COPD Exacerbation
Conditions
Keywords
Exhaled breath analysis, Mass spectrometry
Brief 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.
Interventions
OTHERNo intervention
No intervention
Sponsors
Deep Breath Intelligence (DBI)
Malcolm Kohler
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * \<48 hours after initiation of antibiotic therapy or systemic steroid therapy
Exclusion criteria
* physical or intellectual impairment precluding informed consent or protocol adherence * known pregnancy * congenital defects with direct impact on central metabolism e.g. amino acid metabolism defect * uncontrolled diabetes (e.g. HbA1c \>11% or Glc \>20mmol/l) * acute or chronic pulmonary disease other than COPD * renal failure or renal replacement therapy (GFR \< 15 mL/min)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Exhaled Breath Metabolites | twice during 8 weeks | Number of exhaled breath features/metabolites that show a change in intensity (unit of features: mass over charge ratio) during vs after COPD exacerbation. Exhaled breath features are measured via mass spectrometer. Change is calculated as feature intensity during COPD exacerbation minus feature intensity after COPD exacerbation (8 weeks after) for each detected exhaled breath feature. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms | twice during 8 weeks | Correlation of breath metabolites with symptoms (mMRC and CAT) both measured twice during and after COPD exacerbation |
| Inflammation | twice during 8 weeks | Correlation of breath metabolites with CRP, eosinophils, and exhaled NO, all measured twice during and after COPD exacerbation |
| Causative Agents | twice during 8 weeks | Correlation of breath metabolites with sputum microbiology and viral swabs, both measured twice during and after COPD exacerbation |
| Treatment | measured once during COPD exacerbation | Correlation of breath metabolites with inhalational drugs, steroids, and antibiotics, both measured during COPD exacerbation |
Countries
Switzerland
Participant flow
Recruitment details
Patients were recruited at the University Hospital Zurich between November 2020 and April 2024. Study duration was extended due to lack of sufficient patients until July 2023.
Participants by arm
| Arm | Count |
|---|---|
| Exacerbators Patients with acute exacerbation of COPD under triple exhalation therapy | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Exacerbators |
|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 10.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Exacerbation history Number of acute COPD exacerbations | 1.3 events STANDARD_DEVIATION 0.9 |
| Exacerbation history Number of severe acute COPD exacerbations | 1.0 events STANDARD_DEVIATION 0.7 |
| GOLD ABE classification Class A | 1 Participants |
| GOLD ABE classification Class B | 4 Participants |
| GOLD ABE classification Class E | 23 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 17 Participants |
| Treatment during acute COPD exacerbation Antibiotics and systemic corticosteroids | 19 Participants |
| Treatment during acute COPD exacerbation Antibiotics only | 4 Participants |
| Treatment during acute COPD exacerbation Systemic corticosteroids only | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 35 |
| other Total, other adverse events | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
Primary
Change in Exhaled Breath Metabolites
Number of exhaled breath features/metabolites that show a change in intensity (unit of features: mass over charge ratio) during vs after COPD exacerbation. Exhaled breath features are measured via mass spectrometer. Change is calculated as feature intensity during COPD exacerbation minus feature intensity after COPD exacerbation (8 weeks after) for each detected exhaled breath feature.
Time frame: twice during 8 weeks
Population: Exhaled breath data of two participants were not analazable due to technical problems.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exacerbators | Change in Exhaled Breath Metabolites | 3298 breath metabolites |
Secondary
Causative Agents
Correlation of breath metabolites with sputum microbiology and viral swabs, both measured twice during and after COPD exacerbation
Time frame: twice during 8 weeks
Secondary
Inflammation
Correlation of breath metabolites with CRP, eosinophils, and exhaled NO, all measured twice during and after COPD exacerbation
Time frame: twice during 8 weeks
Secondary
Symptoms
Correlation of breath metabolites with symptoms (mMRC and CAT) both measured twice during and after COPD exacerbation
Time frame: twice during 8 weeks
Secondary
Treatment
Correlation of breath metabolites with inhalational drugs, steroids, and antibiotics, both measured during COPD exacerbation
Time frame: measured once during COPD exacerbation