COPDV-FEONCT04494308
Evaluation of Eosinophil Phenotype in COPD Patients
An observational study of COPD and COPD Exacerbation, run by IRCCS San Raffaele Roma at 1 site in Italy.
Trial summary
This is a pilot non pharmacological observational study. Aim of the study is to analyze the immunophenotype of circulating eosinophils in chronic obstructive pulmonary disease (COPD) patients, and to correlate results with clinical status of patients (stable versus exacerbated patients, response to therapy). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, COPD Exacerbation
- What is being tested?
- biomarker identification
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 19 Mar 2019to Jul 2025
- 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: 30 COPD patients, of which 15 will be COPD patients admitted to the Pulmonary Rehabilitation Unit of IRCCS San Raffaele Pisana hospital for an exacerbation occurred within the past 10 days (exacerbated cohort); the other 15 will be stable patients, (no exacerbations in the past 3 months- stable cohort), affering to the hospital as outpatients for routine controls
Who may be able to join
- COPD
- percentage of eosinophils >0%
- episode of exacerbation in the previous 10 days (for exacerbated cohort)
- no exacerbation in the previous 3 months (for stable cohort)
Who cannot join
- percentage of eosinophils =0%
- history of allergic diseases
- patients that are currently enrolled in other clinical trials involving new drugs or treatments
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Raffaele Pisana
Roma, RM, 00166
Vittorio Cardaci, MD, +39 0666052336, vittorio.cardaci@sanraffaele.it
laura Vitiello, PhD, +39 06 52253440, laura.vitiello@sanraffaele.it
About this study
Official title: Pilot Study for Evaluation of Eosinophils Phenotype and Activation Status in COPD Patients
This is a pilot non pharmacological observational study. Aim of the study is to analyze the immunophenotype of circulating eosinophils in chronic obstructive pulmonary disease (COPD) patients, and to correlate results with clinical status of patients (stable versus exacerbated patients, response to therapy). In about 30% of COPD patients there is an increase in the number of circulating eosinophils, which associates with an increased risk for exacerbation. However, no data is available on the role of eosinophils in this disease, on their activation status and their response to chemotactic factors. By multicolor flow cytometry the investigators will analyze membrane molecules and intracellular cytokines associated to chemotaxis, degranulation and inflammation. The study will enroll 30 patients (15 stable and 15 with exacerbation). Results will be analyzed taking into account clinical status,disease progression and response to treatment.
Read the detailed description
In about 30% of COPD patients there is an increased number of circulating eosinophils. On their membrane, eosinophils express several molecules, also related to their physiology, namely major histocompatibility complex (MHC) class II, needed for antigen presentation; CCR3, receptor for a variety of chemokines, including eotaxin (CCL11), eotaxin-3 (CCL26), monocyte chemotactict protein (MCP)-3 (CCL7), MCP-4 (CCL13), and RANTES (CCL5); cluster of differentiation (CD)125, which binds IL-5 and stimulates eosinophils proliferation; CD63, a marker that is upregulated after eosinophils degranulation; and CD294 (CRTH2) which is the prostaglandin D2 receptor, and is associated to allergy and inflammation . The hypothesis for the present trial is that different clinical phenotypes of COPD patients could be associated to different activation statuses of eosinophils, that can be evaluated analyzing by flow cytometry the membrane expression of the above mentioned molecules. In particular, the investigators hypothesize that membrane molecules may be modulated in different stages of the diseases, and may change after medical and rehabilitative therapies.
The investigators will analyze phenotype of eosinophils from blood samples of patients with COPD, admitted to the hospital after an episode of exacerbation, or for routine controls. In this way, the association between a particular pattern of molecules expressed on eosinophils membrane and the severity of COPD will be defined. Moreover, for hospitalized patients, eosinophils phenotype also on discharge day will be analyzed. In this way the effect of therapies on eosinophils activation will be assessed. Clinical status of patients will be assessed by standard tests such as St George Respiratory Questionnaire (SGRQ), BODE index, COPD Assessment Test (CAT), Six min. Walking Test (6'WT), Pulmonary Function Tests (PFT).
Eosinophils phenotype and in vitro cytokines production will be analyzed by multicolor flow cytometry. To minimize the effect of manipulation, staining of membrane molecules will be performed on whole blood samples, followed by lysis of erythrocytes. The following molecules will be analyzed: CD45, CD16, CD15, CD63, CCR3, CD125, CD294, Siglec-8. After in vitro stimulation with lipopolysaccharide (LPS) or CCL11, the production of interleukine (IL)-4, TGFbeta and IL-2 will be analyzed.
- Conditions
- COPD, COPD Exacerbation
- Being tested
- biomarker identification
- Keywords
- eosinophils, immunophenotype, inflammation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biomarker identificationOther
flow cytometric analysis of eosinophils membrane molecules
| Study group | Role | What they receive |
|---|---|---|
| exacerbated | COPD patients admitted to the hospital for an exacerbation occurred within the past 10 days. Receives: Other: biomarker identification | |
| stable | COPD stable patients with no exacerbations in the past 3 months Receives: Other: biomarker identification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of eosinophils phenotype with clinical status in COPD patients
We expect to identify different patterns of expression of molecules on eosinophils membrane that are associated with different clinical phenotypes of COPD patients. We will also associate eosinophils phenotype to the response to medical and rehabilitation therapy. The definition of these patterns will provide a diagnostic tool to rapidly identify patients that will benefit from a specific therapy
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start19 Mar 2019
- Primary completion31 Jul 2024 (estimated)
- Study completionJul 2025 (estimated)
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.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Vitiello, PhD, Principal investigator, IRCCS San Raffaele Pisana, Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494308
- Sponsor's protocol ID
- RP 06/18
- Acronym
- V-FEO
- Status last verified
- Jun 2023
- First submitted
- 28 Jul 2020
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for Evaluation of Eosinophils Phenotype and Activation Status in COPD Patients
- ClinicalTrials.gov ID
- NCT04494308
- Acronym / sponsor ID
- V-FEO / RP 06/18
- Conditions
- COPD, COPD Exacerbation
- Keywords
- eosinophils, immunophenotype, inflammation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Study start
- 19 Mar 2019 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 31 Jul 2020 (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.
