Pulmonary Condensate: A Promising Source of Proteomic Biomarkers for Non-invasive Evaluation of Pulmonary Involvement in Asthma and Cystic Fibrosis.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 450
- Locations
- 1
- Primary Endpoint
- Biomarker identification using method of High Resolution Mass Spectrometry processed on Orbitrap Velos Elite machine
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Children/adults with moderate or IgE mediated asthma
- •Children/adults with cystic fibrosis
- •Healthy control children/adults without lung disorders
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Biomarker identification using method of High Resolution Mass Spectrometry processed on Orbitrap Velos Elite machine
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 18 months from the screening
Spirometry - FEV1 in Cystic Fibrosis patients and its correlation with biomarker results.
FVC determination in Cystic Fibrosis patients
Time Frame: 18 months from the screening
Spirometry - FVC in Cystic Fibrosis patients and its correlation with biomarker results.
CT in Cystic Fibrosis patients
Time Frame: 18 months from the screening
CT imaging of Cystic Fibrosis patients, correlation with biomarker results.
RTG in Cystic Fibrosis patients
Time Frame: 18 months from the screening
RTG imaging of Cystic Fibrosis patients, correlation with biomarker results.
Secondary Outcomes
- Inflamatory biomarker identification using method of High Resolution Mass Spectrometry processed on Orbitrap Velos Elite machine(18 months from the screening)