Small Airway Obstruction in Asthma, COPD, ACOS

June 16, 2024 updated by: Kittipong Maneechotesuwan, Mahidol University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

230

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Bangkok Noi, Bangkok, Thailand, 10700
        • Siriraj Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants recruited from Asthma Clinics and OPD in Siriraj Hospital

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Asthma with SAO+
Asthmatic patients with RV/TLC > or = 40
Other: No any intervention
No any intervention is applied to any groups in this study
Asthma with SAO-
Asthmatic patients with RV/TLC < 40
Other: No any intervention
No any intervention is applied to any groups in this study
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
No any intervention is applied to any groups in this study
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
No any intervention is applied to any groups in this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lipoxin A4, ,
Time Frame: 1 day (single time point)
Lipoxin A4 is measured in sputum supernatants by ELISA
1 day (single time point)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IL-33
Time Frame: 1 day (single time point)
IL-33 is measured in sputum supernatants by ELISA
1 day (single time point)
Thymic stromal lymphopoietin (TSLP)
Time Frame: 1 day (single time point)
TSLP is measured in sputum supernatants by ELISA
1 day (single time point)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Kittipong Maneechotesuwan, MD, PhD, Faculty of Medicine Siriraj Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2018

Primary Completion (Actual)

July 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

January 30, 2018

First Submitted That Met QC Criteria

February 5, 2018

First Posted (Actual)

February 6, 2018

Study Record Updates

Last Update Posted (Actual)

June 18, 2024

Last Update Submitted That Met QC Criteria

June 16, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Si527/2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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