NCT05458934

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started May 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
May 2021Dec 2026

Study Start

First participant enrolled

May 11, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 14, 2022

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

August 15, 2024

Status Verified

August 1, 2024

Enrollment Period

5.6 years

First QC Date

June 30, 2022

Last Update Submit

August 14, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Molecular breath pattern

    Comparison of molecular weights of breath features from patients with different respiratory diseases

    at baseline

Secondary Outcomes (4)

  • Change in molecular breath pattern

    over one year

  • Symptoms

    at baseline

  • Inflammatory markers

    at baseline

  • Controls

    at baseline

Study Arms (2)

Lung-/Airway diseases

Patients with lung-/airway diseases

Other: No intervention

Controls

Participants without lung-/airway disease

Other: No intervention

Interventions

no intervention

ControlsLung-/Airway diseases

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

General population

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

Related Publications (1)

  • Basler S, Fricke K, Sievi NA, Arvaji A, Schmidt F, Herth J, Baur DM, Kohler M, Ulrich S, Lichtblau M. Exploring breath metabolomics as a non-invasive tool for detecting pulmonary vascular disease. Eur Heart J Open. 2025 May 23;5(3):oeaf060. doi: 10.1093/ehjopen/oeaf060. eCollection 2025 May.

Central Study Contacts

Malcolm Kohler, MD

CONTACT

Noriane Sievi, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2022

First Posted

July 14, 2022

Study Start

May 11, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

August 15, 2024

Record last verified: 2024-08

Locations