Exhaled Markers in COPD during viral and/or bacterial induced Exacerbations
Withdrawn
- Conditions
- COPD10038716
- Registration Number
- NL-OMON42952
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 396
Inclusion Criteria
a. >= 40 years
b. Smoking history >=10 pack years
c. COPD patients (GOLD stage II-IV) according to GOLD guidelines
d. Meeting the criteria for an exacerbation at inclusion
Exclusion Criteria
• History of other pulmonary disease
• Systemic steroid or antibiotic therapy for > 24 hours
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Part I<br /><br>Breathprints obtained by SpiroNose of patients during an exacerbation of COPD<br /><br>with or without bacterial infection. Bacterial infection will be defined as<br /><br>colony-forming units >107/mL sputum or >105/mL in S. pneumonia [36].<br /><br><br /><br>Part II<br /><br>Changes in breathprints obtained by SpiroNose of patients during exacerbation<br /><br>and recovery with or without viral, bacterial, viral and bacterial, or absence<br /><br>of infection. A virus was deemed present when either the sputum or<br /><br>naso-pharyngeal swap tested positive by PCR [31].</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study parameters (part I and II):<br /><br><br /><br>• Specific molecular components (VOCs), which are, associated with the<br /><br>different origins of exacerbation of COPD patients as determined by gas-<br /><br>chromatography and mass-spectrometry (GC-MS). We will determine: retention<br /><br>time, abundance and the mass-to-charge ratio.<br /><br>• Individual cellular and molecular biomarkers in sputum and blood. We will<br /><br>determine CRP, a complete blood count including differentiation, inflammatory<br /><br>markers, cytokines and chemokines.</p><br>