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

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ClinicalTrials.gov Identifier: NCT04638920
Recruitment Status : Recruiting
First Posted : November 20, 2020
Last Update Posted : November 20, 2020
Sponsor:
Collaborator:
Deep Breath Initiative (DBI)
Information provided by (Responsible Party):
Malcolm Kohler, University of Zurich

Brief Summary:
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.

Condition or disease Intervention/treatment
COPD Exacerbation Other: No intervention

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Molecular Breath Print of COPD Patients With Exacerbations Despite Triple Inhalational Therapy (TripleEX)
Actual Study Start Date : September 10, 2020
Estimated Primary Completion Date : July 31, 2023
Estimated Study Completion Date : July 31, 2023

Group/Cohort Intervention/treatment
Exacerbators
Patients with COPD exacerbation
Other: No intervention
No intervention




Primary Outcome Measures :
  1. Exhaled breath metabolites [ Time Frame: twice during 8 weeks ]
    Change in exhaled breath metabolites during vs after COPD exacerbation


Secondary Outcome Measures :
  1. Symptoms [ Time Frame: twice during 8 weeks ]
    Correlation of breath metabolites with symtpoms (mMRC and CAT)

  2. Inflammation [ Time Frame: twice during 8 weeks ]
    Correlation of breath metabolites with CRP, eosinophils, exhaled NO

  3. Causative agents [ Time Frame: twice during 8 weeks ]
    Correlation of breath metabolites with sputum microbiology and viral swabs

  4. Treatment [ Time Frame: twice during 8 weeks ]
    Correlation of breath metabolites with inhalational durgs, steroids, antibiotics



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04638920


Contacts
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Contact: Malcolm Kohler, MD +41 44 255 38 28 malcolm.kohler@usz.ch
Contact: Felix Schmidt, MSc +41 44 255 48 01 felix.schmidt@usz.ch

Locations
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Switzerland
University Hospital Zurich Recruiting
Zürich, Zurich, Switzerland, 8091
Contact: Malcolm Kohler, MD    +41442553828    malcolm.kohler@usz.ch   
Contact: Felix Schmidt, MSc    +41442554801    felix.schmidt@usz.ch   
Sponsors and Collaborators
Malcolm Kohler
Deep Breath Initiative (DBI)
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Responsible Party: Malcolm Kohler, Prof. Dr. med., University of Zurich
ClinicalTrials.gov Identifier: NCT04638920    
Other Study ID Numbers: BASEC-Nr. 2020-01954
First Posted: November 20, 2020    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Malcolm Kohler, University of Zurich:
Exhaled breath analysis
Mass spectrometry