Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT01069705
Status:
COMPLETED
Last Update Posted:
2021-06-02
First Post:
2010-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Second Open Label Extension to Bridging Study CTBM100C2303
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011552', 'term': 'Pseudomonas Infections'}, {'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@novartis.com', 'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. 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.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the time of first administration of study drug until study completion (up to 169 days)', 'description': 'AEs were deemed treatment-emergent if the onset date was on or after the date of the first study drug of extension 2 and until study completion of the extension 2.', 'eventGroups': [{'id': 'EG000', 'title': 'Tobramycin Inhalation Powder (TIPnew)', 'description': 'Participants received four capsules of 28 mg TIPnew (112 mg), inhaled twice a day (b.i.d.) in the morning and the evening given in a cycle of 28 days on treatment followed by 28 days off treatment for three consecutive cycles.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 22, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Hypoacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Alcaligenes infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Burkholderia cepacia complex infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Infective pulmonary exacerbation of cystic fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Antibiotic resistant Staphylococcus test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Protein urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}], 'seriousEvents': [{'term': 'Infective pulmonary exacerbation of cystic fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobramycin Inhalation Powder (TIPnew)', 'description': 'Participants received four capsules of 28 mg TIPnew (112 mg), inhaled twice a day (b.i.d.) in the morning and the evening given in a cycle of 28 days on treatment followed by 28 days off treatment for three consecutive cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From time of first administration of study drug until study completion (up to 169 days)', 'description': 'An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who completed their participation in C2303E1, who gave their consent to enter the extension 2 study and who received at least one dose of study drug in the extension 2 study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobramycin Inhalation Powder (TIPnew)', 'description': 'Participants received four capsules of 28 mg TIPnew (112 mg), inhaled twice a day (b.i.d.) in the morning and the evening given in a cycle of 28 days on treatment followed by 28 days off treatment for three consecutive cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From time of consent to 4 weeks after study completion (up to 199 days)', 'description': 'A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who completed their participation in C2303E1, who gave their consent to enter the extension 2 study and who received at least one dose of study drug in the extension 2 study.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With a Decrease of ≥20% in Forced Expiratory Value in One Second (FEV1) Percent (%) Predicted From Pre-dose to 30-minute Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobramycin Inhalation Powder (TIPnew)', 'description': 'Participants received four capsules of 28 mg TIPnew (112 mg), inhaled twice a day (b.i.d.) in the morning and the evening given in a cycle of 28 days on treatment followed by 28 days off treatment for three consecutive cycles.'}], 'classes': [{'title': 'Acute Change from Pre-dose to 30 mins Post-dose Cycle 5 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'Acute Change from Pre-dose to 30 mins Post-dose Cycle 5 (Day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Acute Change from Pre-dose to 30 mins Post-dose Cycle 6 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}]}]}, {'title': 'Acute Change from Pre-dose to 30 mins Post-dose Cycle 6 (Day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000'}]}]}, {'title': 'Acute Change from Pre-dose to 30 mins Post-dose Cycle 7 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'Acute Change from Pre-dose to 30 mins Post-dose Cycle 7 (Day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-dose and post-dose of Day 1 and Day 29 of every Cycle (5, 6, 7)', 'description': 'Airway Reactivity \\>= 20% relative decrease in FEV1% predicted from pre-dose to 30 minutes post-dose. Relative Change = 100 \\* (30 minutes Post-dose - Pre-dose)/Pre-dose assessed by the number and percentage of participants with a decrease of ≥ 20% in FEV1 % predicted from pre-dose to 30 minutes post-dose.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who completed their participation in C2303E1, who gave their consent to enter the extension 2 study and who received at least one dose of study drug in the extension 2 study. Number analyzed is the number of participants with data available at the given timepoint.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Frequency Decrease From Baseline in the Post-baseline Audiology Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobramycin Inhalation Powder (TIPnew)', 'description': 'Participants received four capsules of 28 mg TIPnew (112 mg), inhaled twice a day (b.i.d.) in the morning and the evening given in a cycle of 28 days on treatment followed by 28 days off treatment for three consecutive cycles.'