Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2026-02-01 @ 1:57 PM
Study NCT ID:
NCT04157361
Status:
RECRUITING
Last Update Posted:
2025-07-18
First Post:
2019-10-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulmonary Condensate: Non-invasive Evaluation of Pulmonary Involvement in Asthma and Cystic Fibrosis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Breath condensate, serum and blood plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-17', 'studyFirstSubmitDate': '2019-10-11', 'studyFirstSubmitQcDate': '2019-11-05', 'lastUpdatePostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biomarker identification using method of High Resolution Mass Spectrometry processed on Orbitrap Velos Elite machine', 'timeFrame': '18 months from the screening', 'description': 'Biomarker iidentification in EBC using method of High Resolution Mass Spectrometry in patients with bronchial astma, cystic fibrosis and healthy control.'}, {'measure': 'FEV1 determination in Cystic Fibrosis patients', 'timeFrame': '18 months from the screening', 'description': 'Spirometry - FEV1 in Cystic Fibrosis patients and its correlation with biomarker results.'}, {'measure': 'FVC determination in Cystic Fibrosis patients', 'timeFrame': '18 months from the screening', 'description': 'Spirometry - FVC in Cystic Fibrosis patients and its correlation with biomarker results.'}, {'measure': 'Amylase readings in blood serum in Cystic Fibrosis patients', 'timeFrame': '18 months from the screening', 'description': 'Amylase readings in blood serum in Cystic Fibrosis patients and its correlation with biomarker results.'}, {'measure': 'Lipase readings in blood serum in Cystic Fibrosis patients', 'timeFrame': '18 months from the screening', 'description': 'Lipase readings in blood serum in Cystic Fibrosis patients and its correlation with biomarker results.'}, {'measure': 'Microbiology cultivation in Cystic Fibrosis patients', 'timeFrame': '18 months from the screening', 'description': 'Sampling for microbiology cultivation and determination of microbes present in EBC, correlation with biomarker results.'}, {'measure': 'CT in Cystic Fibrosis patients', 'timeFrame': '18 months from the screening', 'description': 'CT imaging of Cystic Fibrosis patients, correlation with biomarker results.'}, {'measure': 'RTG in Cystic Fibrosis patients', 'timeFrame': '18 months from the screening', 'description': 'RTG imaging of Cystic Fibrosis patients, correlation with biomarker results.'}], 'secondaryOutcomes': [{'measure': 'Inflamatory biomarker identification using method of High Resolution Mass Spectrometry processed on Orbitrap Velos Elite machine', 'timeFrame': '18 months from the screening', 'description': 'Inflamatory biomarker identification in EBC using method of High Resolution Mass Spectrometry in patients with bronchial astma, cystic fibrosis and healthy control.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breath condensate', 'Bronchial asthma', 'Cystic Fibrosis'], 'conditions': ['Bronchial Asthma', 'Pulmonary Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '* Patients with Diagnosis of Cystic Fibrosis\n* Patients with Diagnosis of Asthma\n* Healthy Controls', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children/adults with moderate or IgE mediated asthma\n* Children/adults with cystic fibrosis\n* Healthy control children/adults without lung disorders\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04157361', 'briefTitle': 'Pulmonary Condensate: Non-invasive Evaluation of Pulmonary Involvement in Asthma and Cystic Fibrosis.', 'organization': {'class': 'OTHER', 'fullName': 'The Institute of Molecular and Translational Medicine, Czech Republic'}, 'officialTitle': 'Pulmonary Condensate: A Promising Source of Proteomic Biomarkers for Non-invasive Evaluation of Pulmonary Involvement in Asthma and Cystic Fibrosis.', 'orgStudyIdInfo': {'id': '122'}}, 'armsInterventionsModule': {'armGroups': [{'label': '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.', 'interventionNames': ['Diagnostic Test: Collection of breath condensate']}, {'label': 'Cystic fibrosis', 'description': 'Children/adults with cystic fibrosis before and after antibiotics treatment and during clinical deterioration.', 'interventionNames': ['Diagnostic Test: Collection of breath condensate']}, {'label': 'Healthy control', 'description': 'Healthy control children/adults without chronic or autoimmune disease', 'interventionNames': ['Diagnostic Test: Collection of breath condensate']}], 'interventions': [{'name': 'Collection of breath condensate', 'type': 'DIAGNOSTIC_TEST', 'description': 'Breath condensate will be collected from the patients involved in study.', 'armGroupLabels': ['Asthma', 'Cystic fibrosis', 'Healthy control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77900', 'city': 'Olomouc', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Petr Dzubak, MD, PhD', 'role': 'CONTACT', 'email': 'petr.dzubak@upol.cz', 'phone': '+420 585632150'}, {'name': 'Marian Hadjuch, MD, PhD', 'role': 'CONTACT', 'email': 'marian.hajduch@upol.cz', 'phone': '+420 585632082'}], 'facility': 'University Hospital Olomouc', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}], 'centralContacts': [{'name': 'Petr Dzubak, MD, PhD.', 'role': 'CONTACT', 'email': 'petr.dzubak@upol.cz', 'phone': '585632150', 'phoneExt': '+420'}, {'name': 'Marian Hajduch, MD, PhD', 'role': 'CONTACT', 'email': 'marian.hajduch@upol.cz', 'phone': '585632', 'phoneExt': '+420'}], 'overallOfficials': [{'name': 'Petr Dzubak, MD, PhD.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Institute of Molecular and Translational Medicine, Czech Republic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Institute of Molecular and Translational Medicine, Czech Republic', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital Olomouc', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}