The Role of Congenital Mucosal Immune System in the Airways of Patients With Chronic Obstructive Pulmonary Disease

NCT ID: NCT04061122

Last Updated: 2019-08-19

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

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-04

Study Completion Date

2020-06-30

Brief Summary

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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

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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

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COPD Exacerbation Smoking, Tobacco

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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EX + / ECTS +

Patients suffering COPD exacerbation in last 7 days; active tobacco smokers

airway epithelial smear test

Intervention Type DIAGNOSTIC_TEST

all patients will be subjected to all scheduled procedures: airways epithelial smear test, measurement of VOCs in exhaled air and airways slide sample culture

EX - / ECTS +

Patients without COPD exacerbation in last 6 months; active tobacco smokers

airway epithelial smear test

Intervention Type DIAGNOSTIC_TEST

all patients will be subjected to all scheduled procedures: airways epithelial smear test, measurement of VOCs in exhaled air and airways slide sample culture

EX + / ECTS -

Patients suffering COPD exacerbation in last 7 days; quited tobacco smoking at least 12 months earlier

airway epithelial smear test

Intervention Type DIAGNOSTIC_TEST

all patients will be subjected to all scheduled procedures: airways epithelial smear test, measurement of VOCs in exhaled air and airways slide sample culture

EX - / ECTS -

Patients without COPD exacerbation in last 6 months; quited tobacco smoking at least 12 months earlier

airway epithelial smear test

Intervention Type DIAGNOSTIC_TEST

all patients will be subjected to all scheduled procedures: airways epithelial smear test, measurement of VOCs in exhaled air and airways slide sample culture

Interventions

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airway epithelial smear test

all patients will be subjected to all scheduled procedures: airways epithelial smear test, measurement of VOCs in exhaled air and airways slide sample culture

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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measurement of VOCs culture

Eligibility Criteria

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Exclusion Criteria

* Neoplasm
* Diabetes
* Astma
* acute airway infection in last 2 weeks
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Lodz

OTHER

Sponsor Role lead

Responsible Party

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Pawel Majak

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Internal Medicine, Asthma and Allergy, Barlicki University Hospital, Medical University of Lodz, Lodz, Poland

Lodz, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Paweł Majak

Role: CONTACT

600621878

Facility Contacts

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Pawel Majak, MD, PhD

Role: primary

Other Identifiers

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RNN/206/16IKE

Identifier Type: -

Identifier Source: org_study_id

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