}], 'classes': [{'title': 'Cycle 5: Day 1; >= 10 dB Decrease in 3 Consecutive Frequencies in Either Ear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 5: Day 1; >= 15 dB Decrease in 2 Consecutive Frequencies in Either Ear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 5: Day 1; >= 20 dB Decrease in at least one Frequency in Either Ear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 5: Day 29; >= 10 dB Decrease in 3 Consecutive Frequencies in Either Ear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 5: Day 29; >= 15 dB Decrease in 2 Consecutive Frequencies in Either Ear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 5: Day 29; >= 20 dB Decrease in at least one Frequency in Either Ear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 6: Day 29; >= 10 dB Decrease in 3 Consecutive Frequencies in Either Ear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 6: Day 29; >= 15 dB Decrease in 2 Consecutive Frequencies in Either Ear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 6: Day 29; >= 20 dB Decrease in at least one Frequency in Either Ear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 7: Day 29; ˃= 10 dB Decrease in 3 Consecutive Frequencies in Either Ear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 7: Day 29; >= 15 dB Decrease In 2 Consecutive Frequencies in Either Ear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 7: Day 29; >= 20 dB Decrease in at Least One Frequency in Either Ear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}]}]}, {'title': 'Follow Up: Week 57/Day 57; ˃= 10 dB Decrease in 3 Consecutive Frequencies in Either Ear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}]}]}, {'title': 'Follow Up: Week 57/Day 57; >= 15 dB Decrease In 2 Consecutive Frequencies in Either Ear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Follow Up: Week 57/Day 57; >= 20 dB Decrease in at Least One Frequency in Either Ear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57)', 'description': 'Auditory acuity of participants was measured using a standard dual-channel audiometer at frequencies from 250 to 8000 Hertz, and an audiogram (pure-tone air conduction) and tympanogram were performed by an audiologist. The categories reported includes \\>= 10dB decrease in 3 consecutive frequencies in either ear, \\>= 15dB decrease in 2 consecutive frequencies in either ear, and \\>= 20dB decrease in at least one frequency in either ear', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants included in the safety population with at least one audiology testing. Number analyzed is the number of participants with data available at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Relative Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent Predicted to Each Post-baseline Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobramycin Inhalation Powder (TIPnew)', 'description': 'Participants received four capsules of 28 mg TIPnew (112 mg), inhaled twice a day (b.i.d.) in the morning and the evening given in a cycle of 28 days on treatment followed by 28 days off treatment for three consecutive cycles.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '59.5', 'spread': '16.51', 'groupId': 'OG000'}]}]}, {'title': 'Relative Change from Baseline to Cycle 5 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.4', 'spread': '21.79', 'groupId': 'OG000'}]}]}, {'title': 'Relative Change from Baseline to Cycle 5 (Day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.6', 'spread': '24.49', 'groupId': 'OG000'}]}]}, {'title': 'Relative Change from Baseline to Cycle 6 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.6', 'spread': '19.73', 'groupId': 'OG000'}]}]}, {'title': 'Relative Change from Baseline to Cycle 6 (Day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.9', 'spread': '24.23', 'groupId': 'OG000'}]}]}, {'title': 'Relative Change from Baseline to Cycle 7 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.0', 'spread': '22.44', 'groupId': 'OG000'}]}]}, {'title': 'Relative Change from Baseline to Cycle 7 (Day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.1', 'spread': '26.37', 'groupId': 'OG000'}]}]}, {'title': 'Relative Change from Baseline to Follow -Up (Week 57/Day 57)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.1', 'spread': '25.79', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57)', 'description': "Forced expiratory volume in one second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 % predicted was a normalized value of FEV1 calculated using the Knudsen equation, based upon participant's age, gender and height. Relative change in FEV1 % predicted from baseline to pre-dose day X = ((pre-dose day X FEV1 % predicted - baseline FEV1 % predicted) / baseline FEV1 % predicted) x 100.", 'unitOfMeasure': 'percent change in FEV1 % predicted', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who completed their participation in C2303E1, who gave their consent to enter the extension 2 study and who received at least one dose of study drug in the extension 2 study. Number analyzed is the number of participants with data available at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Relative Change From Baseline of Forced Vital Capacity (FVC) Percent Predicted to Each Post-baseline Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobramycin Inhalation Powder (TIPnew)', 'description': 'Participants received four capsules of 28 mg TIPnew (112 mg), inhaled twice a day (b.i.d.) in the morning and the evening given in a cycle of 28 days on treatment followed by 28 days off treatment for three consecutive cycles.