NCT04963023

Brief Summary

There are few studies about immunological explorations in COPD. Because of the complications of lung biopsies, analyses are generally made on blood samples instead of lung tissue. No study tried to classify COPD vs Asthma vs ACOS. The investigators wondered if there were differences in biomarkers between these groups. The investigators decided to open a pilot-study among COPD patients followed in Amiens-University Hospital. Each patient will be examined and a blood-test will be performed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

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

Study Start

First participant enrolled

June 15, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 15, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

August 23, 2023

Status Verified

August 1, 2023

Enrollment Period

2 years

First QC Date

June 17, 2021

Last Update Submit

August 22, 2023

Conditions

COPDAsthma-COPD Overlap SyndromeAsthma

Keywords

COPDAsthma-COPD Overlap SyndromeAsthma

Outcome Measures

Primary Outcomes (1)

  • identification specific blood immunologic marker for COPD

    COPD biomarkers are blood immunologic markers

    one hour

Secondary Outcomes (3)

  • Complete blood count (CBC) Variation between COPD and asthmatic patients

    one hour

  • c-reactive protein concentration variation between COPD and asthmatic patients

    one hour

  • Plasma protein electrophoresis profile Variation between COPD and asthmatic patients

    one hour

Study Arms (4)

frequent exacerbation patients

Other: Physical examinationsDiagnostic Test: blood test

non frequent exacerbation patients

Other: Physical examinationsDiagnostic Test: blood test

Asthma-and-COPD overlap syndrome

Other: Physical examinationsDiagnostic Test: blood test

Asthmatic patients (without COPD)

Other: Physical examinationsDiagnostic Test: blood test

Interventions

Physical examinationsOTHER

BPCO physical examinations

Asthma-and-COPD overlap syndromeAsthmatic patients (without COPD)frequent exacerbation patientsnon frequent exacerbation patients
blood testDIAGNOSTIC_TEST

blood test in order to study immunologic markers

Asthma-and-COPD overlap syndromeAsthmatic patients (without COPD)frequent exacerbation patientsnon frequent exacerbation patients

Eligibility Criteria

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

chronic obstructive pulmonary disease (COPD) patients, followed in Amiens-University Hospital

You may qualify if:

  • BPCO patients
  • ACOS patients
  • asthmatic patient without BPCO

You may not qualify if:

  • infection
  • exacerbation
  • immunosuppressive treatment
  • immunosuppressive disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveAsthma-Chronic Obstructive Pulmonary Disease Overlap SyndromeAsthma

Interventions

Restraint, PhysicalHematologic Tests

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchial DiseasesRespiratory HypersensitivityHypersensitivityImmune System DiseasesHypersensitivity, Immediate

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2021

First Posted

July 15, 2021

Study Start

June 15, 2021

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

August 23, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)