COPD ExacerbationNCT04061122
The Role of Congenital Mucosal Immune System in the Airways of Patients With Chronic Obstructive Pulmonary Disease
An observational study of COPD Exacerbation and Smoking, Tobacco, run by Medical University of Lodz at 1 site in Poland.
Trial summary
The purpose of the study is to explore the role of congenital mucosal immune system in the airways of patients with COPD including the impact of ILCs (Innate lymphoid cells) on metabolism of epithelial cells.During the research the following methods will be applied: measurement of Volatile Organic Compounds (VOCS)… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COPD Exacerbation, Smoking, Tobacco
- What is being tested?
- airway epithelial smear test
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 4 Jul 2018to 30 Jun 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: EX (COPD exacerbation) TS (tobacco smoking) Group: EX + / TS + Patients suffering COPD exacerbation in last 7 days; active tobacco smokers Group: EX - / TS + Patients without COPD exacerbation in last 6 months; active tobacco smokers Group: EX + / TS - Patients suffering COPD exacerbation in last 7 days; smoking was stopped a minimum of 12 months before the first visit Group: EX - / TS - Patients without COPD exacerbation in last 6 months; smoking was stopped a minimum of 12 months before the first visit
Who may be able to join
None listed.
Who cannot join
- Neoplasm
- Diabetes
- Astma
- acute airway infection in last 2 weeks
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Internal Medicine, Asthma and Allergy, Barlicki University Hospital, Medical University of Lodz, Lodz, Poland
Lodz, 90-153
Pawel Majak, MD, PhD, pawel.majak@umed.lodz.pl
About this study
Official title: The Role of Congenital Mucosal Immune System in the Airways of Patients With COPD
The purpose of the study is to explore the role of congenital mucosal immune system in the airways of patients with COPD including the impact of ILCs (Innate lymphoid cells) on metabolism of epithelial cells.During the research the following methods will be applied: measurement of Volatile Organic Compounds (VOCS), airway epithelial cytology and culture.
Read the detailed description
ILCs profiles, epithelium metabolism measured by VOCS and microbiome profiling (specific 16S rRNA-16S ribosomal RNA gene-targeted qPCR) will by determined in the airways of patients with COPD after the exacerbation. Microbiome profiling will be based on next generation sequencing (NGS) of the 16S rRNA encoding region.
- Conditions
- COPD Exacerbation, Smoking, Tobacco
- Being tested
- airway epithelial smear test
- Medical subject headings
- Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
airway epithelial smear testDiagnostic test
Also called measurement of VOCs, culture
all patients will be subjected to all scheduled procedures: airways epithelial smear test, measurement of VOCs in exhaled air and airways slide sample culture
| Study group | Role | What they receive |
|---|---|---|
| EX + / ECTS + | Patients suffering COPD exacerbation in last 7 days; active tobacco smokers Receives: Diagnostic Test: airway epithelial smear test | |
| EX - / ECTS + | Patients without COPD exacerbation in last 6 months; active tobacco smokers Receives: Diagnostic Test: airway epithelial smear test | |
| EX + / ECTS - | Patients suffering COPD exacerbation in last 7 days; quited tobacco smoking at least 12 months earlier Receives: Diagnostic Test: airway epithelial smear test | |
| EX - / ECTS - | Patients without COPD exacerbation in last 6 months; quited tobacco smoking at least 12 months earlier Receives: Diagnostic Test: airway epithelial smear test |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of nasal ILCs (Innate lymphoid cells) after COPD exacerbation
The assessment of the nasal mucosa material after COPD exacerbation will include: percentage of ILC1, 2 and 3 cells (immunophenotyping and measurement by flow cytometry)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start4 Jul 2018
- Primary completion30 Jan 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pawel Majak, Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061122
- Sponsor's protocol ID
- RNN/206/16IKE
- Status last verified
- Aug 2019
- First submitted
- 12 Aug 2019
- Last updated
- 19 Aug 2019
- Results posted
- 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 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Congenital Mucosal Immune System in the Airways of Patients With COPD
- ClinicalTrials.gov ID
- NCT04061122
- Acronym / sponsor ID
- RNN/206/16IKE
- Conditions
- COPD Exacerbation, Smoking, Tobacco
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- 4 Jul 2018 (actual)
- Primary completion
- 30 Jan 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 19 Aug 2019 (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.
The purpose of the study is to explore the role of congenital mucosal immune system in the airways of patients with COPD including the impact of ILCs (Innate lymphoid cells) on metabolism of epithelial cells.During the research the following methods will be applied: measurement of Volatile Organic Compounds (VOCS), airway epithelial cytology and culture.
Detailed description
ILCs profiles, epithelium metabolism measured by VOCS and microbiome profiling (specific 16S rRNA-16S ribosomal RNA gene-targeted qPCR) will by determined in the airways of patients with COPD after the exacerbation. Microbiome profiling will be based on next generation sequencing (NGS) of the 16S rRNA encoding region.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| EX + / ECTS + | – | Diagnostic Test: airway epithelial smear testPatients suffering COPD exacerbation in last 7 days; active tobacco smokers |
| EX - / ECTS + | – | Diagnostic Test: airway epithelial smear testPatients without COPD exacerbation in last 6 months; active tobacco smokers |
| EX + / ECTS - | – | Diagnostic Test: airway epithelial smear testPatients suffering COPD exacerbation in last 7 days; quited tobacco smoking at least 12 months earlier |
| EX - / ECTS - | – | Diagnostic Test: airway epithelial smear testPatients without COPD exacerbation in last 6 months; quited tobacco smoking at least 12 months earlier |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- EX (COPD exacerbation) TS (tobacco smoking) Group: EX + / TS + Patients suffering COPD exacerbation in last 7 days; active tobacco smokers Group: EX - / TS + Patients without COPD exacerbation in last 6 months; active tobacco smokers Group: EX + / TS - Patients suffering COPD exacerbation in last 7 days; smoking was stopped a minimum of 12 months before the first visit Group: EX - / TS - Patients without COPD exacerbation in last 6 months; smoking was stopped a minimum of 12 months before the first visit
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Neoplasm
- Diabetes
- Astma
- acute airway infection in last 2 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| airway epithelial smear testAlso: measurement of VOCs, cultureall patients will be subjected to all scheduled procedures: airways epithelial smear test, measurement of VOCs in exhaled air and airways slide sample culture | Diagnostic test | EX + / ECTS +, EX + / ECTS -, EX - / ECTS +, EX - / ECTS - |
Primary outcome
percentage of nasal ILCs (Innate lymphoid cells) after COPD exacerbation
Time frame: through study completion, an average of 1 year
The assessment of the nasal mucosa material after COPD exacerbation will include: percentage of ILC1, 2 and 3 cells (immunophenotyping and measurement by flow cytometry)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
- 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 Exacerbation and Smoking, Tobacco, run by Medical University of Lodz 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 0 inclusion and 4 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 19 Aug 2019. 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 Paweł Majak (600621878, pmajak@o2.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of nasal ILCs (Innate lymphoid cells) after COPD exacerbation (time frame: through study completion, an average of 1 year). 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 19 Aug 2019.