BIOBPCO: Biomarkers of Chronic Obstructive Pulmonary Disease

• Sponsor: Centre Hospitalier Universitaire, Amiens (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04963023
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Anticipated Duration (Months): 5.6
• Patients Per Site Per Month: 14.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COPD; Asthma-COPD Overlap Syndrome; Asthma	Other: Physical examinations; Diagnostic Test: blood test

Study Design

• Study Type: Observational
• Anticipated Enrollment: 80 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Specific Biomarker Identification of Different Subgroups of Chronic Obstructive Pulmonary Disease
• Actual Study Start Date: Jun 15, 2021
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
frequent exacerbation patients	Other: Physical examinations; BPCO physical examinations; Diagnostic Test: blood test; blood test in order to study immunologic markers
non frequent exacerbation patients	Other: Physical examinations; BPCO physical examinations; Diagnostic Test: blood test; blood test in order to study immunologic markers
Asthma-and-COPD overlap syndrome	Other: Physical examinations; BPCO physical examinations; Diagnostic Test: blood test; blood test in order to study immunologic markers
Asthmatic patients (without COPD)	Other: Physical examinations; BPCO physical examinations; Diagnostic Test: blood test; blood test in order to study immunologic markers

Outcome Measures

Primary Outcome Measures

1. identification specific blood immunologic marker for COPD [one hour]

   COPD biomarkers are blood immunologic markers

Secondary Outcome Measures

1. Complete blood count (CBC) Variation between COPD and asthmatic patients [one hour]

2. c-reactive protein concentration variation between COPD and asthmatic patients [one hour]

3. Plasma protein electrophoresis profile Variation between COPD and asthmatic patients [one hour]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• BPCO patients

• ACOS patients

• asthmatic patient without BPCO

Exclusion Criteria:

• infection

• exacerbation

• immunosuppressive treatment

• immunosuppressive disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens	Amiens		France	80480

Sponsors and Collaborators

• Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire, Amiens
• ClinicalTrials.gov Identifier: NCT04963023
• Other Study ID Numbers: PI2021_843_0051
• First Posted: Jul 15, 2021
• Last Update Posted: Jul 15, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centre Hospitalier Universitaire, Amiens: COPD; Asthma-COPD Overlap Syndrome; Asthma
• Additional relevant MeSH terms: Asthma; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive; Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome

Study Results

No Results Posted as of Jul 15, 2021