Blood Eosinophil Measurements in Patients With Chronic Obstructive Pulmonary Disease

NCT ID: NCT03853642

Last Updated: 2020-03-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2020-03-28

Brief 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.

Detailed 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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Single-arm trial

Patient receiving blood sampling, spirometry and Feno

Blood sampling

Intervention Type: OTHER

Blood sampling, Spirometry, Fraction exhaled Nitric Oxide

Interventions

Blood sampling

Blood sampling, Spirometry, Fraction exhaled Nitric Oxide

Intervention Type: OTHER

Other Intervention Names

Spirometry and Fraction exhaled Nitric Oxide

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vrije Universiteit Brussel

OTHER

Sponsor Role: collaborator

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ines Van Rossem, MD

Role: PRINCIPAL_INVESTIGATOR

Vrije Universiteit Brussel

Locations

Universiatir Ziekenhuis Brussel

Brussels, , Belgium

Countries

Belgium

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

UniversitairZB 18-409

Identifier Type: -

Identifier Source: org_study_id