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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	N/A and Over
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04157361
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	The Institute of Molecular and Translational Medicine, Czech Republic
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Petr Dzubak, MD, PhD.
Principal Investigator Affiliation	The Institute of Molecular and Translational Medicine, Czech Republic
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Czechia
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Bronchial Asthma, Pulmonary Cystic Fibrosis

Additional Details

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.

Arms & Interventions

Arms

: 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.

: Cystic fibrosis

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

: Healthy control

Healthy control children/adults without chronic or autoimmune disease

Interventions

Diagnostic Test: - Collection of breath condensate

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

Contact a Trial Team

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