Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2026-01-18 @ 8:09 AM
Study NCT ID:
NCT03025061
Status:
COMPLETED
Last Update Posted:
2018-09-05
First Post:
2017-01-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Within-day and Between-day Repeatability of the Breath Pattern in Healthy Children and in Children With Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-03', 'studyFirstSubmitDate': '2017-01-16', 'studyFirstSubmitQcDate': '2017-01-16', 'lastUpdatePostDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Electronic nose measurements', 'timeFrame': '1 week', 'description': 'Several volatile organic compounds, including isoprene, 1,2-pentadiene, acetone, ethanol, pentane and ethane, identified in exhaled breath.'}], 'secondaryOutcomes': [{'measure': 'Fraction of Exhaled Nitric Oxide (FeNO)', 'timeFrame': '1 week'}, {'measure': 'Pulmonary function (FEV1, FVC, etc.)', 'timeFrame': '1 week'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Breath pattern', 'Children', 'Repeatability'], 'conditions': ['Asthma', 'Healthy']}, 'referencesModule': {'references': [{'pmid': '30965288', 'type': 'DERIVED', 'citation': 'Fasola S, Ferrante G, Sabatini A, Santonico M, Zompanti A, Grasso S, Antonelli Incalzi R, La Grutta S. Repeatability of exhaled breath fingerprint collected by a modern sampling system in asthmatic and healthy children. J Breath Res. 2019 May 1;13(3):036007. doi: 10.1088/1752-7163/ab1765.'}]}, 'descriptionModule': {'briefSummary': '"Within-day and Between-day Repeatability of the Breath Pattern in Healthy Children and in Children With Moderate Asthma" is an observational prospective study in outpatient clinic of Pediatric Allergology \\& Pulmonology (PAP) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (IBIM CNR), Italy.\n\nThe electronic nose (E-nose) has been proposed as a novel, non-invasive tool to evaluate the level of airway inflammation for different respiratory diseases, especially in children. To date, there are no data on the within-day and the between-day repeatability of the breath pattern in healthy children and in children with moderate asthma.\n\nThe breath pattern will be analyzed by collecting, for each child, three samples of the breath through the E-nose. Within-day repeatability will be assessed using two consecutive measurements (the second one after 30 minutes). Between-day repeatability will be assessed using a third measurement repeated after 7 days.\n\nThe study is expected to provide information about the accuracy of E-nose measurements for a child population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A study population of 15 asthmatic children (moderate asthma) attending the outpatient clinic of Pediatric Allergology \\& Pulmonology (PAP) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (IBIM CNR).\n\nA control group of healthy children (n=30), recruited from the primary schools involved in the municipal project "educational pathways" (Palermo, Italy) to which the PAP group partecipates.', 'healthyVolunteers': False, 'eligibilityCriteria': 'The inclusion criteria for asthmatic children are:\n\n1. Moderate asthma (GINA 2015);\n2. Age 6-11 years;\n3. No upper airway respiratory infections or exacerbations in the last 4 weeks;\n4. Steroid-naive asthma;\n5. Positive bronchodilator response;\n6. Non smoker.\n\nThe inclusion criteria for healthy children are:\n\n1. Age 6-11 years;\n2. No upper airway respiratory infections in the last 4 weeks;\n3. Non smoker;\n4. No history of asthma and respiratory diseases during the life;\n5. Negative bronchodilator response.\n\nThe exclusion criteria are:\n\n1. Symptoms of acute respiratory infection;\n2. Immunological and metabolic systemic disease;\n3. Major malformations of the upper airways;\n4. Active smoker.'}, 'identificationModule': {'nctId': 'NCT03025061', 'acronym': 'CERS', 'briefTitle': 'Within-day and Between-day Repeatability of the Breath Pattern in Healthy Children and in Children With Asthma', 'organization': {'class': 'OTHER', 'fullName': "Istituto per la Ricerca e l'Innovazione Biomedica"}, 'officialTitle': 'Within-day and Between-day Repeatability of the Breath Pattern in Healthy Children and in Children With Moderate Asthma', 'orgStudyIdInfo': {'id': '5/2016'}}, 'armsInterventionsModule': {'armGroups': [{'label': '15 children with moderate asthma', 'description': 'Assessment of E-nose measurements: three E-nose measurements on 15 children with moderate asthma (of both sex and 6-11 years old): first measurement, second one after 30 minutes, third one after 7 days. These children attend the outpatient clinic of Pediatric Allergology \\& Pulmonology (PAP) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (IBIM CNR).', 'interventionNames': ['Other: Assessment of E-nose measurements']}, {'label': '30 healthy children', 'description': 'Assessment of E-nose measurements: three E-nose measurements on 30 healthy children (of both sex and 6-11 years old): first measurement, second one after 30 minutes, third one after 7 days. These children attend the primary schools involved in the municipal project "Educational Pathways" (Palermo).', 'interventionNames': ['Other: Assessment of E-nose measurements']}], 'interventions': [{'name': 'Assessment of E-nose measurements', 'type': 'OTHER', 'description': 'Breath sampling through E-nose pneumopipe', 'armGroupLabels': ['15 children with moderate asthma', '30 healthy children']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90146', 'city': 'Palermo', 'state': 'Sicily', 'country': 'Italy', 'facility': 'Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Istituto per la Ricerca e l'Innovazione Biomedica", 'class': 'OTHER'}, 'collaborators': [{'name': 'Campus Bio-Medico University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD. Senior Researcher. Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.', 'investigatorFullName': 'Stefania La Grutta, MD', 'investigatorAffiliation': "Istituto per la Ricerca e l'Innovazione Biomedica"}}}}