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.0', 'spread': '17.63', 'groupId': 'OG000'}]}]}, {'title': 'Relative Change from Baseline to Cycle 5 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.1', 'spread': '15.60', 'groupId': 'OG000'}]}]}, {'title': 'Relative Change from Baseline to Cycle 5 (Day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.2', 'spread': '17.87', 'groupId': 'OG000'}]}]}, {'title': 'Relative Change from Baseline to Cycle 6 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '16.36', 'groupId': 'OG000'}]}]}, {'title': 'Relative Change from Baseline to Cycle 6 (Day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.2', 'spread': '20.01', 'groupId': 'OG000'}]}]}, {'title': 'Relative Change from Baseline to Cycle 7 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '19.20', 'groupId': 'OG000'}]}]}, {'title': 'Relative Change from Baseline to Cycle 7 (Day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '20.40', 'groupId': 'OG000'}]}]}, {'title': 'Relative Change from Baseline to Follow-up (Week 57/Day 57)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.0', 'spread': '20.37', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57)', 'description': 'Percent Predicted Forced Vital Capacity (FVC%) is the maximal exhaled breath volume following a maximal inhaled breath. Overall change in percent predicted FVC = (observed value)/(predicted value) \\* 100%. A higher value indicates a greater response.', 'unitOfMeasure': 'percent change in FVC % predicted', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who completed their participation in C2303E1, who gave their consent to enter the extension 2 study and who received at least one dose of study drug in the extension 2 study. Number analyzed is the number of participants with data available at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Relative Change From Baseline of Forced Expiratory Flow Rate Over 25 and 75 Percent (FEF25-75%) Predicted to Each Post-baseline Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobramycin Inhalation Powder (TIPnew)', 'description': 'Participants received four capsules of 28 mg TIPnew (112 mg), inhaled twice a day (b.i.d.) in the morning and the evening given in a cycle of 28 days on treatment followed by 28 days off treatment for three consecutive cycles.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36.8', 'spread': '20.30', 'groupId': 'OG000'}]}]}, {'title': 'Relative Change from Baseline to Cycle 5 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '37.7', 'spread': '57.39', 'groupId': 'OG000'}]}]}, {'title': 'Relative Change from Baseline to Cycle 5 (Day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '43.2', 'spread': '67.51', 'groupId': 'OG000'}]}]}, {'title': 'Relative Change from Baseline to Cycle 6 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35.1', 'spread': '66.39', 'groupId': 'OG000'}]}]}, {'title': 'Relative Change from Baseline to Cycle 6 (Day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '34.3', 'spread': '63.53', 'groupId': 'OG000'}]}]}, {'title': 'Relative Change from Baseline to Cycle 7 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44.4', 'spread': '80.91', 'groupId': 'OG000'}]}]}, {'title': 'Relative Change from Baseline to Cycle 7 (Day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36.1', 'spread': '61.75', 'groupId': 'OG000'}]}]}, {'title': 'Relative Change from Baseline to Follow-up (Week 57/Day 57)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35.6', 'spread': '77.34', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57)', 'description': 'Forced Expiratory Flow Rate Over 25 and 75 Percent (FEF25-75%) is the forced expiratory flow from 25% to 75% of the Forced Vital Capacity (FVC). Relative change in FEF25-75% from baseline to pre-dose day X = (pre-dose day X FEF25-75 - baseline FEF25-75) / baseline FEF25-75) • 100.', 'unitOfMeasure': 'percent change in (FEF25-75)% predicted', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who completed their participation in C2303E1, who gave their consent to enter the extension 2 study and who received at least one dose of study drug in the extension 2 study. Number analyzed is the number of participants with data available at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pseudomonas Aeruginosa Sputum Density to Each Post-baseline Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobramycin Inhalation Powder (TIPnew)', 'description': 'Participants received four capsules of 28 mg TIPnew (112 mg), inhaled twice a day (b.i.d.) in the morning and the evening given in a cycle of 28 days on treatment followed by 28 days off treatment for three consecutive cycles.