Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-02-21 @ 11:36 PM
Study NCT ID:
NCT01082367
Status:
COMPLETED
Last Update Posted:
2016-07-15
First Post:
2010-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years
Sponsor:
Organization:
Raw JSON
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Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'DB TOBI', 'description': 'DB TOBI', 'otherNumAtRisk': 32, 'otherNumAffected': 12, 'seriousNumAtRisk': 32, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'DB Placebo', 'description': 'DB Placebo', 'otherNumAtRisk': 38, 'otherNumAffected': 18, 'seriousNumAtRisk': 38, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'OL TOBI (Core)', 'description': 'OL TOBI (core)', 'otherNumAtRisk': 22, 'otherNumAffected': 10, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Off-treatment (Core)', 'description': 'Off-treatment (core)', 'otherNumAtRisk': 50, 'otherNumAffected': 13, 'seriousNumAtRisk': 50, 'seriousNumAffected': 2}, 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'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasal dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 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'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rash generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Glucose-6-phosphate dehydrogenase deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bacterial disease carrier', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Croup infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Infective pulmonary exacerbation of cystic fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lower respiratory tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pseudomonas infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Stridor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants P Aeruginosa-free After Completion of the First Treatment Cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TOBI (Tobramycin Inhaled Solution)/Placebo', 'description': 'Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.'}, {'id': 'OG001', 'title': 'Placebo/TOBI', 'description': 'Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '84.6', 'groupId': 'OG000'}, {'value': '24.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.55', 'ciLowerLimit': '4.67', 'ciUpperLimit': '99.52', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 29', 'description': 'Sputum/throat swab cultures were assessed.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT): The ITT included all randomized participants who received at least dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Free From P. Aeruginosa 28 Days After Termination of the Second Treatment Cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TOBI (Tobramycin Inhaled Solution)/Placebo', 'description': 'Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.'}, {'id': 'OG001', 'title': 'Placebo/TOBI', 'description': 'Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '92.3', 'groupId': 'OG000'}, {'value': '83.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 91', 'description': 'Sputum/throat swab cultures were assessed.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Cross-over participants from the ITT population were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants P Aeruginosa-free at Termination of the Double Blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TOBI (Tobramycin Inhaled Solution)/Placebo', 'description': 'Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.'}, {'id': 'OG001', 'title': 'Placebo/TOBI', 'description': 'Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '76.0', 'groupId': 'OG000'}, {'value': '47.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 91', 'description': 'Sputum/throat swab cultures were assessed.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the ITT population, who were tested for microbiology, were included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TOBI (Tobramycin Inhaled Solution)/Placebo', 'description': 'Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.'}, {'id': 'FG001', 'title': 'Placebo/TOBI', 'description': 'Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.'}], 'periods': [{'title': 'Double-blind Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'Stage 1:1st Treatment (tx) Cycle', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'comment': '1 participant discontinued after cycle 1 due to an SAE', 'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'Stage 2:no tx', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Entered OL TOBI', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'P.A-free,Day 29 w/ no Cross-over', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Stage 3: Cross-over (co) tx', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Stage 4:no tx for Patients Not in co', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Follow-up (F-U) Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Treated in F-U', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Abnormal lab values', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were randomized 1:1 to TOBI or placebo. After 1 treatment cycle, participants who were P.a positive entered an OL phase. Participants who were P.a negative entered cross-over treatment.', 'preAssignmentDetails': 'The cross-over was optional. At the end of the cross-over or OL phase, participants who were P.a positive terminated the study. P.a negative participants entered follow-up.