Evaluation of Eosinophil Phenotype in COPD Patients

NCT04494308 | Unknown DMC

• 1 other identifier: RP 06/18
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

COPD; COPD Exacerbation

Keywords

eosinophils; immunophenotype; inflammation

Outcome Measures

Primary Outcomes (1)

• 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

  one year

Study Arms (2)

exacerbated

COPD patients admitted to the hospital for an exacerbation occurred within the past 10 days.

Other: biomarker identification

stable

COPD stable patients with no exacerbations in the past 3 months

Other: biomarker identification

Interventions

biomarker identification OTHER

flow cytometric analysis of eosinophils membrane molecules

exacerbated; stable

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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)

You may not qualify if:

• percentage of eosinophils =0%
• history of allergic diseases
• patients that are currently enrolled in other clinical trials involving new drugs or treatments

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead

Study Sites (1)

IRCCS San Raffaele Pisana

Roma, RM, 00166, Italy

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Inflammation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Laura Vitiello, PhD

  IRCCS San Raffaele Pisana, Roma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vittorio Cardaci, MD

CONTACT

+39 0666052336; vittorio.cardaci@sanraffaele.it

Laura Vitiello, PhD

CONTACT

+39 0652253440; laura.vitiello@sanraffaele.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: July 31, 2020
• Study Start: March 19, 2019
• Primary Completion: July 31, 2024
• Study Completion: July 1, 2025
• Last Updated: April 10, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)