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

Bronchial Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04157361
• Other study ID #: 122
• Status: Recruiting
• Start date: May 1, 2015
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2023
• Source: The Institute of Molecular and Translational Medicine, Czech Republic
• Contact: Petr Dzubak, MD, PhD.
• Phone: 585632150
• Email: petr.dzubak[@]upol.cz
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Children/adults with moderate or IgE mediated asthma

• Children/adults with cystic fibrosis

• Healthy control children/adults without lung disorders

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma
• Cystic Fibrosis
• Fibrosis
• Pulmonary Cystic Fibrosis

Intervention

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

Locations

Country	Name	City	State
Czechia	University Hospital Olomouc	Olomouc

Sponsors (2)

Lead Sponsor	Collaborator
The Institute of Molecular and Translational Medicine, Czech Republic	University Hospital Olomouc

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	FEV1 determination in Cystic Fibrosis patients	Spirometry - FEV1 in Cystic Fibrosis patients and its correlation with biomarker results.	18 months from the screening
Primary	FVC determination in Cystic Fibrosis patients	Spirometry - FVC in Cystic Fibrosis patients and its correlation with biomarker results.	18 months from the screening
Primary	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
Primary	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
Primary	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
Primary	CT in Cystic Fibrosis patients	CT imaging of Cystic Fibrosis patients, correlation with biomarker results.	18 months from the screening
Primary	RTG in Cystic Fibrosis patients	RTG imaging of Cystic Fibrosis patients, correlation with biomarker results.	18 months from the screening
Secondary	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