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

NCT ID: NCT04157361

Last Updated: 2025-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bronchial Asthma Pulmonary Cystic Fibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Collection of breath condensate

Intervention Type DIAGNOSTIC_TEST

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.

Collection of breath condensate

Intervention Type DIAGNOSTIC_TEST

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

Healthy control

Healthy control children/adults without chronic or autoimmune disease

Collection of breath condensate

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Collection of breath condensate

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Olomouc

OTHER

Sponsor Role collaborator

The Institute of Molecular and Translational Medicine, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Petr Dzubak, MD, PhD.

Role: STUDY_DIRECTOR

The Institute of Molecular and Translational Medicine, Czech Republic

Locations

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University Hospital Olomouc

Olomouc, , Czechia

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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Petr Dzubak, MD, PhD.

Role: CONTACT

585632150 ext. +420

Marian Hajduch, MD, PhD

Role: CONTACT

585632 ext. +420

Facility Contacts

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Petr Dzubak, MD, PhD

Role: primary

+420 585632150

Marian Hadjuch, MD, PhD

Role: backup

+420 585632082

Other Identifiers

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122

Identifier Type: -

Identifier Source: org_study_id

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