This is a pilot non pharmacological observational study. Aim of the study is to analyze the immunophenotype of circulating eosinophils in chronic obstructive pulmonary disease (COPD) patients, and to correlate results with clinical status of patients (stable versus exacerbated patients, response to therapy). In about 30% of COPD patients there is an increase in the number of circulating eosinophils, which associates with an increased risk for exacerbation. However, no data is available on the role of eosinophils in this disease, on their activation status and their response to chemotactic factors. By multicolor flow cytometry the investigators will analyze membrane molecules and intracellular cytokines associated to chemotaxis, degranulation and inflammation. The study will enroll 30 patients (15 stable and 15 with exacerbation). Results will be analyzed taking into account clinical status,disease progression and response to treatment.
Detailed description
In about 30% of COPD patients there is an increased number of circulating eosinophils. On their membrane, eosinophils express several molecules, also related to their physiology, namely major histocompatibility complex (MHC) class II, needed for antigen presentation; CCR3, receptor for a variety of chemokines, including eotaxin (CCL11), eotaxin-3 (CCL26), monocyte chemotactict protein (MCP)-3 (CCL7), MCP-4 (CCL13), and RANTES (CCL5); cluster of differentiation (CD)125, which binds IL-5 and stimulates eosinophils proliferation; CD63, a marker that is upregulated after eosinophils degranulation; and CD294 (CRTH2) which is the prostaglandin D2 receptor, and is associated to allergy and inflammation . The hypothesis for the present trial is that different clinical phenotypes of COPD patients could be associated to different activation statuses of eosinophils, that can be evaluated analyzing by flow cytometry the membrane expression of the above mentioned molecules. In particular, the investigators hypothesize that membrane molecules may be modulated in different stages of the diseases, and may change after medical and rehabilitative therapies.
The investigators will analyze phenotype of eosinophils from blood samples of patients with COPD, admitted to the hospital after an episode of exacerbation, or for routine controls. In this way, the association between a particular pattern of molecules expressed on eosinophils membrane and the severity of COPD will be defined. Moreover, for hospitalized patients, eosinophils phenotype also on discharge day will be analyzed. In this way the effect of therapies on eosinophils activation will be assessed. Clinical status of patients will be assessed by standard tests such as St George Respiratory Questionnaire (SGRQ), BODE index, COPD Assessment Test (CAT), Six min. Walking Test (6'WT), Pulmonary Function Tests (PFT).
Eosinophils phenotype and in vitro cytokines production will be analyzed by multicolor flow cytometry. To minimize the effect of manipulation, staining of membrane molecules will be performed on whole blood samples, followed by lysis of erythrocytes. The following molecules will be analyzed: CD45, CD16, CD15, CD63, CCR3, CD125, CD294, Siglec-8. After in vitro stimulation with lipopolysaccharide (LPS) or CCL11, the production of interleukine (IL)-4, TGFbeta and IL-2 will be analyzed.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exacerbated | – | Other: biomarker identificationCOPD patients admitted to the hospital for an exacerbation occurred within the past 10 days. |
| stable | – | Other: biomarker identificationCOPD stable patients with no exacerbations in the past 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 COPD patients, of which 15 will be COPD patients admitted to the Pulmonary Rehabilitation Unit of IRCCS San Raffaele Pisana hospital for an exacerbation occurred within the past 10 days (exacerbated cohort); the other 15 will be stable patients, (no exacerbations in the past 3 months- stable cohort), affering to the hospital as outpatients for routine controls
Key inclusion criteria (4 listed)
- COPD
- percentage of eosinophils >0%
- episode of exacerbation in the previous 10 days (for exacerbated cohort)
- no exacerbation in the previous 3 months (for stable cohort)
Key exclusion criteria (3 listed)
- percentage of eosinophils =0%
- history of allergic diseases
- patients that are currently enrolled in other clinical trials involving new drugs or treatments
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 |
|---|---|---|
| biomarker identificationflow cytometric analysis of eosinophils membrane molecules | Other | exacerbated, stable |
Primary outcome
Association of eosinophils phenotype with clinical status in COPD patients
Time frame: one year
We expect to identify different patterns of expression of molecules on eosinophils membrane that are associated with different clinical phenotypes of COPD patients. We will also associate eosinophils phenotype to the response to medical and rehabilitation therapy. The definition of these patterns will provide a diagnostic tool to rapidly identify patients that will benefit from a specific therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- 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.
Laura Vitiello, PhD principal investigator
IRCCS San Raffaele Pisana, Roma
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 COPD Exacerbation, run by IRCCS San Raffaele Roma at 1 site in Italy.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Apr 2024. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vittorio Cardaci, MD (+39 0666052336, vittorio.cardaci@sanraffaele.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of eosinophils phenotype with clinical status in COPD patients (time frame: one year). 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 10 Apr 2024.