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

The Institute of Molecular and Translational Medicine, Czech Republic

Status: Enrolling

Conditions: Pulmonary Cystic Fibrosis; Bronchial Asthma

Treatments: Diagnostic Test: Collection of breath condensate

Study type: Observational

Funder types: Other

Identifiers

NCT04157361

122

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

450 participants in 3 patient groups

Asthma

Description:

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.

Treatment:

Diagnostic Test: Collection of breath condensate

Cystic fibrosis

Description:

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

Treatment:

Diagnostic Test: Collection of breath condensate

Healthy control

Description:

Healthy control children/adults without chronic or autoimmune disease

Treatment:

Diagnostic Test: Collection of breath condensate