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

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ClinicalTrials.gov Identifier: NCT04157361
Recruitment Status : Recruiting
First Posted : November 8, 2019
Last Update Posted : November 15, 2019
Sponsor:
Collaborator:
University Hospital Olomouc
Information provided by (Responsible Party):
The Institute of Molecular and Translational Medicine, Czech Republic

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.

Condition or disease Intervention/treatment
Bronchial Asthma Pulmonary Cystic Fibrosis Diagnostic Test: Collection of breath condensate

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.

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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pulmonary Condensate: A Promising Source of Proteomic Biomarkers for Non-invasive Evaluation of Pulmonary Involvement in Asthma and Cystic Fibrosis.
Actual Study Start Date : May 1, 2015
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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.
Diagnostic Test: Collection of breath condensate
Breath condensate will be collected from the patients involved in study.

Healthy control
Healthy control children/adults without chronic or autoimmune disease
Diagnostic Test: Collection of breath condensate
Breath condensate will be collected from the patients involved in study.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. CT in Cystic Fibrosis patients [ Time Frame: 18 months from the screening ]
    CT imaging of Cystic Fibrosis patients, correlation with biomarker results.

  8. RTG in Cystic Fibrosis patients [ Time Frame: 18 months from the screening ]
    RTG imaging of Cystic Fibrosis patients, correlation with biomarker results.


Secondary Outcome Measures :
  1. Inflamatory biomarker identification using method of High Resolution Mass Spectrometry processed on Orbitrap Velos Elite machine [ Time Frame: 18 months from the screening ]
    Inflamatory biomarker identification in EBC using method of High Resolution Mass Spectrometry in patients with bronchial astma, cystic fibrosis and healthy control.


Biospecimen Retention:   Samples Without DNA
Breath condensate, serum and blood plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
  • Patients with Diagnosis of Cystic Fibrosis
  • Patients with Diagnosis of Asthma
  • Healthy Controls
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04157361


Contacts
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Contact: Petr Dzubak, MD, PhD. 585632150 ext +420 petr.dzubak@upol.cz
Contact: Marian Hajduch, MD, PhD 585632 ext +420 marian.hajduch@upol.cz

Locations
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Czechia
University Hospital Olomouc Recruiting
Olomouc, Czechia, 77900
Contact: Petr Dzubak, MD, PhD    +420 585632150    petr.dzubak@upol.cz   
Contact: Marian Hadjuch, MD, PhD    +420 585632082    marian.hajduch@upol.cz   
Sponsors and Collaborators
The Institute of Molecular and Translational Medicine, Czech Republic
University Hospital Olomouc
Investigators
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Study Director: Petr Dzubak, MD, PhD. The Institute of Molecular and Translational Medicine, Czech Republic

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Responsible Party: The Institute of Molecular and Translational Medicine, Czech Republic
ClinicalTrials.gov Identifier: NCT04157361     History of Changes
Other Study ID Numbers: 122
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Institute of Molecular and Translational Medicine, Czech Republic:
Breath condensate
Bronchial asthma
Cystic Fibrosis
Additional relevant MeSH terms:
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Cystic Fibrosis
Asthma
Fibrosis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases