COPD AsthmaNCT05398133
Phenotype Assessment of Blood and Airway Eosinophils in Patients With COPD and Asthma
An observational study of COPD Asthma and Eosinophilic Asthma, run by Medical University of Warsaw at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD Asthma, Eosinophilic Asthma
- How many people
- 36 participants
- Where
- 1 sitePoland
- Study dates
- 1 Sep 2020to Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: COPD and asthma patients fulfilling the inclusion and exclusion criteria will be recruited from the outpatient clinic.
Who may be able to join
- 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)
Who cannot join
- Informed consent to participate in the study
- 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
Show all 9Show fewer
- Use of immunosuppressive or immunomodulating drugs in the 3 months preceding the study
- Contraindications to sputum induction
- No consent to participate in the study
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Warsaw, Banacha Hospital
Warsaw, 02-097
Katarzyna Gorska, MD PhD, 22 599 27 53, drkpgorska@gmail.com
About this study
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
- Medical subject headings
- Pulmonary Eosinophilia, Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COPD patients | Not described | |
| asthma patients | Not described | |
| control subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
expression of surface markers
expression of CD125, CD62L, CD66b, CD193, CD11b, CD14
Measured: performed up to 3 months after blood and sputum collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start1 Sep 2020
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD AsthmaStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398133
- Sponsor's protocol ID
- MB/M/15(31)
- Status last verified
- May 2022
- First submitted
- 19 May 2022
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotype Assessment of Blood and Airway Eosinophils in Patients With COPD and Asthma
- ClinicalTrials.gov ID
- NCT05398133
- Acronym / sponsor ID
- MB/M/15(31)
- Conditions
- COPD Asthma, Eosinophilic Asthma
- Keywords
- eosinophil, COPD, asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COPD patients | – | – |
| asthma patients | – | – |
| control subjects | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- COPD and asthma patients fulfilling the inclusion and exclusion criteria will be recruited from the outpatient clinic.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (9 listed)
- Informed consent to participate in the study
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
expression of surface markers
Time frame: performed up to 3 months after blood and sputum collection
expression of CD125, CD62L, CD66b, CD193, CD11b, CD14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD Asthma and Eosinophilic Asthma, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katarzyna Gorska, MD PhD (22 599 27 53, drkpgorska@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
expression of surface markers (time frame: performed up to 3 months after blood and sputum collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.