Medicina da Universidade de São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Naomi K Nakagawa, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Paulo HN Saldiva, PhD
role: STUDY_DIRECTOR
References:
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citation: 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.
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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. doi: 10.1378/chest.128.4.2772.
citation: 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.
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.