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.4', 'spread': '1.50', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Cycle 5 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '2.82', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Cycle 5 (Day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.7', 'spread': '2.95', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Cycle 6 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'spread': '2.95', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Cycle 6 (Day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.6', 'spread': '2.73', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Cycle 7 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '3.40', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Cycle 7 (Day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '2.92', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Follow-up (Week 57/Day 57)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '3.62', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57)', 'description': 'Pseudomonas Aeruginosa Density refers to overall density, defined as the sum of Biotypes (mucoid, dry and small colony variant). Absolute change was determined using the formula; Change = Post-baseline value- baseline value. Absolute Change in Pseudomonas Aeruginosa Sputum density is measured in log 10 Colony Forming Units per gram (Log 10 CFU/g).', 'unitOfMeasure': 'Log 10 CFU/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who completed their participation in C2303E1, who gave their consent to enter the extension 2 study and who received at least one dose of study drug in the extension 2 study. Number analyzed is the number of participants with data available at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Tobramycin Minimum Inhibitory Concentration (MIC) Values for Pseudomonas Aeruginosa to Each Post-baseline Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobramycin Inhalation Powder (TIPnew)', 'description': 'Participants received four capsules of 28 mg TIPnew (112 mg), inhaled twice a day (b.i.d.) in the morning and the evening given in a cycle of 28 days on treatment followed by 28 days off treatment for three consecutive cycles.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '9.11', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline in Cycle 5 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.4', 'spread': '117.6', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline in Cycle 5 (Day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21.6', 'spread': '92.35', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline in Cycle 6 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '39.3', 'spread': '138.37', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline in Cycle 6 (Day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25.5', 'spread': '94.74', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline in Cycle 7 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.7', 'spread': '22.94', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline in Cycle 7 (Day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.7', 'spread': '115.97', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Follow-up (Week 57/Day 57)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '11.14', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57)', 'description': 'Minimum Inhibitory Concentration (MIC) is defined as the lowest concentration of an antimicrobial agent required to inhibit the visible growth of a microorganism after overnight incubation.', 'unitOfMeasure': 'microgram/millilitre', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who completed their participation in C2303E1, who gave their consent to enter the extension 2 study and who received at least one dose of study drug in the extension 2 study. Number analyzed is the number of participants with data available at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Used New Antipseudomonal Antibiotic During Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobramycin Inhalation Powder (TIPnew)', 'description': 'Participants received four capsules of 28 mg TIPnew (112 mg), inhaled twice a day (b.i.d.) in the morning and the evening given in a cycle of 28 days on treatment followed by 28 days off treatment for three consecutive cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Cycles 5, 6, 7 (Days 1, 29)', 'description': 'The rate of anti-pseudomonal antibiotics use were determined from the collection of concomitant medication during the study Treatment period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who completed their participation in C2303E1, who gave their consent to enter the extension 2 study and who received at least one dose of study drug in the extension 2 study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Hospitalization Due to Respiratory Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobramycin Inhalation Powder (TIPnew)', 'description': 'Participants received four capsules of 28 mg TIPnew (112 mg), inhaled twice a day (b.i.d.) in the morning and the evening given in a cycle of 28 days on treatment followed by 28 days off treatment for three consecutive cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From time of consent to 4 weeks after study completion (up to 199 days)', 'description': 'A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who completed their participation in C2303E1, who gave their consent to enter the extension 2 study and who received at least one dose of study drug in the extension 2 study. Number analyzed is the number of participants with data available at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Number of Days of Hospitalization Due to Respiratory Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tobramycin Inhalation Powder (TIPnew)', 'description': 'Participants received four capsules of 28 mg TIPnew (112 mg), inhaled twice a day (b.i.d.) in the morning and the evening given in a cycle of 28 days on treatment followed by 28 days off treatment for three consecutive cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.5', 'spread': '2.12', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From time of consent to 4 weeks after study completion (up to 199 days)', 'description': 'The average number of days patients were hospitalized due to respiratory events during the study.