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

Condition(s) studied

Investigational drug(s) / intervention(s)

Collection of breath condensate: Breath condensate will be collected from the patients involved in study.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.
• 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.
• 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.
• 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.

Trial sites (1)

More The Institute of Molecular and Translational Medicine, Czech Republic trials in Czechia

Other trials for the same condition