NCT03423693

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2018

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 6, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

June 18, 2024

Status Verified

June 1, 2024

Enrollment Period

2.6 years

First QC Date

January 30, 2018

Last Update Submit

June 16, 2024

Conditions

Keywords

Small airway obstructionAsthmaCOPDACOS

Outcome Measures

Primary Outcomes (1)

  • Lipoxin A4, ,

    Lipoxin A4 is measured in sputum supernatants by ELISA

    1 day (single time point)

Secondary Outcomes (2)

  • IL-33

    1 day (single time point)

  • Thymic stromal lymphopoietin (TSLP)

    1 day (single time point)

Study Arms (4)

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

No any intervention is applied to any groups in this study

ACOAsthma with SAO+Asthma with SAO-COPD

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants recruited from Asthma Clinics and OPD in Siriraj Hospital

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital

Bangkok Noi, Bangkok, 10700, Thailand

Location

Biospecimen

Retention: SAMPLES WITH DNA

Sputum cell pellets, sputum supernatants, and sputum cytospins

MeSH Terms

Conditions

AsthmaPulmonary Disease, Chronic ObstructiveAsthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kittipong Maneechotesuwan, MD, PhD

    Siriraj Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 30, 2018

First Posted

February 6, 2018

Study Start

January 10, 2018

Primary Completion

July 31, 2020

Study Completion

December 31, 2020

Last Updated

June 18, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations