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

Overview

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

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2018

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.

Interventions

  • Other: observatory
    • observation for 1 year period

Arms, Groups and Cohorts

  • eosinophilic COPD patient
    • COPD patient with blood eosinophil equal or > 300 cells/µL
  • non-eosinophilic COPD patient
    • COPD patient with blood eosinophil < 300 cells/µL

Clinical Trial Outcome Measures

Primary Measures

  • Acute worsening of respiratory symptoms
    • Time Frame: 1 year
    • acute severe worsening of respiratory symptoms

Secondary Measures

  • Physiological outcomes
    • Time Frame: 1 year
    • Forced expiratory volume in one second
  • health related quality of life
    • Time Frame: 1 year
    • CAT score

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Prince of Songkla University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Siwasak Juthong, Faculty of Medicine – Prince of Songkla University
  • Overall Official(s)
    • Kanung Saejiam, MS, Study Director, Prince of Songkla University

References

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. Review. Erratum in: Lancet Respir Med. 2017 Aug;5(8):e28.

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