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Drivers of Eosinophilic COPD Exacerbations

Drivers of Eosinophilic COPD Exacerbations - DICE

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON54085
Enrollment
100
Registered
2021-03-11
Start date
2021-07-21
Completion date
Unknown
Last updated
2024-04-09

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

Conditions

chronic obstructive pulmonary disease emphysema and chronic bronchitis.

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - COPD patient admitted to the hospital for an acute exacerbation - A physician diagnosed COPD according to the GOLD 2017 guidelines - Age >40 years - Smoker or ex-smoker, >10 pack years of smoking

Exclusion criteria

Exclusion criteria: - Current asthma or prior physician diagnosis of asthma without a symptom-free interval of at least 10 years before the age of 40 - Use of systemic corticosteroids >-4 days prior to hospital admission - Necessity (upon hospitalization) for non-invasive ventilation or ICU admission - Pneumonia at hospital admission, defined by the clincal presentation and the presence of a lobar consolidation on radiographical imaging - Any other clinically relevant lung disease deemed to interfere with the concept of the study design - Pregnancy and lactation.

Design outcomes

Primary

MeasureTime frame
Gene expression differences in sputum and nasal epithelium between eosinophilic COPD exacerbations and other subtypes.

Secondary

MeasureTime frame
1. Microbiome composition and immunophenotyping profiles of the different subtypes, i) eosinophilic, ii) viral, iii) bacterial, iv) pauci-inflammatory. 2. Course and duration of symptoms, measured by changes in peak flow and CAT scores. 3. RNA sequencing in nasal epithelium and sputum, and immunophenotyping in blood. 4. Differences in the sputum and nasal epithelial microbiome between COPD exacerbation subtypes, both during stable state and exacerbations. 5. Per subtype: course and duration of symptoms (CAT questionnaire), and lung function recovery after exacerbation, duration of hospital admission, risk of 2nd exacerbation during the follow-up.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)