Drivers of Eosinophilic COPD Exacerbations
- Conditions
- chronic obstructive pulmonary diseaseemphysema and chronic bronchitis.10006436
- Registration Number
- NL-OMON54085
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
- 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
- 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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Gene expression differences in sputum and nasal epithelium between eosinophilic<br /><br>COPD exacerbations and other subtypes.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Microbiome composition and immunophenotyping profiles of the different<br /><br>subtypes, i) eosinophilic, ii) viral, iii) bacterial, iv) pauci-inflammatory.<br /><br>2. Course and duration of symptoms, measured by changes in peak flow and CAT<br /><br>scores.<br /><br>3. RNA sequencing in nasal epithelium and sputum, and immunophenotyping in<br /><br>blood.<br /><br>4. Differences in the sputum and nasal epithelial microbiome between COPD<br /><br>exacerbation subtypes, both during stable state and exacerbations.<br /><br>5. Per subtype: course and duration of symptoms (CAT questionnaire), and lung<br /><br>function recovery after exacerbation, duration of hospital admission, risk of<br /><br>2nd exacerbation during the follow-up.</p><br>