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Identifying mucosal defence mechanisms against viral infections in patients with COPD and consequences for the development of exacerbations

Identifying mucosal defence mechanisms against viral infections in patients with COPD and consequences for the development of exacerbations - Mucosal Immunity Against Viral Infections in COPD (MIAVIC)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57047
Enrollment
200
Registered
2024-03-28
Start date
2025-09-18
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD (Chronic Obstructive Pulmonary Disease), Chonic bronchitis, Emphysema Chronic Obstructive Pulmonary Disease

Interventions

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Asymptomatic smoking age- and sex-matched controls (40-75 years, n=50) Patients with usual COPD (postbronchodilator FEV1/FVC ratio <0,7 40-75 years, n=50)  without exacerbations Patients with usual COPD (postbronchodilator FEV1/FVC ratio <0,7 40-75 years, n=50)  and frequent exacerbations (=1 moderate exacerbations and/or >=1 severe exacerbation  with ER-visit/hospitalisation in the past year)Patients with COPD related to alpha-1 antitrypsin deficiency (AATD-COPD) (postbronchodilator FEV1/FVC ratio <0,7 40-75 years, n=50), genotype Pi*ZZ, without exacerbations. 

Exclusion criteria

Exclusion criteria: • Incompetence to provide informed consent prior or during study • History of severe nose bleedings • Diagnosed with chronic rhinosinusitis, allergic rhinitis and or allergic  asthma • Use of oral corticosteroids or antibiotics in the past 6 weeks (unless a patient is prescribed antibiotics due to a persistent bacterial colonization in the lung) • Symptoms of a respiratory tract infection or common cold in the past 2 weeks • Immunocompromised individuals (with primary immune deficiency or secondary  immune deficiency) and individuals using methotrexate. • Bronchiectasis, lung cancer or other forms of cancer. • Life expectancy <28 days in the opinion of study physician • Vaccination in the last month

Design outcomes

Primary

MeasureTime frame
To compare Type I and III interferons (IFNs) and IFN-stimulated genes (ISGs) IFN-beta gene expression in nasal secretions, as a proxy for nasal anti-viral defence readiness, in COPD patients with and without frequent exacerbations under steady state conditions.

Secondary

MeasureTime frame
1. In depth (gene) profiling of innate immune cells in nose and blood of asymptomatic smokers, and in COPD patients with or without frequent exacerbations. 2. Analysis of secreted immune mediators (e.g. cytokines, antimicrobial defence molecules, immunoglobulins and metabolites) in nasal lining fluid and blood of each group. 3. Determine the interferon score in each group through collective analysis of the expression of interferon-stimulated genes and IFN protein levels, and other relevant downstream signalling molecules. 4. Assess the responsiveness of nasal epithelium to viral infections in ex vivo cultured nasal cells (through expanded organoid cultures). 5. Associate nasal and systemic factors (e.g. cytokines, immunoglobulins and metabolites) with innate immune cells.

Countries

Netherlands

Contacts

Public ContactW Hoepel

Leids Universitair Medisch Centrum

miavic@lumc.nl+31 (0) 7152 66162

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 25, 2026