Pulmonary Condensate: Non-invasive Evaluation of Pulmonary Involvement in Asthma and Cystic Fibrosis.
- Conditions
- Bronchial AsthmaPulmonary Cystic Fibrosis
- Interventions
- Diagnostic Test: Collection of breath condensate
- Registration Number
- NCT04157361
- Lead Sponsor
- The Institute of Molecular and Translational Medicine, Czech Republic
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 450
- Children/adults with moderate or IgE mediated asthma
- Children/adults with cystic fibrosis
- Healthy control children/adults without lung disorders
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Asthma Collection of breath condensate Children/adults with moderate or IgE mediated asthma with inhaled and/or food allergies before and during inhaled corticosteroid, leukotriene modifiers or long-acting beta agonists treatment. Healthy control Collection of breath condensate Healthy control children/adults without chronic or autoimmune disease Cystic fibrosis Collection of breath condensate Children/adults with cystic fibrosis before and after antibiotics treatment and during clinical deterioration.
- Primary Outcome Measures
Name Time Method 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.
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.
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.
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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
University Hospital Olomouc
🇨🇿Olomouc, Czechia