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Status unknownNCT05398133Updated May 31, 2022

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

An observational study in COPD Asthma and Eosinophilic Asthma, sponsored by Medical University of Warsaw. Status unknown at 1 site in Poland. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-31.

Sponsored by Medical University of Warsaw · Observational

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
36
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • COPD Asthma
  • Eosinophilic Asthma

Keywords

  • eosinophil
  • COPD
  • asthma
03

In context

Pulmonary Eosinophilia

103 studies on the registry are indexed under Pulmonary Eosinophilia; 21 are open to participants now.

This study's planned enrollment of 36 is below the median of 78 across 46 observational studies indexed under Pulmonary Eosinophilia.

Browse Pulmonary Eosinophilia studies →

Lead sponsor

Medical University of Warsaw is the lead sponsor of 325 studies on the registry; 87 are open to participants now.

Browse Medical University of Warsaw studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Eligibility criteria

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
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
36 participants (estimated)
Patient registry
No

Groups and cohorts

  • COPD patients
  • asthma patients
  • control subjects
06

What researchers measure

Primary outcomes

  1. expression of surface markers

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

    Time frame: performed up to 3 months after blood and sputum collection

07

Study locations

1 of 1 sites recruiting
  • Medical University of Warsaw, Banacha Hospital
    Warsaw, 02-097, Poland
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2020 (actual). Primary completion is estimated for Jun 2022, 21 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 19, 2022
First posted
May 31, 2022
StartActual
Sep 1, 2020
Primary completionEst.
Jun 2022
CompletionEst.
Jun 2022
Last update
May 31, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05398133
Lead sponsor
Medical University of Warsaw
Responsible party
Sponsor
First posted
May 31, 2022
Start date
Sep 1, 2020
Primary completion
Jun 2022 (estimated)
Completion
Jun 2022 (estimated)
Last update
May 31, 2022

Study contacts

Katarzyna Gorska, MD PhD
Contact
drkpgorska@gmail.com
22 599 27 53

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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