The Association Between Blood Eosinophilsp in Thai COPD Patients: A Prospective Study

The Association Between Blood Eosinophils and Clinical Outcomes of Chronic Obstructive Pulmonary Disease Patients: A Prospective Study

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

Study Overview

• Status: Completed
• Conditions: Copd
• Intervention / Treatment: Other: observatory

Detailed Description

The prospective one year study in Thai COPD patients for the clinical outcomes of COPD compare between eosinophilic and non-eosinophilic which determine by blood eosinophil counts equal or more than 300 cells/microliters. The primary outcomes was COPD exacerbation, the secondary outcomes were lung function, dyspnea and quality of life.

• Study Type: Observational
• Enrollment (Actual): 145

Contacts and Locations

Study Locations

• Thailand
  • Songkhla, Thailand, 90110
    • Faculty of Medicine, Prince of Songkla University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Thai COPD patients in out-patient department

Description

Inclusion Criteria:

• diagnosis of COPD by GOLD criteria

Exclusion Criteria:

1. high blood eosinophil from known causes such as systemic corticosteroid use, malignancy, parasitic infection
2. Patients who had previous acute exacerbation within 30-day before study entry
3. Patients who had previous systemic corticosteroids used within 30-day before study entry

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
eosinophilic COPD patient; COPD patient with blood eosinophil equal or > 300 cells/µL	Other: observatory; observation for 1 year period; Other Names: clinical outcomes
non-eosinophilic COPD patient; COPD patient with blood eosinophil < 300 cells/µL	Other: observatory; observation for 1 year period; Other Names: clinical outcomes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute worsening of respiratory symptoms	acute severe worsening of respiratory symptoms	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiological outcomes	Forced expiratory volume in one second	1 year
health related quality of life	Chronic Obstructive Pulmonary Disease Assessment Test (CAT) scores which the minimum 0 and maximum 40 values, and whether higher scores mean a worse outcome.	1 year

Collaborators and Investigators

• Sponsor: Prince of Songkla University

Publications and helpful links

General Publications

• 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. Erratum In: Lancet Respir Med. 2017 Aug;5(8):e28.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: October 8, 2019
• First Submitted That Met QC Criteria: October 9, 2019
• First Posted (Actual): October 10, 2019

Study Record Updates

• Last Update Posted (Actual): October 11, 2019
• Last Update Submitted That Met QC Criteria: October 9, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 60-319-14-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No