AsthmaNCT03423693
Small Airway Obstruction in Asthma, COPD, ACOS
An observational study of Asthma and COPD, run by Mahidol University at 1 site in Thailand.
Trial summary
This study was designed as retrospective chart review to test our hypothesis whether there are the differences in inflammatory and anti-inflammatory mediators between asthmatic and ACOS patients with small airway obstruction, and COPD Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma, COPD, Asthma-COPD Overlap Syndrome
- What is being tested?
- No any intervention
- How many people
- 230 participants
- Where
- 1 siteThailand
- Study dates
- 10 Jan 2018to 31 Dec 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants recruited from Asthma Clinics and OPD in Siriraj Hospital
Who may be able to join
- Physician-diagnosed asthma, ACO, and COPD
- Their spirometric, IOS, lung volume, demographic data and sputum samples are available
Who cannot join
- Concomitant diseases requiring immunosuppressive therapy
- Being on treatments with NSAIDs, macrolides, statins
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study on Sputum Anti-inflammatory Mediators in Patients With Asthma or Asthma and COPD Overlap (ACOS) Syndrome, and COPD
This study was designed as retrospective chart review to test our hypothesis whether there are the differences in inflammatory and anti-inflammatory mediators between asthmatic and ACOS patients with small airway obstruction, and COPD
Read the detailed description
The data including spirometry, lung volume, impulse oscillometry, sputum data, demographic characters within 6 months are collected for later analysis. Sputum supernatants and cytospins are used to determine inflammatory and anti-inflammatory responses in those patients.
- Conditions
- Asthma, COPD, Asthma-COPD Overlap Syndrome
- Being tested
- No any intervention
- Keywords
- Small airway obstruction, Asthma, COPD, ACOS
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive, Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No any interventionOther
No any intervention is applied to any groups in this study
| Study group | Role | What they receive |
|---|---|---|
| Asthma with SAO+ | Asthmatic patients with RV/TLC > or = 40 Receives: Other: No any intervention | |
| Asthma with SAO- | Asthmatic patients with RV/TLC < 40 Receives: Other: No any intervention | |
| ACO | Asthmatic patients with smoking > or = 10 pack years who have persistent airway obstruction (post-BD FEV1/FVC < 0.7) or COPD patients who have bronchodilator (BD) reversibility (absolute increase in FEV1 > or = 200 ml and FEV1% > or =12% after BD) Receives: Other: No any intervention | |
| COPD | Patients with history of smoking > or = 10 pack year with post-BD FEV1/FVC < 0.7 and negative BD reversibility (absolute increase in FEV1 < 200 ml and FEV1% <12% after BD) Receives: Other: No any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipoxin A4, ,
Lipoxin A4 is measured in sputum supernatants by ELISA
Measured: 1 day (single time point)
Secondary outcomes (2)
IL-33
IL-33 is measured in sputum supernatants by ELISA
Measured: 1 day (single time point)
Thymic stromal lymphopoietin (TSLP)
TSLP is measured in sputum supernatants by ELISA
Measured: 1 day (single time point)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start10 Jan 2018
- Primary completion31 Jul 2020
- Study completion31 Dec 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
- Retrospective
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kittipong Maneechotesuwan, Mahidol University
- Investigators
- Kittipong Maneechotesuwan, MD, PhD, Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423693
- Sponsor's protocol ID
- Si527/2015
- Status last verified
- Jun 2024
- First submitted
- 30 Jan 2018
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study on Sputum Anti-inflammatory Mediators in Patients With Asthma or Asthma and COPD Overlap (ACOS) Syndrome, and COPD
- ClinicalTrials.gov ID
- NCT03423693
- Acronym / sponsor ID
- Si527/2015
- Conditions
- Asthma, COPD, Asthma-COPD Overlap Syndrome
- Keywords
- Small airway obstruction, Asthma, COPD, ACOS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 6 Feb 2018 (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.
This study was designed as retrospective chart review to test our hypothesis whether there are the differences in inflammatory and anti-inflammatory mediators between asthmatic and ACOS patients with small airway obstruction, and COPD
Detailed description
The data including spirometry, lung volume, impulse oscillometry, sputum data, demographic characters within 6 months are collected for later analysis. Sputum supernatants and cytospins are used to determine inflammatory and anti-inflammatory responses in those patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Asthma with SAO+ | – | Other: No any interventionAsthmatic patients with RV/TLC > or = 40 |
| Asthma with SAO- | – | Other: No any interventionAsthmatic patients with RV/TLC < 40 |
| ACO | – | Other: No any interventionAsthmatic patients with smoking > or = 10 pack years who have persistent airway obstruction (post-BD FEV1/FVC < 0.7) or COPD patients who have bronchodilator (BD) reversibility (absolute increase in FEV1 > or = 200 ml and FEV1% > or =12% after BD) |
| COPD | – | Other: No any interventionPatients with history of smoking > or = 10 pack year with post-BD FEV1/FVC < 0.7 and negative BD reversibility (absolute increase in FEV1 < 200 ml and FEV1% <12% after BD) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants recruited from Asthma Clinics and OPD in Siriraj Hospital
Key inclusion criteria (2 listed)
- Physician-diagnosed asthma, ACO, and COPD
- Their spirometric, IOS, lung volume, demographic data and sputum samples are available
Key exclusion criteria (2 listed)
- Concomitant diseases requiring immunosuppressive therapy
- Being on treatments with NSAIDs, macrolides, statins
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 |
|---|---|---|
| No any interventionNo any intervention is applied to any groups in this study | Other | ACO, Asthma with SAO+, Asthma with SAO-, COPD |
Primary outcome
Lipoxin A4, ,
Time frame: 1 day (single time point)
Lipoxin A4 is measured in sputum supernatants by ELISA
2 secondary outcomes
IL-33
Time frame: 1 day (single time point)
Thymic stromal lymphopoietin (TSLP)
Time frame: 1 day (single time point)
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 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Kittipong Maneechotesuwan, MD, PhD principal investigator
Siriraj Hospital
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 and COPD, 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 2 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 Jun 2024. 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?
Lipoxin A4, , (time frame: 1 day (single time point)). 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 Jun 2024.