Pulmonary Condensate: Non-invasive Evaluation of Pulmonary Involvement in Asthma and Cystic Fibrosis.

Pulmonary Condensate: A Promising Source of Proteomic Biomarkers for Non-invasive Evaluation of Pulmonary Involvement in Asthma and Cystic Fibrosis.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04157361

Enrollment

450

Registered

2019-11-08

Start date

2015-05-01

Completion date

2026-12-31

Last updated

2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchial Asthma, Pulmonary Cystic Fibrosis

Keywords

Breath condensate, Bronchial asthma, Cystic Fibrosis

Brief summary

Exhaled breath condensate (EBC) represents a rich source for countless biomarkers that can provide valuable information about respiratory as well as systemic diseases. Finding non-invasive methods for early detection of lung injury, inflammation and infectious complications in chronic diseases like (CF) Cystic fibrosis or (AB) Bronchial asthma would be highly beneficial. Investigators propose to establish EBC "breathprints" revealing molecular signatures of pulmonary inflammation and specific respiratory bacterial infections of CF patients and AB. Investigators hypothesize that the analysis of EBC can reveal biomarkers specific for severity of the inflammation, and infection caused by opportunistic pathogens such as P. aeruginosa (PA). With these breath-prints, investigators also propose to establish correlations between respiratory microbiota using traditional methods and CF lung disease severity. Together, the studies will advance the development and validation of EBC as a novel tool for the proper diagnosis of AB and monitoring of CF disease activity, treatment efficacy and PA or another opportunistic infections.

Detailed description

Exhaled breath condensate (EBC) represents a rich source for countless biomarkers that can provide valuable information about respiratory as well as systemic diseases. Finding non-invasive methods for early detection of lung injury, inflammation and infectious complications in chronic diseases like Cystic fibrosis (CF) or Bronchial asthma (AB) would be highly beneficial. Investigators propose to establish EBC "breathprints" revealing molecular signatures of pulmonary inflammation and specific respiratory bacterial infections of CF patients and AB. Investigators hypothesize that the analysis of EBC can reveal biomarkers specific for severity of the inflammation, and infection caused by opportunistic pathogens such as P. aeruginosa (PA). With these breath-prints, investigators also propose to establish correlations between respiratory microbiota using traditional methods and CF lung disease severity. Together, the studies will advance the development and validation of EBC as a novel tool for the proper diagnosis of AB and monitoring of CF disease activity, treatment efficacy and PA or another opportunistic infections.

Interventions

DIAGNOSTIC_TESTCollection of breath condensate

Breath condensate will be collected from the patients involved in study.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

Inclusion criteria

* Children/adults with moderate or IgE mediated asthma * Children/adults with cystic fibrosis * Healthy control children/adults without lung disorders

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
Biomarker identification using method of High Resolution Mass Spectrometry processed on Orbitrap Velos Elite machine	18 months from the screening	Biomarker iidentification in EBC using method of High Resolution Mass Spectrometry in patients with bronchial astma, cystic fibrosis and healthy control.
FEV1 determination in Cystic Fibrosis patients	18 months from the screening	Spirometry - FEV1 in Cystic Fibrosis patients and its correlation with biomarker results.
FVC determination in Cystic Fibrosis patients	18 months from the screening	Spirometry - FVC in Cystic Fibrosis patients and its correlation with biomarker results.
Amylase readings in blood serum in Cystic Fibrosis patients	18 months from the screening	Amylase readings in blood serum in Cystic Fibrosis patients and its correlation with biomarker results.
Lipase readings in blood serum in Cystic Fibrosis patients	18 months from the screening	Lipase readings in blood serum in Cystic Fibrosis patients and its correlation with biomarker results.
Microbiology cultivation in Cystic Fibrosis patients	18 months from the screening	Sampling for microbiology cultivation and determination of microbes present in EBC, correlation with biomarker results.
CT in Cystic Fibrosis patients	18 months from the screening	CT imaging of Cystic Fibrosis patients, correlation with biomarker results.
RTG in Cystic Fibrosis patients	18 months from the screening	RTG imaging of Cystic Fibrosis patients, correlation with biomarker results.

Secondary

Measure	Time frame	Description
Inflamatory biomarker identification using method of High Resolution Mass Spectrometry processed on Orbitrap Velos Elite machine	18 months from the screening	Inflamatory biomarker identification in EBC using method of High Resolution Mass Spectrometry in patients with bronchial astma, cystic fibrosis and healthy control.

Countries

Czechia

Contacts

CONTACTPetr Dzubak, MD, PhD.

petr.dzubak@upol.cz585632150

CONTACTMarian Hajduch, MD, PhD

marian.hajduch@upol.cz585632

STUDY_DIRECTORPetr Dzubak, MD, PhD.

The Institute of Molecular and Translational Medicine, Czech Republic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026