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

Copd Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04123028
• Other study ID #: 60-319-14-3
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: October 2019
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Copd

Intervention

Other:
• observatory
observation for 1 year period

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Prince of Songkla university	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute worsening of respiratory symptoms	acute severe worsening of respiratory symptoms	1 year
Secondary	Physiological outcomes	Forced expiratory volume in one second	1 year
Secondary	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