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NCT Number: NCT04157361

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Collection of breath condensate

Diagnostic Test

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

Primary outcomes

  1. Biomarker identification using method of High Resolution Mass Spectrometry processed on Orbitrap Velos Elite machine

    Time frame: 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.

  2. FEV1 determination in Cystic Fibrosis patients

    Time frame: 18 months from the screening

    Spirometry - FEV1 in Cystic Fibrosis patients and its correlation with biomarker results.

  3. FVC determination in Cystic Fibrosis patients

    Time frame: 18 months from the screening

    Spirometry - FVC in Cystic Fibrosis patients and its correlation with biomarker results.

  4. Amylase readings in blood serum in Cystic Fibrosis patients

    Time frame: 18 months from the screening

    Amylase readings in blood serum in Cystic Fibrosis patients and its correlation with biomarker results.

  5. Lipase readings in blood serum in Cystic Fibrosis patients

    Time frame: 18 months from the screening

    Lipase readings in blood serum in Cystic Fibrosis patients and its correlation with biomarker results.

  6. Microbiology cultivation in Cystic Fibrosis patients

    Time frame: 18 months from the screening

    Sampling for microbiology cultivation and determination of microbes present in EBC, correlation with biomarker results.

  7. CT in Cystic Fibrosis patients

    Time frame: 18 months from the screening

    CT imaging of Cystic Fibrosis patients, correlation with biomarker results.

  8. RTG in Cystic Fibrosis patients

    Time frame: 18 months from the screening

    RTG imaging of Cystic Fibrosis patients, correlation with biomarker results.

Secondary outcomes

  1. Inflamatory biomarker identification using method of High Resolution Mass Spectrometry processed on Orbitrap Velos Elite machine

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marian Hajduch, MD, PhD

CONTACT

[email protected]

585632 ext. +420

Petr Dzubak, MD, PhD.

CONTACT

[email protected]

585632150 ext. +420

Sponsors and collaborators

Lead sponsor

The Institute of Molecular and Translational Medicine, Czech Republic

Other

Collaborators

  • University Hospital Olomouc

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2026
Study completion
2026
First posted
Nov 8, 2019
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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