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NCT04061122 Clinical Trial

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

COPD Exacerbation Clinical Trial

Official title:
The Role of Congenital Mucosal Immune System in the Airways of Patients With COPD

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04061122
Other study ID # RNN/206/16IKE
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 4, 2018
Est. completion date June 30, 2020

Study information
Verified date August 2019
Source Medical Universtity of Lodz
Contact Pawel Majak
Phone 600621878
Email pmajak@o2.pl
Is FDA regulated No
Health authority
Study type Observational

Clinical 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), airway epithelial cytology and culture.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date June 30, 2020
Est. primary completion date January 30, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Exclusion Criteria:

- Neoplasm

- Diabetes

- Astma

- acute airway infection in last 2 weeks

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Poland Department of Internal Medicine, Asthma and Allergy, Barlicki University Hospital, Medical University of Lodz, Lodz, Poland Lodz

Sponsors (1)
Lead Sponsor Collaborator
Medical Universtity of Lodz

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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) through study completion, an average of 1 year
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