Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2026-02-21 @ 8:27 AM
Study NCT ID:
NCT02631603
Status:
TERMINATED
Last Update Posted:
2024-12-18
First Post:
2015-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Stop Exogenous Allergic Alveolitis (EAA) in Childhood
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000542', 'term': 'Alveolitis, Extrinsic Allergic'}], 'ancestors': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D008775', 'term': 'Methylprednisolone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'matthias.griese@med.uni-muenchen.de', 'phone': '+498944000', 'title': 'Prof. Dr. med. Matthias Griese', 'phoneExt': '57870', 'organization': 'LMU/ Haunersches Kinderspital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The major limitation of this trial was its premature closure and the small number of patients included. This was due to several reasons: the study design was developed as work package within a limited research project. The anticipated enrolment was lower than expected. There was a lack of resources to carry on the clinical trial for the many years in view of the much lower incidences of this rare conditions than calculated before on available data.'}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'The adverse events were collected during the study visits or during the telephone visits.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Capsules of placebo will be taken for 3 months.\n\nPlacebo: Administer Placebo as anti-inflammatory', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Prednisolone', 'description': 'Oral prednisolone, anticipated dose:\n\nfirst month 0.5 mg/kg bw/d, second month 0.25 mg/kg bw/d, and third month 0.125 mg/kg bw/d in a single morning dose.\n\nIndividual capsules will be prepared using rounded dose.\n\nPrednisolone: Administer Prednisolone as anti-inflammatory', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fever, headache, haematome, tiredness, hypertension', 'notes': 'Besides the occurance of adverse events and their frequency also the affected organ system was collected in the study data.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctivitis', 'notes': 'Besides the occurance of adverse events and their frequency also the affected organ system was collected in the study data.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory tract infection, candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cushing habitus, hair growth, weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Forced Vital Capacity (FVC).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Prednisolone 1', 'description': 'Oral prednisolone, anticipated dose:\n\nfirst month 0.5 mg/kg bw/d, second month 0.25 mg/kg bw/d, and third month 0.125 mg/kg bw/d in a single morning dose.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsules of placebo will be taken for 3 months'}, {'id': 'OG002', 'title': 'Prednisolone 2', 'description': 'Oral prednisolone, anticipated dose:\n\nfirst month 0.5 mg/kg bw/d, second month 0.25 mg/kg bw/d, and third month 0.125 mg/kg bw/d in a single morning dose.'}, {'id': 'OG003', 'title': 'Prednisolone 3', 'description': 'Oral prednisolone, anticipated dose:\n\nfirst month 0.5 mg/kg bw/d, second month 0.25 mg/kg bw/d, and third month 0.125 mg/kg bw/d in a single morning dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'The relative change from baseline through month 6 compared to change from placebo of FVC.', 'unitOfMeasure': '% predicted', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Forced Vital Capacity (FVC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Prednisolone 1', 'description': 'Oral prednisolone, anticipated dose:\n\nfirst month 0.5 mg/kg bw/d, second month 0.25 mg/kg bw/d, and third month 0.125 mg/kg bw/d in a single morning dose.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsules of placebo will be taken for 3 months.'}, {'id': 'OG002', 'title': 'Prednisolone 2', 'description': 'Oral prednisolone, anticipated dose:\n\nfirst month 0.5 mg/kg bw/d, second month 0.25 mg/kg bw/d, and third month 0.125 mg/kg bw/d in a single morning dose.'}, {'id': 'OG003', 'title': 'Prednisolone 3', 'description': 'Oral prednisolone, anticipated dose:\n\nfirst month 0.5 mg/kg bw/d, second month 0.25 mg/kg bw/d, and third month 0.125 mg/kg bw/d in a single morning dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '114', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'FVC measured in accordance to standarized protocol.', 'unitOfMeasure': '% predicted', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Capsules of placebo will be taken for 3 months.\n\nPlacebo: Administer Placebo as anti-inflammatory'}, {'id': 'FG001', 'title': 'Prednisolone', 'description': 'Oral prednisolone, anticipated dose:\n\nfirst month 0.5 mg/kg bw/d, second month 0.25 mg/kg bw/d, and third month 0.125 mg/kg bw/d in a single morning dose.\n\nIndividual capsules will be prepared using rounded dose.