Pulmonary Condensate: Non-invasive Evaluation of Pulmonary Involvement in Asthma and Cystic Fibrosis.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Collection of breath condensate.
- Who it may be relevant to
- Registry conditions: Bronchial Asthma, Pulmonary Cystic Fibrosis. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pulmonary Condensate: A Promising Source of Proteomic Biomarkers for Non-invasive Evaluation of Pulmonary Involvement in Asthma and Cystic Fibrosis.
Overview
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 test Collection of breath condensate
Breath condensate will be collected from the patients involved in study.
Primary outcome measures
- Biomarker identification using method of High Resolution Mass Spectrometry processed on Orbitrap Velos Elite machine [Time frame: 18 months from the screening]
- FEV1 determination in Cystic Fibrosis patients [Time frame: 18 months from the screening]
- FVC determination in Cystic Fibrosis patients [Time frame: 18 months from the screening]
- Amylase readings in blood serum in Cystic Fibrosis patients [Time frame: 18 months from the screening]
- Lipase readings in blood serum in Cystic Fibrosis patients [Time frame: 18 months from the screening]
- Microbiology cultivation in Cystic Fibrosis patients [Time frame: 18 months from the screening]
- CT in Cystic Fibrosis patients [Time frame: 18 months from the screening]
- RTG in Cystic Fibrosis patients [Time frame: 18 months from the screening]
Secondary outcome measures (1)
- Inflamatory biomarker identification using method of High Resolution Mass Spectrometry processed on Orbitrap Velos Elite machine [Time frame: 18 months from the screening]
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
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Czechia · 1 center
- University Hospital Olomouc — Olomouc
Identifiers
NCT: NCT04157361 · 122