N/A
N=35
Molecular Breath Print of COPD Patients With Exacerbations Despite Triple Inhalational Therapy
COPD Exacerbation
Bottom Line
View on ClinicalTrials.gov: NCT04638920 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Change in Exhaled Breath Metabolites — 3298 breath metabolites
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- No intervention (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Malcolm Kohler
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Exhaled Breath Metabolites |
3298 | — |
| SECONDARY Symptoms |
— | — |
| SECONDARY Inflammation |
— | — |
| SECONDARY Causative Agents |
— | — |
| SECONDARY Treatment |
— | — |
Summary
Determination of specific molecular breath patterns by secondary electrospray ionization mass spectrometry (SESIHRMS) during and 8 weeks after a COPD exacerbation. Furthermore, breath patterns will be assessed for correlation and association with clinical outcomes and treatment.
Eligibility Criteria
Inclusion Criteria
- Informed consent
- age >= 18 years
- staged according to GOLD recommendations
- GOLD stage 2-4, GOLD ABE classification
- hospitalization due to COPD exacerbation
- subjects adherent to triple inhalational therapy (beta-2-sympathomimetics, anticholinergics, steroids)
- suitable for follow-up assessment
- 11% or Glc >20mmol/l)
- acute or chronic pulmonary disease other than COPD
- renal failure or renal replacement therapy (GFR < 15 mL/min)
Data sourced from ClinicalTrials.gov (NCT04638920). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.