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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bronchial Asthma; Pulmonary Cystic Fibrosis
• Intervention / Treatment: Diagnostic test: Collection of breath condensate

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 Type: Observational
• Enrollment (Estimated): 450

Contacts and Locations

• Study Contact: Name: Petr Dzubak, MD, PhD.; Phone Number: +420 585632150; Email: petr.dzubak@upol.cz
• Study Contact Backup: Name: Marian Hajduch, MD, PhD; Phone Number: +420 585632; Email: marian.hajduch@upol.cz

Study Locations

• Czechia
  • Olomouc, Czechia, 77900
    • Recruiting
    • University Hospital Olomouc
    • Contact: Petr Dzubak, MD, PhD; Phone Number: +420 585632150; Email: petr.dzubak@upol.cz
    • Contact: Marian Hadjuch, MD, PhD; Phone Number: +420 585632082; Email: marian.hajduch@upol.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

• Patients with Diagnosis of Cystic Fibrosis
• Patients with Diagnosis of Asthma
• Healthy Controls

Description

Inclusion Criteria:

• Children/adults with moderate or IgE mediated asthma
• Children/adults with cystic fibrosis
• Healthy control children/adults without lung disorders

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Asthma; 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; Breath condensate will be collected from the patients involved in study.
Cystic fibrosis; Children/adults with cystic fibrosis before and after antibiotics treatment and during clinical deterioration.	Diagnostic test: Collection of breath condensate; Breath condensate will be collected from the patients involved in study.
Healthy control; Healthy control children/adults without chronic or autoimmune disease	Diagnostic test: Collection of breath condensate; Breath condensate will be collected from the patients involved in study.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Institute of Molecular and Translational Medicine, Czech Republic
• Collaborators: University Hospital Olomouc
• Investigators: Study Director: Petr Dzubak, MD, PhD., The Institute of Molecular and Translational Medicine, Czech Republic

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: October 11, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (Actual): November 8, 2019

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Cystic Fibrosis; Bronchial asthma; Breath condensate
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Infant, Newborn, Diseases; Bronchial Diseases; Genetic Diseases, Inborn; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Pancreatic Diseases; Fibrosis; Asthma; Cystic Fibrosis
• Other Study ID Numbers: 122 (Council for Stem Cell Sciences and Technologies)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No