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OpenTrials
Completed

NCT Number: NCT04638920

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

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.

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Key information

Conditions

COPD Exacerbation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Change in Exhaled Breath Metabolites

    Time frame: 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 outcomes

  1. Symptoms

    Time frame: twice during 8 weeks

    Correlation of breath metabolites with symptoms (mMRC and CAT) both measured twice during and after COPD exacerbation

  2. Inflammation

    Time frame: twice during 8 weeks

    Correlation of breath metabolites with CRP, eosinophils, and exhaled NO, all measured twice during and after COPD exacerbation

  3. Causative Agents

    Time frame: twice during 8 weeks

    Correlation of breath metabolites with sputum microbiology and viral swabs, both measured twice during and after COPD exacerbation

  4. Treatment

    Time frame: measured once during COPD exacerbation

    Correlation of breath metabolites with inhalational drugs, steroids, and antibiotics, both measured during COPD exacerbation

Sponsors and collaborators

Lead sponsor

Malcolm Kohler

Other

Collaborators

  • Deep Breath Intelligence (DBI)

Registry information

Official study title

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

Acronym: TripleEX

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Nov 20, 2020
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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