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who completed their participation in C2303E1, who gave their consent to enter the extension 2 study and who received at least one dose of study drug in the extension 2 study. Number analyzed is the number of participants with data available at the given timepoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tobramycin Inhalation Powder (TIPnew)', 'description': 'Participants received four capsules of 28 mg TIPnew (112 mg), inhaled twice a day (b.i.d.) in the morning and the evening given in a cycle of 28 days on treatment followed by 28 days off treatment for three consecutive cycles.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'The study was conducted at 14 centres in 8 countries from 12 February 2010 to 19 March 2012.', 'preAssignmentDetails': 'This study enrolled 49 Participants with Cystic Fibrosis who completed participation in the study CTBM100C2303E1 (NCT00982930).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Tobramycin Inhalation Powder (TIPnew)', 'description': 'Participants received four capsules of 28 mg TIPnew (112 mg), inhaled twice a day (b.i.d.) in the morning and the evening given in a cycle of 28 days on treatment followed by 28 days off treatment for three consecutive cycles.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '13.3', 'spread': '4.31', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population included all participants who completed their participation in C2303E1, who gave their consent to enter the extension 2 study and who received at least one dose of study drug in the extension 2 study.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2012-03-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-06', 'studyFirstSubmitDate': '2010-02-15', 'resultsFirstSubmitDate': '2021-05-06', 'studyFirstSubmitQcDate': '2010-02-16', 'lastUpdatePostDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-06', 'studyFirstPostDateStruct': {'date': '2010-02-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-03-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'From time of first administration of study drug until study completion (up to 169 days)', 'description': 'An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug.'}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs)', 'timeFrame': 'From time of consent to 4 weeks after study completion (up to 199 days)', 'description': 'A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes.'}, {'measure': 'Percentage of Participants With a Decrease of ≥20% in Forced Expiratory Value in One Second (FEV1) Percent (%) Predicted From Pre-dose to 30-minute Post-dose', 'timeFrame': 'Pre-dose and post-dose of Day 1 and Day 29 of every Cycle (5, 6, 7)', 'description': 'Airway Reactivity \\>= 20% relative decrease in FEV1% predicted from pre-dose to 30 minutes post-dose. Relative Change = 100 \\* (30 minutes Post-dose - Pre-dose)/Pre-dose assessed by the number and percentage of participants with a decrease of ≥ 20% in FEV1 % predicted from pre-dose to 30 minutes post-dose.'}, {'measure': 'Percentage of Participants With Frequency Decrease From Baseline in the Post-baseline Audiology Tests', 'timeFrame': 'Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57)', 'description': 'Auditory acuity of participants was measured using a standard dual-channel audiometer at frequencies from 250 to 8000 Hertz, and an audiogram (pure-tone air conduction) and tympanogram were performed by an audiologist. The categories reported includes \\>= 10dB decrease in 3 consecutive frequencies in either ear, \\>= 15dB decrease in 2 consecutive frequencies in either ear, and \\>= 20dB decrease in at least one frequency in either ear'}], 'secondaryOutcomes': [{'measure': 'Relative Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent Predicted to Each Post-baseline Visit', 'timeFrame': 'Baseline, Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57)', 'description': "Forced expiratory volume in one second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 % predicted was a normalized value of FEV1 calculated using the Knudsen equation, based upon participant's age, gender and height. Relative change in FEV1 % predicted from baseline to pre-dose day X = ((pre-dose day X FEV1 % predicted - baseline FEV1 % predicted) / baseline FEV1 % predicted) x 100."}, {'measure': 'Relative Change From Baseline of Forced Vital Capacity (FVC) Percent Predicted to Each Post-baseline Visit', 'timeFrame': 'Baseline, Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57)', 'description': 'Percent Predicted Forced Vital Capacity (FVC%) is the maximal exhaled breath volume following a maximal inhaled breath. Overall change in percent predicted FVC = (observed value)/(predicted value) \\* 100%. A higher value indicates a greater response.'}, {'measure': 'Relative Change From Baseline of Forced Expiratory Flow Rate Over 25 and 75 Percent (FEF25-75%) Predicted to Each Post-baseline Visit', 'timeFrame': 'Baseline, Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57)', 'description': 'Forced Expiratory Flow Rate Over 25 and 75 Percent (FEF25-75%) is the forced expiratory flow from 25% to 75% of the Forced Vital Capacity (FVC). Relative change in FEF25-75% from baseline to pre-dose day X = (pre-dose day X FEF25-75 - baseline FEF25-75) / baseline FEF25-75) • 100.'