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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pulmonary Condensate: A Promising Source of Proteomic Biomarkers for Non-invasive Evaluation of Pulmonary Involvement in Asthma and Cystic Fibrosis.

Conditions
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Bronchial Asthma, Pulmonary Cystic Fibrosis

Intervention / Treatment
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* Diagnostic Test: Collection of breath condensate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children/adults with moderate or IgE mediated asthma Children/adults with cystic fibrosis Healthy control children/adults without lung disorders Exclusion Criteria: -
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Asthma<br>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. | Diagnostic Test: Collection of breath condensate<br>* Breath condensate will be collected from the patients involved in study.<br>|
| Cystic fibrosis<br>Children/adults with cystic fibrosis before and after antibiotics treatment and during clinical deterioration. | Diagnostic Test: Collection of breath condensate<br>* Breath condensate will be collected from the patients involved in study.<br>|
| Healthy control<br>Healthy control children/adults without chronic or autoimmune disease | Diagnostic Test: Collection of breath condensate<br>* Breath condensate will be collected from the patients involved in study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarker identification using method of High Resolution Mass Spectrometry processed on Orbitrap Velos Elite machine | Biomarker iidentification in EBC using method of High Resolution Mass Spectrometry in patients with bronchial astma, cystic fibrosis and healthy control. | 18 months from the screening | 
| FEV1 determination in Cystic Fibrosis patients | Spirometry - FEV1 in Cystic Fibrosis patients and its correlation with biomarker results. | 18 months from the screening | 
| FVC determination in Cystic Fibrosis patients | Spirometry - FVC in Cystic Fibrosis patients and its correlation with biomarker results. | 18 months from the screening | 
| Amylase readings in blood serum in Cystic Fibrosis patients | Amylase readings in blood serum in Cystic Fibrosis patients and its correlation with biomarker results. | 18 months from the screening | 
| Lipase readings in blood serum in Cystic Fibrosis patients | Lipase readings in blood serum in Cystic Fibrosis patients and its correlation with biomarker results. | 18 months from the screening | 
| Microbiology cultivation in Cystic Fibrosis patients | Sampling for microbiology cultivation and determination of microbes present in EBC, correlation with biomarker results. | 18 months from the screening | 
| CT in Cystic Fibrosis patients | CT imaging of Cystic Fibrosis patients, correlation with biomarker results. | 18 months from the screening | 
| RTG in Cystic Fibrosis patients | RTG imaging of Cystic Fibrosis patients, correlation with biomarker results. | 18 months from the screening | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflamatory biomarker identification using method of High Resolution Mass Spectrometry processed on Orbitrap Velos Elite machine | Inflamatory biomarker identification in EBC using method of High Resolution Mass Spectrometry in patients with bronchial astma, cystic fibrosis and healthy control. | 18 months from the screening | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breath condensate, Bronchial asthma, Cystic Fibrosis