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Exhaled Markers in COPD during viral and/or bacterial induced Exacerbations

Exhaled Markers in COPD during viral and/or bacterial induced Exacerbations - MACE study

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON42952
Enrollment
396
Registered
2016-06-17
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

COPD

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: • History of other pulmonary disease • Systemic steroid or antibiotic therapy for > 24 hours

Design outcomes

Primary

MeasureTime frame
Part I Breathprints obtained by SpiroNose of patients during an exacerbation of COPD with or without bacterial infection. Bacterial infection will be defined as colony-forming units >107/mL sputum or >105/mL in S. pneumonia [36]. Part II Changes in breathprints obtained by SpiroNose of patients during exacerbation and recovery with or without viral, bacterial, viral and bacterial, or absence of infection. A virus was deemed present when either the sputum or naso-pharyngeal swap tested positive by PCR [31].

Secondary

MeasureTime frame
Secondary study parameters (part I and II): • Specific molecular components (VOCs), which are, associated with the different origins of exacerbation of COPD patients as determined by gas- chromatography and mass-spectrometry (GC-MS). We will determine: retention time, abundance and the mass-to-charge ratio. • Individual cellular and molecular biomarkers in sputum and blood. We will determine CRP, a complete blood count including differentiation, inflammatory markers, cytokines and chemokines.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)