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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03853642
Other study ID # UniversitairZB 18-409
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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