Analysis of Exhaled Breath From Patients With Lung-/Airway Diseases (BigExBrESs)

Recruiting

• Conditions: Lung-/Airway Diseases
• Interventions: Other: No intervention

• Registration Number: NCT05458934
• Lead Sponsor: University of Zurich

Brief Summary

Ananlyis of exhaled breath of patients with lung-/airway diseases to identify and distinguish respiratory diseases, and improve the disease manangament.

Detailed Description

Breath analysis offers a unique opportunity to non-invasively retrieve unlimited samples of relevant information on the ongoing internal biochemical processes, as parts of the most volatile components in blood reach the gas phase and are subsequently exhaled (e.g. detection of ethanol in breath). Analysis of exhaled breath provides biochemical information about the metabolism and the pathophysiological state. Chemical analysis of exhaled breath with mass spectrometry identified numerous volatile organic compounds (VOCs) \[low molecular weightcomponents:\< 500 Dalton (Da)\]. Using Big Data analytics, specific patterns of diverse respiratory disease (e.g. for COPD and asthma) can be identified and the different diseases can be distinguished from each other. Specific Big Data Analytics might also improve the management of disease (e.g.avoiding of exacerbations) by identifying early signs of exacerbation risk.

Study Timeline

• Study Start: 2021-05-11
• Study First Submitted: 2022-06-30
• Study First Submitted QC: 2022-07-13
• Study First Posted: 2022-07-14
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-15
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• Signed informed consent
• Age ≥ 18 years at study entry

Exclusion Criteria

• Physical or intellectual impairment precluding informed consent or protocol adherence
• Known pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls	No intervention	Participants without lung-/airway disease
Lung-/Airway diseases	No intervention	Patients with lung-/airway diseases

Primary Outcome Measures

Name	Time	Method
Molecular breath pattern	at baseline	Comparison of molecular weights of breath features from patients with different respiratory diseases

Secondary Outcome Measures

Name	Time	Method
Controls	at baseline	Differentiation of molecular breath pattern (m/z ratios of molecules in exhaled breath) between diseased patients and participants without respiratory disease (untargeted approach)
Symptoms	at baseline	Correlation/Association of molecular weights of specific breath features with symptoms (e.g. dyspnea)
Change in molecular breath pattern	over one year	Change in the molecular breath pattern during the course of the disease (untargeted approach)
Inflammatory markers	at baseline	Correlation/Association of molecular weights of specific breath features with inflammatory markers (e.g. eosinophils)

Trial Locations

Locations (1)

University Hospital Zurich; 🇨🇭 Zürich, Zurich, Switzerland