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

NCT04638920 | Completed Results

• 1 other identifier: BASEC-Nr. 2020-01954
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD Exacerbation

Keywords

Exhaled breath analysis; Mass spectrometry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Symptoms

  twice during 8 weeks

• Inflammation

  twice during 8 weeks

• Causative Agents

  twice during 8 weeks

• Treatment

  measured once during COPD exacerbation

Study Arms (1)

Exacerbators

Patients with acute COPD exacerbation under triple inhalation therapy

Other: No intervention

Interventions

No intervention OTHER

No intervention

Exacerbators

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Malcolm Kohler: lead
• Deep Breath Intelligence (DBI): collaborator

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (1)

• Sievi NA, Schmidt F, Fricke K, Baur DM, Basler S, Herth J, Kohler M. Acute COPD exacerbation despite triple inhaled therapy: a molecular insight - TripleEx study. Respir Res. 2025 Sep 26;26(1):273. doi: 10.1186/s12931-025-03352-0.

  PMID: 41013424 DERIVED

Results Point of Contact

• Title: Prof. Malcolm Kohler, Sponsor-Investigator
• Organization: University Hospital Zurich

malcolm.kohler@usz.ch

+41442551111

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: November 20, 2020
• Study Start: November 16, 2020
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: April 2, 2025
• Results First Posted: April 2, 2025

Record last verified: 2025-03

Locations

CH (1)