COPDBIOBPCONCT04963023
Biomarkers of Chronic Obstructive Pulmonary Disease
An observational study of COPD and Asthma-COPD Overlap Syndrome, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Asthma-COPD Overlap Syndrome, Asthma
- What is being tested?
- Physical examinations and blood test
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2021to 1 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: chronic obstructive pulmonary disease (COPD) patients, followed in Amiens-University Hospital
Who may be able to join
- BPCO patients
- ACOS patients
- asthmatic patient without BPCO
Who cannot join
- infection
- exacerbation
- immunosuppressive treatment
- immunosuppressive disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Specific Biomarker Identification of Different Subgroups of Chronic Obstructive Pulmonary Disease
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.
- Conditions
- COPD, Asthma-COPD Overlap Syndrome, Asthma
- Being tested
- Physical examinations, blood test
- Keywords
- COPD, Asthma-COPD Overlap Syndrome, Asthma
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical examinationsOther
BPCO physical examinations
blood testDiagnostic test
blood test in order to study immunologic markers
| Study group | Role | What they receive |
|---|---|---|
| frequent exacerbation patients | Not described Receives: Other: Physical examinations; Diagnostic Test: blood test | |
| non frequent exacerbation patients | Not described Receives: Other: Physical examinations; Diagnostic Test: blood test | |
| Asthma-and-COPD overlap syndrome | Not described Receives: Other: Physical examinations; Diagnostic Test: blood test | |
| Asthmatic patients (without COPD) | Not described Receives: Other: Physical examinations; Diagnostic Test: blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
identification specific blood immunologic marker for COPD
COPD biomarkers are blood immunologic markers
Measured: one hour
Secondary outcomes (3)
Complete blood count (CBC) Variation between COPD and asthmatic patients
Measured: one hour
c-reactive protein concentration variation between COPD and asthmatic patients
Measured: one hour
Plasma protein electrophoresis profile Variation between COPD and asthmatic patients
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start15 Jun 2021
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963023
- Sponsor's protocol ID
- PI2021_843_0051
- Acronym
- BIOBPCO
- Status last verified
- Aug 2023
- First submitted
- 17 Jun 2021
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specific Biomarker Identification of Different Subgroups of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04963023
- Acronym / sponsor ID
- BIOBPCO / PI2021_843_0051
- Conditions
- COPD, Asthma-COPD Overlap Syndrome, Asthma
- Keywords
- COPD, Asthma-COPD Overlap Syndrome, Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 15 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| frequent exacerbation patients | – | Other: Physical examinations, Diagnostic Test: blood test |
| non frequent exacerbation patients | – | Other: Physical examinations, Diagnostic Test: blood test |
| Asthma-and-COPD overlap syndrome | – | Other: Physical examinations, Diagnostic Test: blood test |
| Asthmatic patients (without COPD) | – | Other: Physical examinations, Diagnostic Test: blood test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- chronic obstructive pulmonary disease (COPD) patients, followed in Amiens-University Hospital
Key inclusion criteria (3 listed)
- BPCO patients
- ACOS patients
- asthmatic patient without BPCO
Key exclusion criteria (4 listed)
- infection
- exacerbation
- immunosuppressive treatment
- immunosuppressive disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical examinationsBPCO physical examinations | Other | Asthma-and-COPD overlap syndrome, Asthmatic patients (without COPD), frequent exacerbation patients, non frequent exacerbation patients |
| blood testblood test in order to study immunologic markers | Diagnostic test | Asthma-and-COPD overlap syndrome, Asthmatic patients (without COPD), frequent exacerbation patients, non frequent exacerbation patients |
Primary outcome
identification specific blood immunologic marker for COPD
Time frame: one hour
COPD biomarkers are blood immunologic markers
3 secondary outcomes
Complete blood count (CBC) Variation between COPD and asthmatic patients
Time frame: one hour
c-reactive protein concentration variation between COPD and asthmatic patients
Time frame: one hour
Plasma protein electrophoresis profile Variation between COPD and asthmatic patients
Time frame: one hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Asthma-COPD Overlap Syndrome, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
identification specific blood immunologic marker for COPD (time frame: one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.