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

NCT04157361 | Recruiting

• 1 other identifier: 122
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchial Asthma; Pulmonary Cystic Fibrosis

Keywords

Breath condensate; Bronchial asthma; Cystic Fibrosis

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• Inflamatory biomarker identification using method of High Resolution Mass Spectrometry processed on Orbitrap Velos Elite machine

  18 months from the screening

Study Arms (3)

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

Cystic fibrosis

Children/adults with cystic fibrosis before and after antibiotics treatment and during clinical deterioration.

Diagnostic Test: Collection of breath condensate

Healthy control

Healthy control children/adults without chronic or autoimmune disease

Diagnostic Test: Collection of breath condensate

Interventions

Collection of breath condensate DIAGNOSTIC_TEST

Breath condensate will be collected from the patients involved in study.

Asthma; Cystic fibrosis; Healthy control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• The Institute of Molecular and Translational Medicine, Czech Republic: lead
• University Hospital Olomouc: collaborator

Study Sites (1)

University Hospital Olomouc

Olomouc, 77900, Czechia

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Breath condensate, serum and blood plasma

MeSH Terms

Conditions

Asthma; Cystic Fibrosis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pancreatic Diseases; Digestive System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Petr Dzubak, MD, PhD.

  The Institute of Molecular and Translational Medicine, Czech Republic

  STUDY DIRECTOR

Central Study Contacts

Petr Dzubak, MD, PhD.

CONTACT

585632150; petr.dzubak@upol.cz

Marian Hajduch, MD, PhD

CONTACT

585632; marian.hajduch@upol.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: November 8, 2019
• Study Start: May 1, 2015
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 23, 2026

Record last verified: 2025-07

Locations

CZ (1)