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NCT05398133 Clinical Trial

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)
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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