Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2026-01-01 @ 1:03 PM
Study NCT ID:
NCT00918957
Status:
COMPLETED
Last Update Posted:
2012-10-03
First Post:
2009-06-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Tobramycin Inhalation Powder From a Modified Manufacturing Process Versus Placebo
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'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': {'phone': '862-778-8300', 'title': 'Clinical Disclosure Office', '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 or disclosure of trial results in their entirety.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'TIP (Tobramycin Inhalation Powder)', 'description': 'Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.', 'otherNumAtRisk': 30, 'otherNumAffected': 4, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).', 'otherNumAtRisk': 32, 'otherNumAffected': 6, 'seriousNumAtRisk': 32, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Hypoacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.X'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Relative Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent Predicted to End of Dosing (Day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TIP (Tobramycin Inhalation Powder)', 'description': 'Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).'}], 'classes': [{'title': 'Participants analyzed: ITT Population (31, 28)', 'categories': [{'measurements': [{'value': '8.2', 'spread': '2.93', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '14.1'}, {'value': '2.3', 'spread': '3.13', 'groupId': 'OG001', 'lowerLimit': '-4.0', 'upperLimit': '8.6'}]}]}, {'title': 'Parts. analyzed: Modified ITT Pop (27, 27)', 'categories': [{'measurements': [{'value': '9.7', 'spread': '3.30', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '16.3'}, {'value': '2.5', 'spread': '3.30', 'groupId': 'OG001', 'lowerLimit': '-4.1', 'upperLimit': '9.2'}]}]}, {'title': 'Parts analyzed: Observed Cases in ITT Pop (25, 27)', 'categories': [{'measurements': [{'value': '10.3', 'spread': '3.42', 'groupId': 'OG000', 'lowerLimit': '3.4', 'upperLimit': '17.2'}, {'value': '2.4', 'spread': '3.35', 'groupId': 'OG001', 'lowerLimit': '-4.3', 'upperLimit': '9.2'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 29', 'description': 'Relative change in percentage predicted FEV1 in the Intent-to-treat (ITT), modified ITT (mITT) and Observed cases in the ITT populations were calculated from an adjusted analysis ANOVA model.\n\nITT Patients with missing or unacceptable Day 29 spirometry measurements had their primary endpoint data imputed with zero.\n\nBSL = Baseline, defined as the latest measurement prior to the first dosing of study medication\n\n\\- Relative change = 100 \\* (value - baseline) / baseline There were 3 patients who had no screening nor baseline values (due to inadequate spirometry) and so were excluded from all change from baseline analyses.', 'unitOfMeasure': 'change in percentage', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT: All randomized patients (pts) received at least one dose of study drug. Missing or unacceptable Day 29 spirometry test -change from baseline FEV1 % predicted imputed using last available post-baseline value or 0. mITT: Pts with unacceptable FEV1 measurements excluded. Observed cases: Pts with missing or unacceptable FEV1 measurements excluded.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Forced Vital Capacity (FVC) Percent Predicted to End of Dosing (Day 29) and to the End of Off-cycle Period (Day 57)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TIP (Tobramycin Inhalation Powder)', 'description': 'Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).'}], 'classes': [{'title': 'Number of participants analyzed (31, 28): Baseline', 'categories': [{'measurements': [{'value': '73.3', 'spread': '19.19', 'groupId': 'OG000'}, {'value': '76.9', 'spread': '15.16', 'groupId': 'OG001'}]}]}, {'title': 'Number of participants analyzed (25, 27): Day 29', 'categories': [{'measurements': [{'value': '7.2', 'spread': '9.94', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '10.4'}, {'value': '1.6', 'spread': '14.74', 'groupId': 'OG001', 'lowerLimit': '-3.4', 'upperLimit': '6.6'}]}]}, {'title': 'Number of participants analyzed (28, 23): Day 57', 'categories': [{'measurements': [{'value': '5.2', 'spread': '16.99', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '15.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 29, Day 57', 'description': 'Results of statistical analysis were calculated from an ANOVA model. Baseline is defined as the latest measurement prior to the first dosing of study medication.\n\nResponse (percentage change) = treatment + Screening FEV1 percentage predicted (\\<50 and \\>=50) + age (\\<13 and \\>=13) + error', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Forced Expiratory Flow Rate Over 25 and 75 Percent. (FEF25-75%) Predicted to End of Dosing (Day 29) and End of Off-cycle Period (Day 57)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TIP (Tobramycin Inhalation Powder)', 'description': 'Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).'