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

NCT ID: NCT05398133

Last Updated: 2022-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2022-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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COPD Asthma Eosinophilic Asthma

Keywords

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eosinophil COPD asthma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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COPD patients

No interventions assigned to this group

asthma patients

No interventions assigned to this group

control subjects

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medical University of Warsaw, Banacha Hospital

Warsaw, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Katarzyna Gorska, MD PhD

Role: CONTACT

Phone: 22 599 27 53

Email: [email protected]

Facility Contacts

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Katarzyna Gorska, MD PhD

Role: primary

Other Identifiers

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MB/M/15(31)

Identifier Type: -

Identifier Source: org_study_id