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Measurements of Exhaled Nitric Oxide in Healthy Subjects in Thailand (FeNO_nor)

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ClinicalTrials.gov Identifier: NCT02554617
Recruitment Status : Completed
First Posted : September 18, 2015
Last Update Posted : May 3, 2016
Sponsor:
Information provided by (Responsible Party):
Nualanong Visitsunthorn, Mahidol University

Study Description
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Brief Summary:
The purpose of this study is to determine fractional exhaled nitric oxide (FeNO) level in healthy subjects among Thai populations.

Condition or disease
Normal Non-fluency

Detailed Description:

Fractional exhaled nitric oxide (FeNO) were produced from epithelial cells of inflammatory airways and eosinophils and this gas was discovered since 1991.

Fractional exhaled nitric oxide (FeNO) has direct association with severity of inflammation of bronchial trees and sputum eosinophils and use for additional investigation for diagnosis asthma or inflammatory airway diseases.

There are many factors from previous studies that associate with level of fractional exhaled nitric oxide (FeNO), one of that factors is race therefore we can't use level from another studies with different race for use as reference and there is no study about level of fractional exhaled nitric oxide in Thai population.

It is therefore desirable to examine level of fractional exhaled nitric oxide (FeNO) in healthy subjects among Thai population and will be the main objective of this research.

Study Design
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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Measurements of Exhaled Nitric Oxide in Healthy Subjects in Thailand
Study Start Date : October 2010
Actual Primary Completion Date : June 2015
Actual Study Completion Date : August 2015

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. fractional exhaled nitric oxide level [ Time Frame: 10 minutes (average time ), on the day of enrollment ]

Eligibility Criteria
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Ages Eligible for Study:   6 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
community sample
Criteria

Inclusion Criteria:

  • healthy subjects in community

Exclusion Criteria:

  • smoker or past history of smoking
  • asthma, allergic rhinitis, chronic respiratory disease or other chronic illness
  • history of wheezing within 12 months before enrollment
  • history of upper or lower respiratory tract infection within 6 weeks before enrollment
  • drink ethanol within 48 hours before enrollment
  • drink caffeine within day before enrollment
  • during pregnancy
  • chronic use of any drugs
  • participate other project within 30 days
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02554617


Locations
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Thailand
Siriraj Hospital
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Professor Nualanong Visitsunthorn, MD Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
More Information
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Responsible Party: Nualanong Visitsunthorn, Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT02554617    
Other Study ID Numbers: 555/2552(EC2)
First Posted: September 18, 2015    Key Record Dates
Last Update Posted: May 3, 2016
Last Verified: May 2016
Keywords provided by Nualanong Visitsunthorn, Mahidol University:
healthy people
fractional exhaled nitric oxide (FeNo)
factors