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 Contact

  • Name: Paweł Majak
  • Phone Number: 600621878
  • Email: pmajak@o2.pl

Study Locations

  • Poland
      • Lodz, Poland, 90-153
        • Recruiting
        • Department of Internal Medicine, Asthma and Allergy, Barlicki University Hospital, Medical University of Lodz, Lodz, Poland
        • Contact:

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
Diagnostic test: 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
Other Names:
  • measurement of VOCs
  • culture
EX - / ECTS +
Patients without COPD exacerbation in last 6 months; active tobacco smokers
Diagnostic test: 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
Other Names:
  • measurement of VOCs
  • culture
EX + / ECTS -
Patients suffering COPD exacerbation in last 7 days; quited tobacco smoking at least 12 months earlier
Diagnostic test: 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
Other Names:
  • measurement of VOCs
  • culture
EX - / ECTS -
Patients without COPD exacerbation in last 6 months; quited tobacco smoking at least 12 months earlier
Diagnostic test: 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
Other Names:
  • measurement of VOCs
  • culture

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

Medical University of Lodz

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.

Clinical Trials on COPD Exacerbation

Clinical Trials on airway epithelial smear test

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe