Phenotype Assessment of Blood and Airway Eosinophils in Patients With COPD and Asthma

NCT05398133 | Unknown

• 1 other identifier: MB/M/15(31)
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Around 1/3 of patients with COPD have elevated eosinophil levels. However, the role of eosinophils in COPD has not been yet understood and is probably different in COPD and in asthma. The aim of this study was to assess the expression of selected surface markers on eosinophils and to assess the gene expression in eosinophils in COPD and asthma patients. We are planning to enrol 12 COPD, 12 asthma and 12 control subjects. Patients will undergo routine clinical assessment, spirometry, blood sampling and sputum induction. Eosinophils will be isolated from blood and sputum. Surface markers on eosinophils will be assessed in flow cytometry, gene expression will be assessed by RNAseq.

Conditions

COPD Asthma; Eosinophilic Asthma

Keywords

eosinophil; COPD; asthma

Outcome Measures

Primary Outcomes (1)

• expression of surface markers

  expression of CD125, CD62L, CD66b, CD193, CD11b, CD14

  performed up to 3 months after blood and sputum collection

Study Arms (3)

COPD patients

asthma patients

control subjects

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COPD and asthma patients fulfilling the inclusion and exclusion criteria will be recruited from the outpatient clinic.

You may qualify if:

• Diagnosis of COPD according to GOLD 2019 or asthma according to GINA 2021
• Peripheral blood eosinophil count ≥ 100 / μL
• Age ≥40 years (COPD), ≥18 years (asthma)
• History of cigarette smoking: ≥10 pack-years (for COPD)
• Stable disease period (at least 3 months without exacerbation)
• Informed consent to participate in the study

You may not qualify if:

• COPD and asthma overlap
• Use of systemic corticosteroids in the 3 months prior to the study
• Respiratory infection or exacerbation in the 3 months prior to the study
• Acute and chronic respiratory failure
• Concomitant diagnoses: systemic connective tissue diseases, malignant neoplasms, severe and / or uncontrolled cardiovascular diseases
• Use of immunosuppressive or immunomodulating drugs in the 3 months preceding the study
• Contraindications to sputum induction
• No consent to participate in the study

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Medical University of Warsaw, Banacha Hospital

Warsaw, 02-097, Poland

RECRUITING

MeSH Terms

Conditions

Pulmonary Eosinophilia; Pulmonary Disease, Chronic Obstructive; Asthma

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Katarzyna Gorska, MD PhD

CONTACT

22 599 27 53; drkpgorska@gmail.com

Study Design

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

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 31, 2022
• Study Start: September 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: May 31, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)