Clinical trial NCT04157361: Pulmonary Condensate: Non-invasive Evaluation of Pulmonary Involvement in Asthma and Cystic Fibrosis.
Official title: Pulmonary Condensate: A Promising Source of Proteomic Biomarkers for Non-invasive Evaluation of Pulmonary Involvement in Asthma and Cystic Fibrosis.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bronchial Asthma
Pulmonary Cystic Fibrosis
Keywords: Breath condensate
Bronchial asthma
Cystic Fibrosis
Lead sponsor: The Institute of Molecular and Translational Medicine, Czech Republic
Sponsor class: OTHER
Collaborators: name: University Hospital Olomouc
First posted: 2019-11-08
Enrollment: 450
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * Patients with Diagnosis of Cystic Fibrosis
* Patients with Diagnosis of Asthma
* Healthy Controls

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Biomarker identification using method of High Resolution Mass Spectrometry processed on Orbitrap Velos Elite machine
timeFrame: 18 months from the screening
measure: FEV1 determination in Cystic Fibrosis patients
timeFrame: 18 months from the screening
measure: FVC determination in Cystic Fibrosis patients
timeFrame: 18 months from the screening
measure: Amylase readings in blood serum in Cystic Fibrosis patients
timeFrame: 18 months from the screening
measure: Lipase readings in blood serum in Cystic Fibrosis patients
timeFrame: 18 months from the screening
measure: Microbiology cultivation in Cystic Fibrosis patients
timeFrame: 18 months from the screening
measure: CT in Cystic Fibrosis patients
timeFrame: 18 months from the screening
measure: RTG in Cystic Fibrosis patients
timeFrame: 18 months from the screening
Secondary outcomes:
measure: Inflamatory biomarker identification using method of High Resolution Mass Spectrometry processed on Orbitrap Velos Elite machine
timeFrame: 18 months from the screening
Other outcomes:
Locations:
city: Olomouc
country: Czechia
facility: University Hospital Olomouc
Study officials:
affiliation: The Institute of Molecular and Translational Medicine, Czech Republic
name: Petr Dzubak, MD, PhD.
role: STUDY_DIRECTOR
References: