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Completed

NCT Number: NCT03853642

Blood Eosinophil Measurements in Patients With Chronic Obstructive Pulmonary Disease

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universiatir Ziekenhuis Brussel

Brussels, 1090, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Blood sampling

Other

Blood sampling, Spirometry, Fraction exhaled Nitric Oxide

Other names: Spirometry and Fraction exhaled Nitric Oxide

Primary outcomes

  1. Within-day within-subject level changes of blood eosinophils

    Time frame: 12 hours

    Describe the within-day within-subject levels of blood eosinophils and determine the within-day within-subject variability of blood eosinophils

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Collaborators

  • Vrije Universiteit Brussel

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 25, 2019
Registry last updated
Mar 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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