\n\nPrednisolone: Administer Prednisolone as anti-inflammatory'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Originally, it was planned to screen 60 subjects to include approximately 40 patients. From January 2015 to July 2016 due to difficulties in funding only 4 children were included in the trial. All met inclusion criteria, were randomized, and completed the trial.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Prednisolone 1', 'description': 'Oral prednisolone, anticipated dose:\n\nfirst month after steroid pulse 0.5 mg/kg bw/d, second month 0.25 mg/kg bw/d, and third month 0.125 mg/kg bw/d in a single morning dose.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Capsules of placebo will be taken for 3 months.'}, {'id': 'BG002', 'title': 'Prednisolone 2', 'description': 'Oral prednisolone, anticipated dose:\n\nfirst month after steroid pulse 0.5 mg/kg bw/d, second month 0.25 mg/kg bw/d, and third month 0.125 mg/kg bw/d in a single morning dose.'}, {'id': 'BG003', 'title': 'Prednisolone 3', 'description': 'Oral prednisolone, anticipated dose:\n\nfirst month after steroid pulse 0.5 mg/kg bw/d, second month 0.25 mg/kg bw/d, and third month 0.125 mg/kg bw/d in a single morning dose.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'groupId': 'BG000'}, {'value': '6.6', 'groupId': 'BG001'}, {'value': '10.6', 'groupId': 'BG002'}, {'value': '12.9', 'groupId': 'BG003'}, {'value': '9.6', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'Patients between 3 to 18 years', 'unitOfMeasure': 'years'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'O2 saturation at rest', 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '97', 'groupId': 'BG003'}, {'value': '96.3', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': '%'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-12-11', 'size': 705764, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-04-27T07:51', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'After several years of recruitment only 4 patients were included. Study timelines for study completition too long. Decided to terminate trial.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-13', 'studyFirstSubmitDate': '2015-11-29', 'resultsFirstSubmitDate': '2022-09-21', 'studyFirstSubmitQcDate': '2015-12-15', 'lastUpdatePostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-13', 'studyFirstPostDateStruct': {'date': '2015-12-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Forced Vital Capacity (FVC).', 'timeFrame': '6 months', 'description': 'The relative change from baseline through month 6 compared to change from placebo of FVC.'}], 'secondaryOutcomes': [{'measure': 'Forced Vital Capacity (FVC)', 'timeFrame': '3 months', 'description': 'FVC measured in accordance to standarized protocol.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Children', 'Birds', 'Moulds'], 'conditions': ['Hypersensitivity Pneumonitis', 'Exogenous Allergic Alveolitis']}, 'referencesModule': {'references': [{'pmid': '34048641', 'type': 'RESULT', 'citation': 'Griese M, Stehling F, Schwerk N, Rosewich M, Jerkic PS, Rock H, Ruckes C, Kronfeld K, Sebah D, Wetzke M, Seidl E. Hypersensitivity pneumonitis: Lessons from a randomized controlled trial in children. Pediatr Pulmonol. 2021 Aug;56(8):2627-2633. doi: 10.1002/ppul.25513. Epub 2021 May 28.'}]}, 'descriptionModule': {'briefSummary': 'Stop exogenous allergic alveolitis (EAA) or hypersensitivity pneumonitis in childhood: healthy into adulthood - a randomized, double-blind, placebo-controlled, parallel-group study to evaluate prednisolone treatment and course of disease.\n\nThe hypothesis of the study is that the treatment with placebo will not be inferior in terms of Forced Vital Capacity (FVC) improvement than treatment with systemic steroids after 6 months treatment.', 'detailedDescription': 'After an initial steroid pulse given to all patients, patients will be allocated to the two treatments, i.e., oral prednisolone and Placebo.\n\nExperimental intervention: Placebo Control intervention: Prednisolone Duration of intervention per patient: 3 months Follow-up per patient: 3 months\n\nPrimary Objective:\n\nTo evaluate outcome of EAA at 6 months and compare the medium term treatment with systemic steroids or placebo.\n\nSecondary Objectives:\n\nTo evaluate the completeness and knowledge of standardized and pedantic allergen elimination in families with a child with EAA.\n\nTo evaluate the treatment of EAA with systemic steroids compared to placebo at 3 months.\n\nTo evaluate the safety of the treatment of EAA with outpatient usage of systemic steroids compared to Placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Newly or previously diagnosed but not appropriately treated EAA in children, adolescents and young adults, aged between 3 and 25 years. The diagnosis of EAA must be confirmed by independent review of the findings by an expert panel and must be based on the presence of at least 4 of the following findings:\n\n * History of appropriate allergen exposure\n * Restrictive lung function (FVC \\< 80% predicted for age and FVC/FEV1 \\< 1) testing, if appropriate for age (usually \\> 5 y)\n * Positive serum precipitins for bird/fungus exposed to (other allergens have rarely, if every been demonstrated in children)\n * Lymphocytosis in BAL (\\> 20% of cells are lymphocytes)\n * HRCT showing the characteristic nodular, linear or reticular opacities, and ground glass pattern with increased attenuation.