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

• Conditions: Smoking, Tobacco; COPD Exacerbation
• Interventions: Diagnostic Test: airway epithelial smear test

• Registration Number: NCT04061122
• Lead Sponsor: Medical University of Lodz

Brief 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.

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 Timeline

• Study Start: 2018-07-04
• Status Verified: 2019-08
• Study First Submitted: 2019-08-12
• Study First Submitted QC: 2019-08-16
• Last Update Submitted: 2019-08-16
• Study First Posted: 2019-08-19
• Last Update Posted: 2019-08-19
• Primary Completion: 2020-01-30
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

• Neoplasm
• Diabetes
• Astma
• acute airway infection in last 2 weeks

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EX - / ECTS -	airway epithelial smear test	Patients without COPD exacerbation in last 6 months; quited tobacco smoking at least 12 months earlier
EX + / ECTS -	airway epithelial smear test	Patients suffering COPD exacerbation in last 7 days; quited tobacco smoking at least 12 months earlier
EX - / ECTS +	airway epithelial smear test	Patients without COPD exacerbation in last 6 months; active tobacco smokers
EX + / ECTS +	airway epithelial smear test	Patients suffering COPD exacerbation in last 7 days; active tobacco smokers

Primary Outcome Measures

Name	Time	Method
percentage of nasal ILCs (Innate lymphoid cells) after COPD exacerbation	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)

Trial Locations

Locations (1)

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