Bronchial AsthmaNCT02561351
Correlation Between Fractional Exhaled Nitric Oxide (FeNO) Levels and Asthma Exacerbation
An observational study of Bronchial Asthma, run by Mahidol University.
Trial summary
The purpose of this study is to determine mean or median of fractional exhaled nitric oxide (FeNO) in Thai atopic asthmatic children that divided into subgroups due to asthma exacerbation according to the global initiative for asthma guideline. Read more about this study
- Who is it for?
- Ages 7 to 20 years
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- FeNO measurement
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Sep 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 7 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: atopic asthmatic patients in Department of Pediatrics, Siriraj hospital (tertiary care)
Who may be able to join
- clinical diagnosis of atopic bronchial asthma follow up in clinic of allergy and clinical immunology, Siriraj hospital
Who cannot join
- smoker or past history of smoking
- chronic disease eg. HIV infection, pulmonary hypertension, systemic lupus erythematosus, liver cirrhosis, gastroesophageal reflux, COPD, bronchiectasis
- drink ethanol within 48 hours before enrollment
- history of upper or lower respiratory tract infection within 6 weeks before enrollment drink caffeine within day before enrollment during pregnancy history of systemic steroid use within 8 weeks before enrollment
About this study
The purpose of this study is to determine mean or median of fractional exhaled nitric oxide (FeNO) in Thai atopic asthmatic children that divided into subgroups due to asthma exacerbation according to the global initiative for asthma guideline.
Read the detailed description
From many previous studies, fractional exhaled nitric oxide (FeNO) has many benefits such as non-invasive, easily to perform, less time consume, has direct association with severity of inflammation of bronchial trees and sputum eosinophils, has benefit for diagnosis and monitoring the treatment in asthmatic patients.
In Thailand, this field of study is less extend, especially in children population. The investigators hypothesized that patients with asthma exacerbation may have high level of fractional exhaled nitric oxide (FeNO) than non exacerbation group.
It is therefore desirable to examine the association between fractional exhaled nitric oxide (FeNO) and asthma exacerbation among atopic asthmatic Thai children and will be the main objective of this research.
- Conditions
- Bronchial Asthma
- Being tested
- FeNO measurement
- Keywords
- bronchial asthma, fractional exhaled nitric oxide (FeNO), asthma exacerbation
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FeNO measurementOther
FeNO was performed repeatedly every 3 months in every cases. exacerbations were recorded each visit
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of asthma exacerbation in the studied cases with different FeNO levels
Occurrence of asthma exacerbation in 1 year after the study
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2015 (estimated)
- Study startSep 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial AsthmaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nualanong Visitsunthorn, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561351
- Sponsor's protocol ID
- Si237/2013
- Status last verified
- May 2016
- First submitted
- 16 Sep 2015
- 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
- Correlation Between Fractional Exhaled Nitric Oxide (FeNO) Levels and Asthma Exacerbation
- ClinicalTrials.gov ID
- NCT02561351
- Acronym / sponsor ID
- Si237/2013
- Conditions
- Bronchial Asthma
- Keywords
- bronchial asthma, fractional exhaled nitric oxide (FeNO), asthma exacerbation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 28 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 mean or median of fractional exhaled nitric oxide (FeNO) in Thai atopic asthmatic children that divided into subgroups due to asthma exacerbation according to the global initiative for asthma guideline.
Detailed description
From many previous studies, fractional exhaled nitric oxide (FeNO) has many benefits such as non-invasive, easily to perform, less time consume, has direct association with severity of inflammation of bronchial trees and sputum eosinophils, has benefit for diagnosis and monitoring the treatment in asthmatic patients.
In Thailand, this field of study is less extend, especially in children population. The investigators hypothesized that patients with asthma exacerbation may have high level of fractional exhaled nitric oxide (FeNO) than non exacerbation group.
It is therefore desirable to examine the association between fractional exhaled nitric oxide (FeNO) and asthma exacerbation among atopic asthmatic Thai children and will be the main objective of this research.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- atopic asthmatic patients in Department of Pediatrics, Siriraj hospital (tertiary care)
Key inclusion criteria (1 listed)
- clinical diagnosis of atopic bronchial asthma follow up in clinic of allergy and clinical immunology, Siriraj hospital
Key exclusion criteria (4 listed)
- smoker or past history of smoking
- chronic disease eg. HIV infection, pulmonary hypertension, systemic lupus erythematosus, liver cirrhosis, gastroesophageal reflux, COPD, bronchiectasis
- drink ethanol within 48 hours before enrollment
- history of upper or lower respiratory tract infection within 6 weeks before enrollment drink caffeine within day before enrollment during pregnancy history of systemic steroid use within 8 weeks 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FeNO measurementFeNO was performed repeatedly every 3 months in every cases. exacerbations were recorded each visit | Other | – |
Primary outcome
Occurrence of asthma exacerbation in the studied cases with different FeNO levels
Time frame: 1 year
Occurrence of asthma exacerbation in 1 year after the study
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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchial Asthma, run by Mahidol University.
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 4 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.
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?
Occurrence of asthma exacerbation in the studied cases with different FeNO levels (time frame: 1 year). 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.