Bronchial AsthmaFeNO_ASNCT01197690
Association Between Fractional Exhaled Nitric Oxide and Asthma Control
An observational study of Bronchial Asthma, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine mean or median of fractional exhaled nitric oxide (FeNO) in Thai atopic asthmatic patients that divided into subgroups due to level of asthma control according to the global initiative for asthma guideline. Read more about this study
- Who is it for?
- Ages 7 to 60 years
- Conditions the study is for
- Bronchial Asthma
- How many people
- 62 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2010to Dec 2010
- 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 60 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
- has 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
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine mean or median of fractional exhaled nitric oxide (FeNO) in Thai atopic asthmatic patients that divided into subgroups due to level of asthma control 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. We hypothesized that in uncontrolled or partly controlled group may have high level of fractional exhaled nitric oxide (FeNO) than controlled group.
It is therefore desirable to examine the association between fractional exhaled nitric oxide (FeNO) and level of asthma control among atopic asthmatic Thai children and will be the main objective of this research.
- Conditions
- Bronchial Asthma
- Keywords
- Bronchial asthma, level of control of asthma, fractional exhaled nitric oxide (FeNO), asthma control test (ACT)
- Medical subject headings
- Asthma
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
Secondary outcomes (1)
scores of asthma control test: ACT
Measured: 5 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 posted9 Sep 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2010
- Study completionDec 2010
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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 62 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
- NCT01197690
- Sponsor's protocol ID
- 602/2552(EC1)
- Acronym
- FeNO_AS
- Status last verified
- Sep 2015
- First submitted
- 18 Jul 2010
- Last updated
- 18 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Fractional Exhaled Nitric Oxide and Asthma Control
- ClinicalTrials.gov ID
- NCT01197690
- Acronym / sponsor ID
- FeNO_AS / 602/2552(EC1)
- Conditions
- Bronchial Asthma
- Keywords
- Bronchial asthma, level of control of asthma, fractional exhaled nitric oxide (FeNO), asthma control test (ACT)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 9 Sep 2010 (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 patients that divided into subgroups due to level of asthma control 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. We hypothesized that in uncontrolled or partly controlled group may have high level of fractional exhaled nitric oxide (FeNO) than controlled group.
It is therefore desirable to examine the association between fractional exhaled nitric oxide (FeNO) and level of asthma control among atopic asthmatic Thai children and will be the main objective of this research.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 7 to 60 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 (2 listed)
- clinical diagnosis of atopic bronchial asthma
- follow up in clinic of allergy and clinical immunology, Siriraj hospital
Key exclusion criteria (7 listed)
- smoker or past history of smoking
- has 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
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
1 secondary outcome
scores of asthma control test: ACT
Time frame: 5 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 18 Sep 2015.
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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.
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 Bronchial Asthma, 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 2 inclusion and 7 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 18 Sep 2015. 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 18 Sep 2015.