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

Completed

• Conditions: Copd
• Interventions: Other: observatory

• Registration Number: NCT04123028
• Lead Sponsor: Prince of Songkla University

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.

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 Timeline

• Study Start: 2017-12-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-10
• Study First Submitted: 2019-10-08
• Study First Submitted QC: 2019-10-09
• Last Update Submitted: 2019-10-09
• Study First Posted: 2019-10-10
• Last Update Posted: 2019-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
eosinophilic COPD patient	observatory	COPD patient with blood eosinophil equal or \> 300 cells/µL
non-eosinophilic COPD patient	observatory	COPD patient with blood eosinophil \< 300 cells/µL

Primary Outcome Measures

Name	Time	Method
Acute worsening of respiratory symptoms	1 year	acute severe worsening of respiratory symptoms

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Medicine, Prince of Songkla university; 🇹🇭 Songkhla, Thailand