}], 'classes': [{'title': 'Number of participants analyzed (31, 28): Baseline', 'categories': [{'measurements': [{'value': '36.2', 'spread': '20.15', 'groupId': 'OG000'}, {'value': '35.9', 'spread': '20.67', 'groupId': 'OG001'}]}]}, {'title': 'Number of participants analyzed (25, 27): Day 29', 'categories': [{'measurements': [{'value': '21.00', 'spread': '36.55', 'groupId': 'OG000', 'lowerLimit': '4.7', 'upperLimit': '28.3'}, {'value': '7.8', 'spread': '29.65', 'groupId': 'OG001', 'lowerLimit': '-5.9', 'upperLimit': '19.3'}]}]}, {'title': 'Number of participants analyzed (28, 23): Day 57', 'categories': [{'measurements': [{'value': '23.9', 'spread': '35.57', 'groupId': 'OG000'}, {'value': '17.7', 'spread': '37.40', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 29, Day 57', 'description': 'FEF25-75: Forced expiratory flow rate over 25% to 75% of vital capacity\n\nFor FEF25-75 percentage predicted the relative change is analyzed. If screening FEV1 percentage predicted is missing, it will be imputed by the baseline value.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline to End of Dosing (Day 29) and End of Off-cycle Period (Day 57) in Sputum Pseudomonas Aeruginosa Density (log10 Colony Forming Units(CFU) Per Gram Sputum)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TIP (Tobramycin Inhalation Powder)', 'description': 'Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).'}], 'classes': [{'title': 'Number of participants analyzed (29, 28): Baseline', 'categories': [{'measurements': [{'value': '7.5', 'spread': '1.49', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '1.58', 'groupId': 'OG001'}]}]}, {'title': 'Number of participants analyzed (14, 27): Day 29', 'categories': [{'measurements': [{'value': '-2.4', 'spread': '1.54', 'groupId': 'OG000', 'lowerLimit': '-1.7', 'upperLimit': '-0.7'}, {'value': '0.0', 'spread': '0.89', 'groupId': 'OG001', 'lowerLimit': '-0.6', 'upperLimit': '0.5'}]}]}, {'title': 'Number of participants analyzed (19, 24): Day 57', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '2.09', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '1.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 29, Day 57', 'description': 'P. aeruginosa sputum density refers to overall density, defined as the sum of biotypes (mucoid, dry and small colony variant).\n\nIf sub-isolates exist for CFU biotype mucoid or dry, then the sum of sub-isolates is analyzed.', 'unitOfMeasure': 'Log10 CFU (colony forming unit)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to End of Dosing (Day 29) and End of Off-cycle Period (Day 57) of Pseudomonas Aeruginosa Minimum Inhibitory Concentration (MIC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TIP (Tobramycin Inhalation Powder)', 'description': 'Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).'}], 'classes': [{'title': 'Number of participants analyzed (28, 29):Baseline', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.49', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '11.81', 'groupId': 'OG001'}]}]}, {'title': 'Number of participants analyzed (13, 27): Day 29', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '10.0', 'spread': '38.32', 'groupId': 'OG001'}]}]}, {'title': 'Number of participants analyzed (19, 24): Day 57', 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.49', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '6.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 29, Day 57', 'description': 'Maximum MIC values from all biotypes were used. Absolute values and changes in tobramycin MIC for P. aeruginosa from baseline are summarized by biotype. Overall, a high variability of MIC was observed within each treatment group. For the maximum of all biotypes, large differences in mean changes from baseline at Day 29 were observed between the TIP group and the placebo group.', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.'}, {'type': 'SECONDARY', 'title': 'Shift From Baseline in Laboratory Parameters to Above Upper/Lower Limit of Normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TIP (Tobramycin Inhalation Powder)', 'description': 'Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).'}], 'classes': [{'title': 'Hematology (Hem): Absolute Basophilis- low - low', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Hem: Absolute Basophilis - high', 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000'}, {'value': '10.0', 'groupId': 'OG001'}]}]}, {'title': 'Hem: Absolute Eosinophils - low', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Hem: Absolute Eosinophils - high', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}, {'value': '7.4', 'groupId': 'OG001'}]}]}, {'title': 'Hem: Absolute Lymphocytes - low', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}, {'value': '3.7', 'groupId': 'OG001'}]}]}, {'title': 'Hem: Absolute Lymphocytes - high', 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000'}, {'value': '9.5', 'groupId': 'OG001'}]}]}, {'title': 'Hem: Absolute Monocytes - low', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Hem: Absolute Monocytes - high', 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000'}, {'value': '19.2', 'groupId': 'OG001'}]}]}, {'title': 'Hem: Absolute Neutrophils (Seg. + Bands) - low', 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000'}, {'value': '10.3', 'groupId': 'OG001'}]}]}, {'title': 'Hem: Absolute Neutrophils (Seg. + Bands) - high', 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'Hem: Basophils - low', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Hem: Basophils - high', 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000'}, {'value': '40.0', 'groupId': 'OG001'}]}]}, {'title': 'Hem: Eosinophils - low', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Hem: Eosinophils - high', 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}, {'value': '14.8', 'groupId': 'OG001'}]}]}, {'title': 'Hem: Lymphocytes -low', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000'}, {'value': '14.3', 