Normal Non-fluencyFeNO_norNCT02554617
Measurements of Exhaled Nitric Oxide in Healthy Subjects in Thailand
An observational study of Normal Non-fluency, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine fractional exhaled nitric oxide (FeNO) level in healthy subjects among Thai populations. Read more about this study
- Who is it for?
- Ages 6 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Non-fluency
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2010to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: community sample
Who may be able to join
- healthy subjects in community
Who cannot join
- 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
Show all 9Show fewer
- during pregnancy
- chronic use of any drugs
- participate other project within 30 days
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine fractional exhaled nitric oxide (FeNO) level in healthy subjects among Thai populations.
Read the 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.
- Conditions
- Normal Non-fluency
- Keywords
- healthy people, fractional exhaled nitric oxide (FeNo), factors
What is being measured
The primary outcome is the main question the study is designed to answer.
fractional exhaled nitric oxide level
Measured: 10 minutes (average time ), on the day of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study startOct 2010
- Primary completionJun 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Non-fluencyStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nualanong Visitsunthorn, Mahidol University
- Investigators
- Professor Nualanong Visitsunthorn, MD, Principal investigator, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554617
- Sponsor's protocol ID
- 555/2552(EC2)
- Acronym
- FeNO_nor
- Status last verified
- May 2016
- First submitted
- 18 Jul 2010
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurements of Exhaled Nitric Oxide in Healthy Subjects in Thailand
- ClinicalTrials.gov ID
- NCT02554617
- Acronym / sponsor ID
- FeNO_nor / 555/2552(EC2)
- Conditions
- Normal Non-fluency
- Keywords
- healthy people, fractional exhaled nitric oxide (FeNo), factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 18 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine fractional exhaled nitric oxide (FeNO) level in healthy subjects among Thai populations.
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
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- community sample
Key inclusion criteria (1 listed)
- healthy subjects in community
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
fractional exhaled nitric oxide level
Time frame: 10 minutes (average time ), on the day of enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor Nualanong Visitsunthorn, MD principal investigator
Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal Non-fluency, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fractional exhaled nitric oxide level (time frame: 10 minutes (average time ), on the day of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2016.