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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorThe Institute of Molecular and Translational Medicine, Czech Republic

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Children/adults with moderate or IgE mediated asthma

Children/adults with cystic fibrosis

Healthy control children/adults without lung disorders

Disqualifiers

None

Trial population

* Patients with Diagnosis of Cystic Fibrosis * Patients with Diagnosis of Asthma * Healthy Controls

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Collection of breath condensate

    Diagnostic test

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

Treatment groups

450 Participants
are divided into 3 treatment groups
Group A: Asthma1 intervention
Group B: Cystic fibrosis1 intervention
Group C: Healthy control1 intervention

Trial outcomes

Primary outcomes

1

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

Biomarker iidentification in EBC using method of High Resolution Mass Spectrometry in patients with bronchial astma, cystic fibrosis and healthy control.

Time frame
18 months from the screening
2

FEV1 determination in Cystic Fibrosis patients

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

Time frame
18 months from the screening
3

FVC determination in Cystic Fibrosis patients

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

Time frame
18 months from the screening
4

Amylase readings in blood serum in Cystic Fibrosis patients

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

Time frame
18 months from the screening

Secondary outcomes

1

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

Inflamatory biomarker identification in EBC using method of High Resolution Mass Spectrometry in patients with bronchial astma, cystic fibrosis and healthy control.

Time frame
18 months from the screening

Other outcomes

Sponsors and contacts

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