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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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REBEC |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
RBR-2h3d6b |
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Date of registration:
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04/01/2012 |
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Primary sponsor: |
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Public title:
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Effect of nebulized saline on mucociliary transport
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Scientific title:
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Effect of Nebulisation on the Mucociliary Nasal Transport
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Date of first enrolment:
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01/03/2010 |
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Target sample size:
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17 |
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Recruitment status: |
data analysis completed |
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URL:
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http://www.ensaiosclinicos.gov.br/rg/RBR-2h3d6b/ |
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Study type:
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Study design:
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Clinical Trial, Cross-over, randomized study.
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Ada
Gastaldi |
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Address:
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Av Bandeirantes n 3900
14049-900
Ribeirão Preto
Brazil |
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Telephone:
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36023058 |
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Email:
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ada@fmrp.usp.br |
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Affiliation:
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Faculdade de Medicina de Ribeirão Preto |
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Name:
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Ada
Gastaldi |
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Address:
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Av Bandeirantes n 3900
14049-900
Ribeirão Preto
Brazil |
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Telephone:
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36023058 |
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Email:
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ada@fmrp.usp.br |
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Affiliation:
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Faculdade de Medicina de Ribeirão Preto |
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Key inclusion & exclusion criteria
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Inclusion criteria: Volunteers aged between 18 and 30 years old were selected amongst the Ribeirão Preto School of Medicine undergraduate and post-graduate students for study
Exclusion criteria: Those with smoking habits, cystic fibrosis, sinusitis, rhinitis, ciliary dyskinesia, hypertrophy of lower turbinates, major septal deviation, upper and lower airways infections in the last four weeks prior to study, bronchiectasis, and individuals who underwent surgery in the upper airways were excluded from study.
Age minimum:
18Y
Age maximum:
30Y
Gender:
-
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Health Condition(s) or Problem(s) studied
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Study in healthy subjects
E01.370.386.520
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Intervention(s)
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The saccharin test is performed by measuring the time elapsed between placement of a particle of sodium saccharin into one of the nostrils and the perception of its taste. 18 patients did the test in two conditions:
First condition: Temperature and humidity controlled environment, named ENV.
Second condition: After 30 minutes of nebulization with saline using an ultrasonic nebulizer Max Breathe NS (Ind. Bras.) called NEB.
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Primary Outcome(s)
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It was expected that the nasal mucociliary transport after nebulization with saline would improve. The nasal mucociliary transport was evaluated by the saccharin test provided by the time (minutes) displacement of the particle of saccharine.
Time saccharin test
In the situation ENV: ranged from 3.1 to 8.2 minutes, with an average 5.79 minutes
In the situation NEB: ranged from 2.0 to 9.8 minutes, with an average 5.56 minutes
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Secondary ID(s)
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HCRP 13048/2009
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Source(s) of Monetary Support
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Faculdade de Medicina de Ribeirão Preto - Brazil
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