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

Eosinophilic Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05398133
• Other study ID #: MB/M/15(31)
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: June 2022

Study information

• Verified date: May 2022
• Source: Medical University of Warsaw
• Contact: Katarzyna Gorska, MD PhD
• Phone: 22 599 27 53
• Email: drkpgorska[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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)

• Exclusion of parasitic diseases

• Informed consent to participate in the study

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Asthma
• COPD Asthma
• Eosinophilic Asthma
• Pulmonary Eosinophilia

Locations

Country	Name	City	State
Poland	Medical University of Warsaw, Banacha Hospital	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	expression of surface markers	expression of CD125, CD62L, CD66b, CD193, CD11b, CD14	performed up to 3 months after blood and sputum collection