- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01976039
Rhinopharyngeal Retrograde Clearance is Effective to Adequate Upper Airways Function in Adults
April 17, 2018 updated by: Naomi Kondo Nakagawa, University of Sao Paulo
The Effectiveness of Rhinopharyngeal Retrograde Clearance on the Upper Airways Symptomatology and Function in Adults
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
São Paulo, Brazil, 1246-903
- Faculdade de Medicina da Universidade de Sao Paulo
-
-
Minas Gerais
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Belo Horizonte, Minas Gerais, Brazil, 31270-901
- Universidade Federal de Minas Gerais
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: RRC
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.
|
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
Other Names:
|
Experimental: RRC+S
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).
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
15 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mucus surface property
Time Frame: 15 days
|
The contact angle of nasal mucus was measured.
|
15 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SNOT-20
Time Frame: 15 days
|
A questionnaire to assess the symptoms of the nose and airways for rhinosinusitis
|
15 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Naomi K Nakagawa, PhD, University of Sao Paulo
- Study Director: Paulo HN Saldiva, PhD, University of Sao Paulo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
October 29, 2013
First Submitted That Met QC Criteria
November 4, 2013
First Posted (Estimate)
November 5, 2013
Study Record Updates
Last Update Posted (Actual)
April 19, 2018
Last Update Submitted That Met QC Criteria
April 17, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEP-FMUSP 211-11
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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