The Role of Congenital Mucosal Immune System in the Airways of Patients With Chronic Obstructive Pulmonary Disease
August 16, 2019 updated by: Pawel Majak, Medical University of Lodz
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Lodz, Poland, 90-153
- Recruiting
- Department of Internal Medicine, Asthma and Allergy, Barlicki University Hospital, Medical University of Lodz, Lodz, Poland
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Contact:
- Pawel Majak, MD, PhD
- Email: pawel.majak@umed.lodz.pl
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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
Description
Exclusion Criteria:
- Neoplasm
- Diabetes
- Astma
- acute airway infection in last 2 weeks
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
EX + / ECTS +
Patients suffering COPD exacerbation in last 7 days; active tobacco smokers
|
all patients will be subjected to all scheduled procedures: airways epithelial smear test, measurement of VOCs in exhaled air and airways slide sample culture
Other Names:
|
|
EX - / ECTS +
Patients without COPD exacerbation in last 6 months; active tobacco smokers
|
all patients will be subjected to all scheduled procedures: airways epithelial smear test, measurement of VOCs in exhaled air and airways slide sample culture
Other Names:
|
|
EX + / ECTS -
Patients suffering COPD exacerbation in last 7 days; quited tobacco smoking at least 12 months earlier
|
all patients will be subjected to all scheduled procedures: airways epithelial smear test, measurement of VOCs in exhaled air and airways slide sample culture
Other Names:
|
|
EX - / ECTS -
Patients without COPD exacerbation in last 6 months; quited tobacco smoking at least 12 months earlier
|
all patients will be subjected to all scheduled procedures: airways epithelial smear test, measurement of VOCs in exhaled air and airways slide sample culture
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 4, 2018
Primary Completion (Anticipated)
January 30, 2020
Study Completion (Anticipated)
June 30, 2020
Study Registration Dates
First Submitted
August 12, 2019
First Submitted That Met QC Criteria
August 16, 2019
First Posted (Actual)
August 19, 2019
Study Record Updates
Last Update Posted (Actual)
August 19, 2019
Last Update Submitted That Met QC Criteria
August 16, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- RNN/206/16IKE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.