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

M

Malcolm Kohler

Status

Completed

Conditions

COPD Exacerbation

Treatments

Other: No intervention

Study type

Observational

Funder types

Other

Identifiers

NCT04638920
BASEC-Nr. 2020-01954

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

35 participants in 1 patient group

Exacerbators
Description:
Patients with acute COPD exacerbation under triple inhalation therapy
Treatment:
Other: No intervention

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Felix Schmidt, MSc; Malcolm Kohler, MD

Data sourced from clinicaltrials.gov

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