Evaluation of Immunological, Microbiological and Metabolomic Profiles in COPD

NCT ID: NCT06826560

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 92 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2024-12-31

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

Smokers without COPD

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

No interventions assigned to this group

Never-smokers

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

No interventions assigned to this group

Eligibility Criteria

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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Warsaw

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University of Warsaw, Banacha Hospital

Warsaw, , Poland

Countries

Poland

Other Identifiers

NCN-NZ5/00694-1

Identifier Type: -

Identifier Source: org_study_id