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

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

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.

Study Overview

• Status: Completed
• Conditions: COPD Exacerbation
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• Switzerland
  • Zurich
    • Zürich, Zurich, Switzerland, 8091
      • University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with COPD (staged according to GOLD recommendations, aged ≥18 years) on adherent triple inhalational therapy, hospitalized due to COPD exacerbation

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Exacerbators; Patients with acute COPD exacerbation under triple inhalation therapy	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	twice during 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms	Correlation of breath metabolites with symptoms (mMRC and CAT) both measured twice during and after COPD exacerbation	twice during 8 weeks
Inflammation	Correlation of breath metabolites with CRP, eosinophils, and exhaled NO, all measured twice during and after COPD exacerbation	twice during 8 weeks
Causative Agents	Correlation of breath metabolites with sputum microbiology and viral swabs, both measured twice during and after COPD exacerbation	twice during 8 weeks
Treatment	Correlation of breath metabolites with inhalational drugs, steroids, and antibiotics, both measured during COPD exacerbation	measured once during COPD exacerbation

Collaborators and Investigators

• Sponsor: Malcolm Kohler
• Collaborators: Deep Breath Intelligence (DBI)

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2020
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (Actual): November 20, 2020

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 15, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Mass spectrometry; Exhaled breath analysis
• Other Study ID Numbers: BASEC-Nr. 2020-01954

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No