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'TOBI (Tobramycin Inhaled Solution)/Placebo', 'description': 'Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.'}, {'id': 'BG001', 'title': 'Placebo/TOBI', 'description': 'Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '1.96', 'groupId': 'BG000'}, {'value': '2.7', 'spread': '1.93', 'groupId': 'BG001'}, {'value': '2.8', 'spread': '1.93', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-06', 'studyFirstSubmitDate': '2010-03-05', 'resultsFirstSubmitDate': '2015-12-22', 'studyFirstSubmitQcDate': '2010-03-05', 'lastUpdatePostDateStruct': {'date': '2016-07-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-03-24', 'studyFirstPostDateStruct': {'date': '2010-03-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants P Aeruginosa-free After Completion of the First Treatment Cycle', 'timeFrame': 'Day 29', 'description': 'Sputum/throat swab cultures were assessed.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Free From P. Aeruginosa 28 Days After Termination of the Second Treatment Cycle', 'timeFrame': 'Day 91', 'description': 'Sputum/throat swab cultures were assessed.'}, {'measure': 'Percentage of Participants P Aeruginosa-free at Termination of the Double Blind Period', 'timeFrame': 'Day 91', 'description': 'Sputum/throat swab cultures were assessed.'}]}, 'conditionsModule': {'keywords': ['Tobramycin Inhalation solution', 'Cystic fibrosis', 'Lung disease', 'anti-bacterial agents'], 'conditions': ['Treatment of Early Pulmonary Infections With P. Aeruginosa in Cystic Fibrosis Patients']}, 'referencesModule': {'references': [{'pmid': '29685813', 'type': 'DERIVED', 'citation': 'Ratjen F, Moeller A, McKinney ML, Asherova I, Alon N, Maykut R, Angyalosi G; EARLY study group. Eradication of early P. aeruginosa infection in children <7 years of age with cystic fibrosis: The early study. J Cyst Fibros. 2019 Jan;18(1):78-85. doi: 10.1016/j.jcf.2018.04.002. Epub 2018 Apr 21.'}]}, 'descriptionModule': {'briefSummary': 'This study investigated the efficacy of inhaled TOBI treatment for early infections of P. aeruginosa in paediatric patients with cystic fibrosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of cystic fibrosis\n* Early lower respiratory tract infection with P. aeruginosa,\n\nExclusion Criteria:\n\n* Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.\n* Administration of loop diuretics within 7 days prior to study drug administration.\n* Other protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01082367', 'acronym': 'EARLY', 'briefTitle': 'Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. Aeruginosa in Cystic Fibrosis Subjects Aged From 3 Months to Less Than 7 Years', 'orgStudyIdInfo': {'id': 'CTBM100C2304'}, 'secondaryIdInfos': [{'id': '2009-016590-15', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TOBI (tobramycin inhaled solution)/Placebo', 'description': 'Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle).', 'interventionNames': ['Drug: TOBI', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo/TOBI', 'description': 'Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle).', 'interventionNames': ['Drug: TOBI', 'Drug: Placebo']}], 'interventions': [{'name': 'TOBI', 'type': 'DRUG', 'description': 'TOBI (tobramycin inhaled solution)', 'armGroupLabels': ['Placebo/TOBI', 'TOBI (tobramycin inhaled solution)/Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo/TOBI', 'TOBI (tobramycin inhaled solution)/Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H3T1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '21131', 'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '75019', 'city': 'Paris', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '265 00', 'city': 'Pátrai', 'state': 'Greece', 'country': 'Greece', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.2462, 'lon': 21.73508}}, {'zip': '546 29', 'city': 'Thessaloniki', 'state': 'GR', 'country': 'Greece', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '546 42', 'city': 'Thessaloniki', 'state': 'GR', 'country': 'Greece', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '4032', 'city': 'Debrecen', 'state': 'Hungary', 'country': 'Hungary', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '7400', 'city': 'Kaposvár', 'state': 'Hungary', 'country': 'Hungary', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 46.36667, 'lon': 17.8}}, {'zip': '6725', 'city': 'Szeged', 'state': 'Hungary', 'country': 'Hungary', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'zip': '4043', 'city': 'Debrecen', 'country': 'Hungary', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '20122', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20395', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '420012', 'city': "Kazan'", 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'zip': '394036', 'city': 'Voronezh', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.66833, 'lon': 39.19204}}, {'zip': '150003', 'city': 'Yaroslavl', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}, {'zip': '8032', 'city': 'Zurich', 'state': 'Switzerland', 'country': 'Switzerland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}