Evaluation of Immunological, Microbiological and Metabolomic Profiles in COPD

NCT06826560 | Completed

• 1 other identifier: NCN-NZ5/00694-1
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

COPD is a significant health problem worldwide. It affects more than 10% of patients over the age of 40. According to the World Health Organization, it is the third most common cause of death among adults in the world, and the number of patients is continuously growing. Hence, all measures aimed at a better understanding of COPD pathogenesis, the course of the disease, and limitations in treatment efficacy seem critically important. Since 2008 our team has provided a substantial output in understanding the pathophysiology of airway inflammation in obstructive lung diseases. In our studies, we systematically evaluated selected cytokines concentrations in different respiratory samples to determine their mutual relations and to determine the role of cytokines in airway inflammation more precisely. However, there is still a large gap in our understanding of COPD. It is hypothesized that in COPD pathogenesis, additional factors, like genetics, autoimmune processes or deviated microbiota are involved. Each of the mentioned factors leads to a different type of immune response with a different effect on the airways. We believe that using more advanced laboratory methods (i.e. metabolomics and airway microbiome analysis) alongside the well-established ones (i.e. cellular and cytokine composition) will allow for an adequate characterization of inflammation. The study will include 50 COPD subjects and 50 smokers without COPD and 20 control subjects (never smokers) who meet the inclusion and exclusion criteria (Table 1) and give an informed written consent to participate in the study. All study participants will undergo the following procedures: peripheral blood sample collection, chest HRCT imaging (without contrast), lung function assessment (spirometry with a bronchial obstruction reversibility test, bodyplethismography, diffusion lung capacity for carbon monoxide (DLCO), sputum induction with sterile hypertonic saline (NaCl).

Conditions

COPD; Emphysema; Chronic Bronchitis; Smoking

Outcome Measures

Primary Outcomes (1)

• Development of a Risk Calculator for COPD Severity and Phenotyping Using Feature Selection and Enrichment Analysis

  In this study, we will use the Boruta algorithm for feature selection and perform enrichment analysis to identify overrepresented biological pathways. Based on these results, we will develop and validate a calculator that generates a risk score for the disease and predicts the likelihood of severe progression. This calculator will serve as an outcome measure, providing an integrated tool to assess patient status and guide clinical decisions.

  Up to 6 months after sample collection

Secondary Outcomes (2)

• Secondary Outcome Measure 1: Identification of Omics Biomarkers Associated with CT Imaging Changes in COPD

  Up to 6 months after sample collection

• Secondary Outcome Measure 2: Assessment of Host-Environment Interactions via Microbiome Analysis

  Up to 6 months after sample collection

Study Arms (3)

COPD patients

Inclusion criteria age ⩾ 40 years, written informed history of smoking ⩾ 10 pack-years COPD diagnosis (post- bronchodilator FEV1/FVC \< LLN) stable COPD (min. 3 months criteria for the study.

Smokers without COPD

age ⩾ 40 years, written informed history of smoking ⩾ 10 pack-years FEV1/FVC≥LLN

Never-smokers

without \<1 pack-year, COPD no current smoking (min. 1 year prior the study) FEV1/FVC≥LLN

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Each subject visiting the outpatient clinic at our department presenting exertional dyspnoea and/or chronic cough will be screened for eligibility to participate in the study. A control group (never-smokers) will consist of volunteers matched by age and sex to the study group. Inclusion and exclusion criteria are presented in Table 1. Subjects who gave their written informed consent will be divided into three groups (Table 1). The assignment to a specific study group will be based on past medical history, clinical signs and symptoms, and the results of spirometry with a bronchial obstruction reversibility test.

You may qualify if:

• age ⩾ 40 years,
• written informed history of smoking ⩾ 10 pack-years
• COPD diagnosis (post- bronchodilator FEV1/FVC \< LLN)
• stable COPD (min. 3 months)

You may not qualify if:

• history of asthma or current lung disease (exception: solitary nodules), respiratory failure
• use of inhaled or oral steroids in the 3 months prior to the study,
• infection of the respiratory tract or exacerbation in the 3 months prior the study
• uncontrolled comorbidities such as: systemic connective tissue diseases, malignancy, uncontrolled cardiovascular diseases, chronic paranasal sinusitis,
• contraindications to sputum induction

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Medical University of Warsaw, Banacha Hospital

Warsaw, 02-097, Poland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Induced sputum Plasma Stool

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema; Bronchitis, Chronic; Smoking

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Behavior

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: February 14, 2025
• Study Start: March 1, 2022
• Primary Completion: July 30, 2024
• Study Completion: December 31, 2024
• Last Updated: February 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)