Bronchial AsthmaNCT04157361
Pulmonary Condensate: Non-invasive Evaluation of Pulmonary Involvement in Asthma and Cystic Fibrosis.
An observational study of Bronchial Asthma and Pulmonary Cystic Fibrosis, run by The Institute of Molecular and Translational Medicine, Czech Republic at 1 site in Czechia.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Bronchial Asthma, Pulmonary Cystic Fibrosis
- What is being tested?
- Collection of breath condensate
- How many people
- 450 participants
- Where
- 1 siteCzechia
- Study dates
- 1 May 2015to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: * Patients with Diagnosis of Cystic Fibrosis * Patients with Diagnosis of Asthma * Healthy Controls
Who may be able to join
- Children/adults with moderate or IgE mediated asthma
- Children/adults with cystic fibrosis
- Healthy control children/adults without lung disorders
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Olomouc
Olomouc, 77900
Petr Dzubak, MD, PhD, +420 585632150, petr.dzubak@upol.cz
Marian Hadjuch, MD, PhD, +420 585632082, marian.hajduch@upol.cz
About this study
Official title: Pulmonary Condensate: A Promising Source of Proteomic Biomarkers for Non-invasive Evaluation of Pulmonary Involvement in Asthma and Cystic Fibrosis.
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.
Read the detailed 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.
- Conditions
- Bronchial Asthma, Pulmonary Cystic Fibrosis
- Being tested
- Collection of breath condensate
- Keywords
- Breath condensate, Bronchial asthma, Cystic Fibrosis
- Medical subject headings
- Asthma, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of breath condensateDiagnostic test
Breath condensate will be collected from the patients involved in study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Collection of breath condensate | |
| Cystic fibrosis | Children/adults with cystic fibrosis before and after antibiotics treatment and during clinical deterioration. Receives: Diagnostic Test: Collection of breath condensate | |
| Healthy control | Healthy control children/adults without chronic or autoimmune disease Receives: Diagnostic Test: Collection of breath condensate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months from the screening
FEV1 determination in Cystic Fibrosis patients
Spirometry - FEV1 in Cystic Fibrosis patients and its correlation with biomarker results.
Measured: 18 months from the screening
FVC determination in Cystic Fibrosis patients
Spirometry - FVC in Cystic Fibrosis patients and its correlation with biomarker results.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 18 months from the screening
CT in Cystic Fibrosis patients
CT imaging of Cystic Fibrosis patients, correlation with biomarker results.
Measured: 18 months from the screening
RTG in Cystic Fibrosis patients
RTG imaging of Cystic Fibrosis patients, correlation with biomarker results.
Measured: 18 months from the screening
Secondary outcomes (1)
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.
Measured: 18 months from the screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start1 May 2015
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Institute of Molecular and Translational Medicine, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Olomouc
- Responsible party
- Sponsor
- Investigators
- Petr Dzubak, MD, PhD., Study director, The Institute of Molecular and Translational Medicine, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04157361
- Sponsor's protocol ID
- 122
- Status last verified
- Jul 2025
- First submitted
- 11 Oct 2019
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Condensate: A Promising Source of Proteomic Biomarkers for Non-invasive Evaluation of Pulmonary Involvement in Asthma and Cystic Fibrosis.
- ClinicalTrials.gov ID
- NCT04157361
- Acronym / sponsor ID
- 122
- Conditions
- Bronchial Asthma, Pulmonary Cystic Fibrosis
- Keywords
- Breath condensate, Bronchial asthma, Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- The Institute of Molecular and Translational Medicine, Czech RepublicUniversity, hospital or other
- Collaborators
- University Hospital Olomouc
- Study start
- 1 May 2015 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Asthma | – | Diagnostic Test: Collection of breath condensateChildren/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 | – | Diagnostic Test: Collection of breath condensateChildren/adults with cystic fibrosis before and after antibiotics treatment and during clinical deterioration. |
| Healthy control | – | Diagnostic Test: Collection of breath condensateHealthy control children/adults without chronic or autoimmune disease |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * Patients with Diagnosis of Cystic Fibrosis * Patients with Diagnosis of Asthma * Healthy Controls
Key inclusion criteria (3 listed)
- Children/adults with moderate or IgE mediated asthma
- Children/adults with cystic fibrosis
- Healthy control children/adults without lung disorders
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of breath condensateBreath condensate will be collected from the patients involved in study. | Diagnostic test | Asthma, Cystic fibrosis, Healthy control |
Primary outcome
Biomarker identification using method of High Resolution Mass Spectrometry processed on Orbitrap Velos Elite machine
Time frame: 18 months from the screening
Biomarker iidentification in EBC using method of High Resolution Mass Spectrometry in patients with bronchial astma, cystic fibrosis and healthy control.
FEV1 determination in Cystic Fibrosis patients
Time frame: 18 months from the screening
Spirometry - FEV1 in Cystic Fibrosis patients and its correlation with biomarker results.
FVC determination in Cystic Fibrosis patients
Time frame: 18 months from the screening
Spirometry - FVC in Cystic Fibrosis patients and its correlation with biomarker results.
Amylase readings in blood serum in Cystic Fibrosis patients
Time frame: 18 months from the screening
Amylase readings in blood serum in Cystic Fibrosis patients and its correlation with biomarker results.
Lipase readings in blood serum in Cystic Fibrosis patients
Time frame: 18 months from the screening
Lipase readings in blood serum in Cystic Fibrosis patients and its correlation with biomarker results.
Microbiology cultivation in Cystic Fibrosis patients
Time frame: 18 months from the screening
Sampling for microbiology cultivation and determination of microbes present in EBC, correlation with biomarker results.
CT in Cystic Fibrosis patients
Time frame: 18 months from the screening
CT imaging of Cystic Fibrosis patients, correlation with biomarker results.
RTG in Cystic Fibrosis patients
Time frame: 18 months from the screening
RTG imaging of Cystic Fibrosis patients, correlation with biomarker results.
1 secondary outcome
Inflamatory biomarker identification using method of High Resolution Mass Spectrometry processed on Orbitrap Velos Elite machine
Time frame: 18 months from the screening
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Petr Dzubak, MD, PhD. study director
The Institute of Molecular and Translational Medicine, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchial Asthma and Pulmonary Cystic Fibrosis, run by The Institute of Molecular and Translational Medicine, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Petr Dzubak, MD, PhD. (585632150 ext. +420, petr.dzubak@upol.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarker identification using method of High Resolution Mass Spectrometry processed on Orbitrap Velos Elite machine (time frame: 18 months from the screening). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.