AsthmaNCT04454385
The Correlations of FeNO, Blood Eosinophils and Lung Function in Well-controlled Asthma
An observational study of Asthma, run by Hat Yai Medical Education Center at 1 site in Thailand.
Trial summary
In Asthma, the levels of exhaled FeNO is correlated to sputum eosinophils particularly in the patient with poor controlled asthma or severe asthma. Moreover, the blood eosinophils had been studied that are also correlated to sputum eosinophils in similar patients group. Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Asthma
- How many people
- 84 participants
- Where
- 1 siteThailand
- Study dates
- 1 Aug 2020to 31 Oct 2020
- 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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with well controlled asthma treating with step 3 base on GINA by only low dose ICS/LABA based on ACT (> = 23) and ACQ-7 (<0.75) for at least 12 weeks
Who may be able to join
- Patients with diagnosis of asthma (according to the guidelines)
- Age >15 years
- Patients with treating with step 3 base on GINA by only low dose ICS/LABA without oral bronchodilator with being in well controlled asthma based on ACT (> = 23) and ACQ-7 (<0.75) for at least 12 weeks
- Ability to provide informed consent and do spirometry following ATS guideline
Who cannot join
- Pulmonary infection or exacerbation within the last 12 weeks before enrolment
- Patients with preceding taken systemic steroid 12 week before enrolment
- Additional pulmonary diseases (pneumonia, lung cancer, tuberculosis, interstitial lung disease)
- A history of smoking >= 10 pack-year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Correlations of FeNO, Blood Eosinophils and Lung Function in Well-controlled Asthma Based on Asthma Controlled Questionnaires
In Asthma, the levels of exhaled FeNO is correlated to sputum eosinophils particularly in the patient with poor controlled asthma or severe asthma. Moreover, the blood eosinophils had been studied that are also correlated to sputum eosinophils in similar patients group. According to well controlled asthma, althoug hin clinical practice guidelines recommend that the stepping down therapy should be considered to those patients due to the risks or costs of daily treatment, there is previous study has been shown that the airway hyperresponsiveness and sputum eosinophilia are predictors of loss of control during dose reduction. And, these tests are not readily available in primary care. However, there is limit number of clinical study to study the correlation of biologic markers among the patients with well controlled level before the stepping down management.
Read the detailed description
This is a single prospective trial. Enrollment will continue until 50 patients with well controlled asthma have been entered into this trial and have completed blood tests and spirometry. In this trial, the following parameters are to be evaluated:
Blood eosinophils (absolute and relative) FeNO Pulmonary lung function test: FEV1, FVC, PF, MMEF 25-75%, % reversibility
- Conditions
- Asthma
- Being tested
- Patients with well controlled asthma
- Keywords
- FeNO, Blood eosinophil, Pulmonary function test, Well controlled asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with well controlled asthmaDiagnostic test
Patients with well controlled asthma
The following parameters are to be evaluated:
Blood eosinophils FeNO Findings on lung function test
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of eosinophilic inflammation by correlating blood eosinophil count, FeNO measurement and lung function test
Correlation of FeNO, blood eosinophils, lung function test in patients with well controlled asthma before stepping down medication
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start1 Aug 2020
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hat Yai Medical Education Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Narongwit Nakwan, Hat Yai Medical Education Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454385
- Sponsor's protocol ID
- 56/2563
- Status last verified
- Jun 2020
- First submitted
- 28 Jun 2020
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlations of FeNO, Blood Eosinophils and Lung Function in Well-controlled Asthma Based on Asthma Controlled Questionnaires
- ClinicalTrials.gov ID
- NCT04454385
- Acronym / sponsor ID
- 56/2563
- Conditions
- Asthma
- Keywords
- FeNO, Blood eosinophil, Pulmonary function test, Well controlled asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Hat Yai Medical Education CenterUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 1 Jul 2020 (actual)
- 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.
In Asthma, the levels of exhaled FeNO is correlated to sputum eosinophils particularly in the patient with poor controlled asthma or severe asthma. Moreover, the blood eosinophils had been studied that are also correlated to sputum eosinophils in similar patients group. According to well controlled asthma, althoug hin clinical practice guidelines recommend that the stepping down therapy should be considered to those patients due to the risks or costs of daily treatment, there is previous study has been shown that the airway hyperresponsiveness and sputum eosinophilia are predictors of loss of control during dose reduction. And, these tests are not readily available in primary care. However, there is limit number of clinical study to study the correlation of biologic markers among the patients with well controlled level before the stepping down management.
Detailed description
This is a single prospective trial. Enrollment will continue until 50 patients with well controlled asthma have been entered into this trial and have completed blood tests and spirometry. In this trial, the following parameters are to be evaluated:
Blood eosinophils (absolute and relative) FeNO Pulmonary lung function test: FEV1, FVC, PF, MMEF 25-75%, % reversibility
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with well controlled asthma treating with step 3 base on GINA by only low dose ICS/LABA based on ACT (> = 23) and ACQ-7 (<0.75) for at least 12 weeks
Key inclusion criteria (4 listed)
- Patients with diagnosis of asthma (according to the guidelines)
- Age >15 years
- Patients with treating with step 3 base on GINA by only low dose ICS/LABA without oral bronchodilator with being in well controlled asthma based on ACT (> = 23) and ACQ-7 (<0.75) for at least 12 weeks
- Ability to provide informed consent and do spirometry following ATS guideline
Key exclusion criteria (4 listed)
- Pulmonary infection or exacerbation within the last 12 weeks before enrolment
- Patients with preceding taken systemic steroid 12 week before enrolment
- Additional pulmonary diseases (pneumonia, lung cancer, tuberculosis, interstitial lung disease)
- A history of smoking >= 10 pack-year
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 |
|---|---|---|
| Patients with well controlled asthmaPatients with well controlled asthma The following parameters are to be evaluated: Blood eosinophils FeNO Findings on lung function test | Diagnostic test | – |
Primary outcome
Assessment of eosinophilic inflammation by correlating blood eosinophil count, FeNO measurement and lung function test
Time frame: 3 months
Correlation of FeNO, blood eosinophils, lung function test in patients with well controlled asthma before stepping down medication
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 15 Jan 2021.
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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.
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 Asthma, run by Hat Yai Medical Education Center 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 4 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 15 Jan 2021. 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?
Assessment of eosinophilic inflammation by correlating blood eosinophil count, FeNO measurement and lung function test (time frame: 3 months). 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 15 Jan 2021.