}, {'measure': 'Change From Baseline in Pseudomonas Aeruginosa Sputum Density to Each Post-baseline Visit', 'timeFrame': 'Baseline, Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57)', 'description': 'Pseudomonas Aeruginosa Density refers to overall density, defined as the sum of Biotypes (mucoid, dry and small colony variant). Absolute change was determined using the formula; Change = Post-baseline value- baseline value. Absolute Change in Pseudomonas Aeruginosa Sputum density is measured in log 10 Colony Forming Units per gram (Log 10 CFU/g).'}, {'measure': 'Change From Baseline in Tobramycin Minimum Inhibitory Concentration (MIC) Values for Pseudomonas Aeruginosa to Each Post-baseline Visit', 'timeFrame': 'Baseline, Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57)', 'description': 'Minimum Inhibitory Concentration (MIC) is defined as the lowest concentration of an antimicrobial agent required to inhibit the visible growth of a microorganism after overnight incubation.'}, {'measure': 'Number of Participants Who Used New Antipseudomonal Antibiotic During Treatment Period', 'timeFrame': 'Baseline, Cycles 5, 6, 7 (Days 1, 29)', 'description': 'The rate of anti-pseudomonal antibiotics use were determined from the collection of concomitant medication during the study Treatment period.'}, {'measure': 'Percentage of Participants With Hospitalization Due to Respiratory Serious Adverse Events (SAEs)', 'timeFrame': 'From time of consent to 4 weeks after study completion (up to 199 days)', 'description': 'A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes.'}, {'measure': 'Number of Days of Hospitalization Due to Respiratory Serious Adverse Events (SAEs)', 'timeFrame': 'From time of consent to 4 weeks after study completion (up to 199 days)', 'description': 'The average number of days patients were hospitalized due to respiratory events during the study.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tobramycin Inhalation Powder', 'Cystic fibrosis', 'Lung diseases', 'Anti-Bacterial Agents', 'Treatment of pulmonary infections with P. aeruginosa in cystic fibrosis participants'], 'conditions': ['Pulmonary Infections', 'Pseudomonas Aeruginosa']}, 'referencesModule': {'references': [{'pmid': '26709158', 'type': 'RESULT', 'citation': 'Konstan MW, Flume PA, Galeva I, Wan R, Debonnett LM, Maykut RJ, Angyalosi G. One-year safety and efficacy of tobramycin powder for inhalation in patients with cystic fibrosis. Pediatr Pulmonol. 2016 Apr;51(4):372-8. doi: 10.1002/ppul.23358. Epub 2015 Dec 27.'}]}, 'descriptionModule': {'briefSummary': 'This was an open-label, single arm (uncontrolled) study in participants suffering from cystic fibrosis, who have completed their study participation in CTBM100C2303 and extension study one CTBM100C2303E1 (all visits), who were proven infected with Pseudomonas aeruginosa at enrollment into CTBM100C2303.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Completed all visits in study CTBM100C2303 and CTBM100C2303E1, and visit 11 of study CTBM100C2303E1 took place not more than 5 days before enrollment into this study.\n* Confirmed diagnosis of cystic fibrosis participants with P. aeruginosa infection.\n* Forced Expiratory Volume in one second (FEV1) at screening (at start of study CTBM100C2303) must be between 25% and 80% of normal predicted values.\n\nExclusion Criteria:\n\n* Any use of inhaled anti-pseudomonal antibiotics between the termination of the trial CTMB100C2303E1 and the enrollment into this study.\n* Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.'}, 'identificationModule': {'nctId': 'NCT01069705', 'briefTitle': 'Second Open Label Extension to Bridging Study CTBM100C2303', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder After Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who Successfully Completed Participation in Study CTBM100C2303E1', 'orgStudyIdInfo': {'id': 'CTBM100C2303E2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tobramycin Inhalation Powder (TIPnew)', 'description': 'Participants received four capsules of 28 mg TIPnew (112 mg), inhaled twice a day (b.i.d.) in the morning and the evening given in a cycle of 28 days on treatment followed by 28 days off treatment for three consecutive cycles.', 'interventionNames': ['Drug: Tobramycin inhalation powder']}], 'interventions': [{'name': 'Tobramycin inhalation powder', 'type': 'DRUG', 'description': 'Tobramycin dry powder for inhalation in capsules administered by the T-326 inhaler.', 'armGroupLabels': ['Tobramycin Inhalation Powder (TIPnew)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pleven', 'country': 'Bulgaria', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Varna', 'country': 'Bulgaria', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.21912, 'lon': 27.91024}}, {'city': 'Tallinn', 'country': 'Estonia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'city': 'Tartu', 'country': 'Estonia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}, {'city': 'Riga', 'country': 'Latvia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Timișoara', 'country': 'Romania', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}, {'city': "Kazan'", 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Samara', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'city': 'Yaroslavl', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}, {'city': 'Durban', 'country': 'South Africa', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}