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Blood Eosinophil Measurements in Patients With Chronic Obstructive Pulmonary Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03853642
Recruitment Status : Completed
First Posted : February 25, 2019
Last Update Posted : March 30, 2020
Sponsor:
Collaborator:
Vrije Universiteit Brussel
Information provided by (Responsible Party):
Universitair Ziekenhuis Brussel

Study Description
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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.

Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Other: Blood sampling

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.

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Blood Eosinophil Measurements Throughout the Day in Patients With Stable Chronic Obstructive Pulmonary Disease
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : March 28, 2020
Actual Study Completion Date : March 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Groups and Cohorts
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Group/Cohort Intervention/treatment
Single-arm trial
Patient receiving blood sampling, spirometry and Feno
 Other: Blood sampling
Blood sampling, Spirometry, Fraction exhaled Nitric Oxide
Other Name: Spirometry and Fraction exhaled Nitric Oxide


Outcome Measures
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Primary Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
COPD patients
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03853642


Locations
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Belgium
Universiatir Ziekenhuis Brussel
Brussels, Belgium, 1090
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Vrije Universiteit Brussel
Investigators
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Principal Investigator: Ines Van Rossem, MD Vrije Universiteit Brussel
  Study Documents (Full-Text)

Documents provided by Universitair Ziekenhuis Brussel:
Study Protocol  [PDF] November 21, 2018

More Information
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Additional Information:

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Responsible Party: Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT03853642    
Other Study ID Numbers: UniversitairZB 18-409
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
 Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents