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CompletedNCT03423693Updated Jun 18, 2024

Small Airway Obstruction in Asthma, COPD, ACOS

An observational study in Asthma, COPD and Asthma-COPD Overlap Syndrome, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-06-18.

Sponsored by Mahidol University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
230
Ages
18 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Asthma
  • COPD
  • Asthma-COPD Overlap Syndrome

Keywords

  • Small airway obstruction
  • Asthma
  • COPD
  • ACOS
03

In context

Asthma

4,012 studies on the registry are indexed under Asthma; 514 are open to participants now.

This study's enrollment of 230 is above the median of 150 across 993 observational studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Mahidol University is the lead sponsor of 744 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants recruited from Asthma Clinics and OPD in Siriraj Hospital

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Physician-diagnosed asthma, ACO, and COPD
  • Their spirometric, IOS, lung volume, demographic data and sputum samples are available

Exclusion criteria

Exclusion Criteria:

  • Concomitant diseases requiring immunosuppressive therapy
  • Being on treatments with NSAIDs, macrolides, statins
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
230 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Asthma with SAO+

    Asthmatic patients with RV/TLC \> or = 40

    Other: No any intervention

  • Asthma with SAO-

    Asthmatic patients with RV/TLC \< 40

    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)

    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)

    Other: No any intervention

Interventions

  • OtherNo any intervention

    No any intervention is applied to any groups in this study

06

What researchers measure

Primary outcomes

  1. Lipoxin A4, ,

    Lipoxin A4 is measured in sputum supernatants by ELISA

    Time frame: 1 day (single time point)

Secondary outcomes

  1. IL-33

    IL-33 is measured in sputum supernatants by ELISA

    Time frame: 1 day (single time point)

  2. Thymic stromal lymphopoietin (TSLP)

    TSLP is measured in sputum supernatants by ELISA

    Time frame: 1 day (single time point)

07

Study locations

1 site
  • Siriraj Hospital
    Bangkok Noi, Bangkok 10700, Thailand
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2018 to primary completion in Jul 2020, 30 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 30, 2018
First posted
Feb 6, 2018
StartActual
Jan 10, 2018
Primary completionActual
Jul 31, 2020
CompletionActual
Dec 31, 2020
Last update
Jun 18, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03423693
Lead sponsor
Mahidol University
Responsible party
Kittipong Maneechotesuwan (Professor, Mahidol University) — Principal investigator
First posted
Feb 6, 2018
Start date
Jan 10, 2018
Primary completion
Jul 31, 2020
Completion
Dec 31, 2020
Last update
Jun 18, 2024

Study contacts

Kittipong Maneechotesuwan, MD, PhD
principal investigator · Siriraj Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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