CopdNCT04123028
The Association Between Blood Eosinophilsp in Thai COPD Patients: A Prospective Study
An observational study of Copd, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
The association of blood eosinophil as a biomarker for eosinophilic Thai COPD patients, such as COPD exacerbation, hospital admission, lung functions and mortlity. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Copd
- What is being tested?
- observatory
- How many people
- 145 participants
- Where
- 1 siteThailand
- Study dates
- 1 Dec 2017to 31 Dec 2018
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Thai COPD patients in out-patient department
Who may be able to join
- diagnosis of COPD by GOLD criteria
Who cannot join
- high blood eosinophil from known causes such as systemic corticosteroid use, malignancy, parasitic infection
- Patients who had previous acute exacerbation within 30-day before study entry
- Patients who had previous systemic corticosteroids used within 30-day before study entry
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine, Prince of Songkla university
Songkhla, 90110
About this study
Official title: The Association Between Blood Eosinophils and Clinical Outcomes of Chronic Obstructive Pulmonary Disease Patients: A Prospective Study
The association of blood eosinophil as a biomarker for eosinophilic Thai COPD patients, such as COPD exacerbation, hospital admission, lung functions and mortlity.
Read the detailed description
The prospective one year study in Thai COPD patients for the clinical outcomes of COPD compare between eosinophilic and non-eosinophilic which determine by blood eosinophil counts equal or more than 300 cells/microliters. The primary outcomes was COPD exacerbation, the secondary outcomes were lung function, dyspnea and quality of life.
- Conditions
- Copd
- Being tested
- observatory
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observatoryOther
Also called clinical outcomes
observation for 1 year period
| Study group | Role | What they receive |
|---|---|---|
| eosinophilic COPD patient | COPD patient with blood eosinophil equal or > 300 cells/µL Receives: Other: observatory | |
| non-eosinophilic COPD patient | COPD patient with blood eosinophil < 300 cells/µL Receives: Other: observatory |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute worsening of respiratory symptoms
acute severe worsening of respiratory symptoms
Measured: 1 year
Secondary outcomes (2)
Physiological outcomes
Forced expiratory volume in one second
Measured: 1 year
health related quality of life
Chronic Obstructive Pulmonary Disease Assessment Test (CAT) scores which the minimum 0 and maximum 40 values, and whether higher scores mean a worse outcome.
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 posted10 Oct 2019
- Study start1 Dec 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CopdStudies 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
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siwasak Juthong, Prince of Songkla University
- Investigators
- Kanung Saejiam, MS, Study director, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123028
- Sponsor's protocol ID
- 60-319-14-3
- Status last verified
- Oct 2019
- First submitted
- 8 Oct 2019
- Last updated
- 11 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bafadhel M, Pavord ID, Russell REK. Eosinophils in COPD: just another biomarker? Lancet Respir Med. 2017 Sep;5(9):747-759. doi: 10.1016/S2213-2600(17)30217-5. Epub 2017 Jun 7.
PubMed 28601554Juthong S, Kaenmuang P. Association between blood eosinophils with exacerbation and patient-reported outcomes in chronic obstructive pulmonary disease patients in an endemic area for parasitic infections: a prospective study. J Thorac Dis. 2020 Sep;12(9):4868-4876. doi: 10.21037/jtd-19-4101.
PubMed 33145060
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Blood Eosinophils and Clinical Outcomes of Chronic Obstructive Pulmonary Disease Patients: A Prospective Study
- ClinicalTrials.gov ID
- NCT04123028
- Acronym / sponsor ID
- 60-319-14-3
- Conditions
- Copd
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 10 Oct 2019 (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.
The association of blood eosinophil as a biomarker for eosinophilic Thai COPD patients, such as COPD exacerbation, hospital admission, lung functions and mortlity.
Detailed description
The prospective one year study in Thai COPD patients for the clinical outcomes of COPD compare between eosinophilic and non-eosinophilic which determine by blood eosinophil counts equal or more than 300 cells/microliters. The primary outcomes was COPD exacerbation, the secondary outcomes were lung function, dyspnea and quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eosinophilic COPD patient | – | Other: observatoryCOPD patient with blood eosinophil equal or > 300 cells/µL |
| non-eosinophilic COPD patient | – | Other: observatoryCOPD patient with blood eosinophil < 300 cells/µL |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Thai COPD patients in out-patient department
Key inclusion criteria (1 listed)
- diagnosis of COPD by GOLD criteria
Key exclusion criteria (3 listed)
- high blood eosinophil from known causes such as systemic corticosteroid use, malignancy, parasitic infection
- Patients who had previous acute exacerbation within 30-day before study entry
- Patients who had previous systemic corticosteroids used within 30-day before study entry
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 |
|---|---|---|
| observatoryAlso: clinical outcomesobservation for 1 year period | Other | eosinophilic COPD patient, non-eosinophilic COPD patient |
Primary outcome
Acute worsening of respiratory symptoms
Time frame: 1 year
acute severe worsening of respiratory symptoms
2 secondary outcomes
Physiological outcomes
Time frame: 1 year
health related quality of life
Time frame: 1 year
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 11 Oct 2019.
- Background: PubMed 28601554Bafadhel M, Pavord ID, Russell REK. Eosinophils in COPD: just another biomarker? Lancet Respir Med. 2017 Sep;5(9):747-759. doi: 10.1016/S2213-2600(17)30217-5. Epub 2017 Jun 7.
- Derived from this study: PubMed 33145060Juthong S, Kaenmuang P. Association between blood eosinophils with exacerbation and patient-reported outcomes in chronic obstructive pulmonary disease patients in an endemic area for parasitic infections: a prospective study. J Thorac Dis. 2020 Sep;12(9):4868-4876. doi: 10.21037/jtd-19-4101.
- Individual participant dataSharing planned: Undecided
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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.
Kanung Saejiam, MS study director
Prince of Songkla 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 Copd, run by Prince of Songkla 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 3 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 11 Oct 2019. 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?
Acute worsening of respiratory symptoms (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04123028, which also lists 2 linked publications.
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 11 Oct 2019.