Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-02-22 @ 12:23 PM
Study NCT ID:
NCT02453750
Status:
COMPLETED
Last Update Posted:
2019-01-31
First Post:
2015-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Airway Inflammation in Congenital Diaphragmatic Hernia Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065630', 'term': 'Hernias, Diaphragmatic, Congenital'}, {'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006548', 'term': 'Hernia, Diaphragmatic'}, {'id': 'D000082122', 'term': 'Internal Hernia'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'theo.moraes@sickkids.ca', 'phone': '416 813 2196', 'title': 'Dr Theo Moraes', 'organization': 'SickKids'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Hypersaline and Bronchodilator Response', 'description': 'After the subject has performed post-bronchodilator spirometry, they will inhale 5 mls of 3% hypertonic saline for 7 minutes by nebulizer.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Elevated Sputum Eosinophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypersaline and Bronchodilator Response', 'description': 'everyone performs sputum induction'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'post sputum induction', 'description': 'Number of participants with sputum eosinophils greater than 3% percent of cells in the sputum', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '15 gave reasonable sputum for analysis, none had elevated sputum eosinophils'}, {'type': 'SECONDARY', 'title': 'Number of Participant With Elevated Sputum Neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypersaline and Bronchodilator Response', 'description': 'After the subject has performed post-bronchodilator spirometry, they will inhale 5 mls of 3% hypertonic saline for 7 minutes by nebulizer.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, +30 minutes', 'description': 'Elevation is defined as sputum neutrophils \\> or = 61% neutrophils = neutrophilic inflammation', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '15 gave reasonable sputum'}, {'type': 'SECONDARY', 'title': 'Number of Participant With Elevated Exhaled Nitric Oxide (NO) Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypersaline and Bronchodilator Response', 'description': 'eNO measured'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 min', 'description': 'exhaled NO measurements will be performed according to the American Thoracic Society and European Respiratory Society guidelines. These tests are performed routinely as part of the respiratory evaluation of these patients and are not additional tests added for this study.\n\ngreater than 20 ppb was considered elevated', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'only 12 performed eNO'}, {'type': 'SECONDARY', 'title': 'Number of Participant With Bronchodilator Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypersaline and Bronchodilator Response', 'description': 'spiro performed at start of visit'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'life time of child (age 6 to present age)', 'description': 'defined as a = or \\> 12% change in FEV1 post bronchodilator', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all subjects performed PFTs'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hypersaline and Bronchodilator Response', 'description': 'Each child will perform a sputum induction to obtain cells for analysis.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Hypersaline and Bronchodilator Response', 'description': 'After the subject has performed post-bronchodilator spirometry, they will inhale 5 mls of 3% hypertonic saline for 7 minutes by nebulizer to obtain cells for analysis.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-15', 'studyFirstSubmitDate': '2015-05-21', 'resultsFirstSubmitDate': '2017-10-06', 'studyFirstSubmitQcDate': '2015-05-21', 'lastUpdatePostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-15', 'studyFirstPostDateStruct': {'date': '2015-05-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Elevated Sputum Eosinophils', 'timeFrame': 'post sputum induction', 'description': 'Number of participants with sputum eosinophils greater than 3% percent of cells in the sputum'}], 'secondaryOutcomes': [{'measure': 'Number of Participant With Elevated Sputum Neutrophils', 'timeFrame': 'Baseline, +30 minutes', 'description': 'Elevation is defined as sputum neutrophils \\> or = 61% neutrophils = neutrophilic inflammation'}, {'measure': 'Number of Participant With Elevated Exhaled Nitric Oxide (NO) Level', 'timeFrame': '30 min', 'description': 'exhaled NO measurements will be performed according to the American Thoracic Society and European Respiratory Society guidelines. These tests are performed routinely as part of the respiratory evaluation of these patients and are not additional tests added for this study.\n\ngreater than 20 ppb was considered elevated'}, {'measure': 'Number of Participant With Bronchodilator Response', 'timeFrame': 'life time of child (age 6 to present age)', 'description': 'defined as a = or \\> 12% change in FEV1 post bronchodilator'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Congenital Diaphragmatic Hernia', 'Airway Inflammation', 'Asthma', 'Hypersaline', 'Pediatrics'], 'conditions': ['Congenital Diaphragmatic Hernia']}, 'descriptionModule': {'briefSummary': 'We propose to examine Congenital Diaphragmatic Hernia (CDH) patients for evidence of airway inflammation as a first step to characterize the reported bronchodilator responsiveness. Airway biopsy studies are invasive and thus we propose to perform induced sputum studies to document the amount and type of inflammation present. Another ancillary non-invasive measure of airway inflammation that we will use is exhaled nitric oxide (NO). The primary objective of this study is to determine if CDH patients have any evidence of airway inflammation. The hypothesis of this study is that children with CDH do not have evidence of airway inflammation associated with bronchodilator responsiveness. Based on this information, treatment for CDH patients will hopefully be more accurate and appropriate for their specific needs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 6 - 18 years of age at enrolment\n* Clinically stable at enrolment\n* Attending follow-up in the CDH Clinic at SickKids\n\nExclusion Criteria:\n\n* Unable to perform pulmonary function testing\n* Clinically unstable at enrolment\n* Known hypersensitivity to salbutamol'}, 'identificationModule': {'nctId': 'NCT02453750', 'briefTitle': 'Airway Inflammation in Congenital Diaphragmatic Hernia Patients', 'organization': {'class': 'OTHER', 'fullName': 'The Hospital for Sick Children'}, 'officialTitle': 'Investigation of Airway Inflammation in Congenital Diaphragmatic Hernia Patients', 'orgStudyIdInfo': {'id': '1000028032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypersaline and Bronchodilator Response', 'description': 'After the subject has performed post-bronchodilator spirometry, they will inhale 5 mls of 3% hypertonic saline for 7 minutes by nebulizer.', 'interventionNames': ['Drug: Hypersaline', 'Drug: Bronchodilator Response']}], 'interventions': [{'name': 'Hypersaline', 'type': 'DRUG', 'description': "Subject will inhale 5 mls of 3% hypertonic saline for 7 minutes by nebulizer. Sputum production (with cough) will be attempted post inhalation. A maximum of 3 hypertonic saline inhalations will be attempted if inhalation does not generate a productive cough. If sputum induction is not successful and the FEV1 falls \\<10%, the concentration of inhaled hypertonic saline will increase from 3 to 4%. If 5 mls of 4% hypertonic saline inhaled for 7 minutes does not produce a productive cough we will proceed to 5%. If 5 mls of 5% hypertonic saline inhaled for 7 minutes does not produce a productive cough the test is complete and the sample is labelled 'no sputum collected'. If FEV1 falls \\>10%, the previous step will be repeated.", 'armGroupLabels': ['Hypersaline and Bronchodilator Response']}, {'name': 'Bronchodilator Response', 'type': 'DRUG', 'description': 'A bronchodilator (Salbutamol 200 mcg or 2 puffs inhaled via spacer device) will be administered to all subjects in the pulmonary function laboratory. 15 minutes after administration of the bronchodilator spirometry will be repeated. This is performed routinely in CDH clinic and is not an additional test for this study.', 'armGroupLabels': ['Hypersaline and Bronchodilator Response']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Theo Moraes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hospital for Sick Children'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hospital for Sick Children', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Respirologist', 'investigatorFullName': 'Theo Moraes', 'investigatorAffiliation': 'The Hospital for Sick Children'}}}}