NCT03853642

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 25, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2020

Completed
Last Updated

March 30, 2020

Status Verified

March 1, 2020

Enrollment Period

1.1 years

First QC Date

February 18, 2019

Last Update Submit

March 27, 2020

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Single-arm trial

Patient receiving blood sampling, spirometry and Feno

Other: Blood sampling

Interventions

Blood samplingOTHER

Blood sampling, Spirometry, Fraction exhaled Nitric Oxide

Also known as: Spirometry and Fraction exhaled Nitric Oxide
Single-arm trial

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

COPD patients

You may qualify if:

  • 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

You may not qualify if:

  • Clinical diagnosis of asthma.
  • Pregnancy.
  • A recent exacerbation of COPD (\<4 weeks).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiatir Ziekenhuis Brussel

Brussels, 1090, Belgium

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Ines Van Rossem, MD

    Vrije Universiteit Brussel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2019

First Posted

February 25, 2019

Study Start

March 1, 2019

Primary Completion

March 28, 2020

Study Completion

March 28, 2020

Last Updated

March 30, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)