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

COPD Exacerbation Clinical Trial

— TripleEX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04638920
• Other study ID #: BASEC-Nr. 2020-01954
• Status: Recruiting
• Start date: September 10, 2020
• Est. completion date: August 31, 2024

Study information

• Verified date: November 2023
• Source: University of Zurich
• Contact: Malcolm Kohler, MD
• Phone: +41 44 255 38 28
• Email: malcolm.kohler[@]usz.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COPD Exacerbation

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zürich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
Malcolm Kohler	Deep Breath Intelligence (DBI)

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exhaled breath metabolites	Change in exhaled breath metabolites during vs after COPD exacerbation	twice during 8 weeks
Secondary	Symptoms	Correlation of breath metabolites with symtpoms (mMRC and CAT)	twice during 8 weeks
Secondary	Inflammation	Correlation of breath metabolites with CRP, eosinophils, exhaled NO	twice during 8 weeks
Secondary	Causative agents	Correlation of breath metabolites with sputum microbiology and viral swabs	twice during 8 weeks
Secondary	Treatment	Correlation of breath metabolites with inhalational durgs, steroids, antibiotics	twice during 8 weeks