\n * Lung biopsy demonstrating lymphocytic alveolitis, bronchiolitis, and non-caseating histiocytic granulomatas.\n * Controlled allergen exposure followed by characteristic reaction, including fever, coughing, restriction on lung function, hypoxemia/desaturation at rest or with exercise\n2. Unchanged inhaled steroids if on; if off, no plans to introduce them in the following 6 months\n3. Agreement to home visit by independent study physician\n\nExclusion Criteria:\n\n1. Contraindication for usage systemic steroids\n2. Critically ill patients needing respiratory support\n3. Non-compliance with medical treatments and interventions\n4. Women with childbearing potential and not practicing a medically accepted contraception during the trial and a positive pregnancy test (serum or urine) before and at the end of the trial. Reliable contraception are systematic contraceptives (oral, implant, injection) and diaphragm or condoms with spermicide.\n5. Pregnancy and lactation.\n6. Participation in another trial for EAA during the last 4 weeks or not beyond the time of 4 half-lives of the medication used. In the unlikely event a subject is already in another clinical study but not for EAA, that study must be stopped and the subject may be treated according to this protocol; a latency time between the two studies does not appear reasonable, as acute intervention is necessary for EAA. Treatment may be best done in the frame work of this protocol.'}, 'identificationModule': {'nctId': 'NCT02631603', 'acronym': 'chILD-EU_EAA', 'briefTitle': 'Stop Exogenous Allergic Alveolitis (EAA) in Childhood', 'organization': {'class': 'OTHER', 'fullName': 'Ludwig-Maximilians - University of Munich'}, 'officialTitle': 'Stop Exogenous Allergic Alveolitis (EAA) in Childhood: Healthy Into Adulthood - A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate Prednisolone Treatment and Course of Disease', 'orgStudyIdInfo': {'id': 'StopEAA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': 'Capsules of placebo will be taken for 3 months, same schedule as verum.', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prednisolone', 'description': 'Oral prednisolone, anticipated dose:\n\nfirst month 0.5 mg/kg bw/d, second month 0.25 mg/kg bw/d, and third month 0.125 mg/kg bw/d in a single morning dose.\n\nIndividual capsules will be prepared using rounded dose.', 'interventionNames': ['Drug: Prednisolone']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['no other name'], 'description': 'Administer Placebo as anti-inflammatory', 'armGroupLabels': ['Placebo']}, {'name': 'Prednisolone', 'type': 'DRUG', 'otherNames': ['Decortin H'], 'description': 'Administer Prednisolone as anti-inflammatory', 'armGroupLabels': ['Prednisolone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80337', 'city': 'München', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Klinikum der Universität München, Haunersches Kinderspital', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}, {'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Universitätsklinikum Frankfurt, Pneumologie, Allergologie, Mukoviszidose', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '35385', 'city': 'Giessen', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Justus-Liebig-Universität, Allgemeine Pädiatrie u. Neonatologie', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'zip': '30625', 'city': 'Hanover', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '44791', 'city': 'Bochum', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum im St. Josef-Hospital', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '45122', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Uniklinikum Essen, Pädiatrische Pneumologie', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '04103', 'city': 'Leipzig', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Klinik u. Poliklinik für Kinder- u. Jugendmedizin der Universität Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'overallOfficials': [{'name': 'Matthias Griese, Prof., MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pediatric Pneumology, Ludwig-Maximilians-University Munich'}, {'name': 'Meike Hengst, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pediatric Pneumology, Ludwig-Maximilians University Munich'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Equivalent to product information sheet'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Matthias Griese', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med.', 'investigatorFullName': 'Matthias Griese', 'investigatorAffiliation': 'Ludwig-Maximilians - University of Munich'}}}}