NCT04123028

Brief Summary

The association of blood eosinophil as a biomarker for eosinophilic Thai COPD patients, such as COPD exacerbation, hospital admission, lung functions and mortlity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
145

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2017

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

December 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
Last Updated

October 11, 2019

Status Verified

October 1, 2019

Enrollment Period

1.1 years

First QC Date

October 8, 2019

Last Update Submit

October 9, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Acute worsening of respiratory symptoms

    acute severe worsening of respiratory symptoms

    1 year

Secondary Outcomes (2)

  • Physiological outcomes

    1 year

  • health related quality of life

    1 year

Study Arms (2)

eosinophilic COPD patient

COPD patient with blood eosinophil equal or \> 300 cells/µL

Other: observatory

non-eosinophilic COPD patient

COPD patient with blood eosinophil \< 300 cells/µL

Other: observatory

Interventions

observation for 1 year period

Also known as: clinical outcomes
eosinophilic COPD patientnon-eosinophilic COPD patient

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Thai COPD patients in out-patient department

You may qualify if:

  • diagnosis of COPD by GOLD criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Prince of Songkla university

Songkhla, 90110, Thailand

Location

Related Publications (2)

  • 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.

    PMID: 28601554BACKGROUND
  • Juthong 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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kanung Saejiam, MS

    Prince of Songkla University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty of Medicine

Study Record Dates

First Submitted

October 8, 2019

First Posted

October 10, 2019

Study Start

December 1, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

October 11, 2019

Record last verified: 2019-10

Locations