Molecular Breath Print of COPD Patients With Exacerbations Despite Triple Inhalational Therapy

Completed

• Conditions: COPD Exacerbation
• Interventions: Other: No intervention

• Registration Number: NCT04638920
• Lead Sponsor: Malcolm Kohler

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-16
• Study First Submitted: 2020-11-16
• Study First Submitted QC: 2020-11-16
• Study First Posted: 2020-11-20
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Results First Submitted: 2025-01-29
• Status Verified: 2025-03
• Results First Submitted QC: 2025-03-15
• Last Update Submitted: 2025-03-15
• Results First Posted: 2025-04-02
• Last Update Posted: 2025-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exacerbators	No intervention	Patients with COPD exacerbation

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital Zurich; 🇨🇭 Zürich, Zurich, Switzerland