Blood Eosinophil Measurements in Patients With Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Blood Eosinophil Measurements Throughout the Day in Patients With Stable Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03853642
• Other study ID #: UniversitairZB 18-409
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: March 28, 2020

Study information

• Verified date: March 2020
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study will assess the within-day variation of blood eosinophils in patients with Chronic Obstructive Pulmonary disease (COPD) in stable state and determine if there is a correlation between the blood eosinophils and certain clinical parameters.

Description:

COPD is a heterogeneous disease, resulting in different phenotypes with varying clinical and pathophysiological characteristics. One of these pathophysiological features is chronic airway inflammation which can be eosinophilic of nature. Blood eosinophils could be an accessible biomarker for this eosinophilic inflammation.

Eosinophil counts can fluctuate due to their short half-life in blood and due to a diurnal rhythm. More needs to be known about this diurnal rhythm and the different confounding factors and sources of within-subject variability of this biomarker.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 28, 2020
• Est. primary completion date: March 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients willing and able to give informed consent for participation in the study.

• Age 18 years or older.

• Diagnosis of COPD according to GOLD (Global Initiative for Chronic Obstructive Lung Disease): post-bronchodilator Tiffeneau index <0.7), in a stable state of the disease.

• A smoking history of >10 pack-years

Exclusion criteria:

• Clinical diagnosis of asthma.

• Use of systemic corticosteroids (oral, intravenous or infiltration) up to six weeks before inclusion.

• Pregnancy.

• A recent exacerbation of COPD (<4 weeks).

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Blood sampling
Blood sampling, Spirometry, Fraction exhaled Nitric Oxide

Locations

Country	Name	City	State
Belgium	Universiatir Ziekenhuis Brussel	Brussels

Sponsors (2)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel	Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Within-day within-subject level changes of blood eosinophils	Describe the within-day within-subject levels of blood eosinophils and determine the within-day within-subject variability of blood eosinophils	12 hours