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 ionisation mass spectrometry (SESIHRMS) during and 8 weeks after a COPD exacerbation. Furthermore, breath patterns will be assessed for correlation and association to clinical outcomes and treatment.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Malcolm Kohler, MD; Phone Number: +41 44 255 38 28; Email: malcolm.kohler@usz.ch
• Study Contact Backup: Name: Felix Schmidt, MSc; Phone Number: +41 44 255 48 01; Email: felix.schmidt@usz.ch

Study Locations

• Switzerland
  • Zurich
    • Zürich, Zurich, Switzerland, 8091
      • Recruiting
      • University Hospital Zürich
      • Contact: Malcolm Kohler, MD; Phone Number: +41442553828; Email: malcolm.kohler@usz.ch
      • Contact: Felix Schmidt, MSc; Phone Number: +41442554801; Email: felix.schmidt@usz.ch

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, risk groups A-D
• 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 COPD exacerbation	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exhaled breath metabolites	Change in exhaled breath metabolites during vs after COPD exacerbation	twice during 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms	Correlation of breath metabolites with symtpoms (mMRC and CAT)	twice during 8 weeks
Inflammation	Correlation of breath metabolites with CRP, eosinophils, exhaled NO	twice during 8 weeks
Causative agents	Correlation of breath metabolites with sputum microbiology and viral swabs	twice during 8 weeks
Treatment	Correlation of breath metabolites with inhalational durgs, steroids, antibiotics	twice during 8 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2020
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): August 31, 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): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

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