'groupId': 'OG001'}]}]}, {'title': 'Hem: Lymphocytes - high', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}, {'value': '7.7', 'groupId': 'OG001'}]}]}, {'title': 'Hem: Monocytes - low', 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Hem: Monocytes - high', 'categories': [{'measurements': [{'value': '27.8', 'groupId': 'OG000'}, {'value': '24.0', 'groupId': 'OG001'}]}]}, {'title': 'Hem: Neutrophils (Seg. + Bands) - low', 'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}]}]}, {'title': 'Hem: Neutrophils (Seg. + Bands) - high', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000'}, {'value': '6.9', 'groupId': 'OG001'}]}]}, {'title': 'Hem: Platelet count (direct) - low', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Hem: Platelet count (direct) - high', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}, {'value': '13.3', 'groupId': 'OG001'}]}]}, {'title': 'Hem: RBC- low', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Hem: RBC- high', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '9.1', 'groupId': 'OG001'}]}]}, {'title': 'Hem: WBC (total)- low', 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000'}, {'value': '3.7', 'groupId': 'OG001'}]}]}, {'title': 'Hem: WBC (total) - high', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}, {'value': '26.1', 'groupId': 'OG001'}]}]}, {'title': 'Hem: Hematocrit - low', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Hem: Hematocrit - high', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}, {'value': '14.8', 'groupId': 'OG001'}]}]}, {'title': 'Hem: Hemoglobin - low', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Hem: Hemoglobin - high', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}, {'value': '3.3', 'groupId': 'OG001'}]}]}, {'title': 'Biochemistry (Bio): Album - low', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Bio: Album - high', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '10.0', 'groupId': 'OG001'}]}]}, {'title': 'Bio: Alkaline phosphatase, serum - low', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Bio: Alkaline phosphatase, serum - high', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}, {'value': '4.3', 'groupId': 'OG001'}]}]}, {'title': 'Bio: Bilirubin (direct/conjugated) -low', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Bio: Bilirubin (direct/conjugated) -high', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}, {'value': '7.1', 'groupId': 'OG001'}]}]}, {'title': 'Bio: Bilirubin (total) - low', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Bio: Bilirubin (total) - high', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}, {'value': '3.3', 'groupId': 'OG001'}]}]}, {'title': 'Bio: Blood Urea Nitrogen (BUN) - low', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '13.8', 'groupId': 'OG001'}]}]}, {'title': 'Bio: Blood Urea Nitrogen (BUN) - high', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}]}]}, {'title': 'Bio: Calcium -low', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '12.9', 'groupId': 'OG001'}]}]}, {'title': 'Bio: Calcium -high', 'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000'}, {'value': '6.7', 'groupId': 'OG001'}]}]}, {'title': 'Bio: Chloride - low', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '6.5', 'groupId': 'OG001'}]}]}, {'title': 'Bio: Chloride - high', 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Bio: Creatinine - low', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}, {'title': 'Bio: Creatinine - high', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Bio: Gamma Glutamyltransferase - low', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}]}]}, {'title': 'Bio: Gamma Glutamyltransferase - high', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}]}]}, {'title': 'Bio: Glucose - low', 'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}]}]}, {'title': 'Bio: Glucose - high', 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000'}, {'value': '6.7', 'groupId': 'OG001'}]}]}, {'title': 'Bio: Phosphate (Inorganic Phosphorus) - low', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Bio: Phosphate (Inorganic Phosphorus) - high', 'categories': [{'measurements': [{'value': '19.2', 'groupId': 'OG000'}, {'value': '13.8', 'groupId': 'OG001'}]}]}, {'title': 'Bio: Potassioum - low', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}]}]}, {'title': 'Bio: Potassioum - high', 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Bio: SGOT (AST) - low', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}]}]}, {'title': 'Bio: SGOT (AST) - high', 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}, {'value': '12.0', 'groupId': 'OG001'}]}]}, {'title': 'Bio: SGPT (ALT) - low', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Bio: SGPT (ALT) - high', 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000'}, {'value': '13.0', 'groupId': 'OG001'}]}]}, {'title': 'Bio: Serum bicarbonate - low', 'categories': [{'measurements': [{'value': '47.6', 'groupId': 'OG000'}, {'value': '23.8', 'groupId': 'OG001'}]}]}, {'title': 'Bio: Serum bicarbonate - high', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Bio: Sodium - low', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '6.5', 'groupId': 'OG001'}]}]}, {'title': 'Bio: Sodium - high', 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Bio: Total Protein (Serum) - low', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}]}]}, {'title': 'Bio: Total Protein (Serum) - high', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}, {'value': '29.2', 'groupId': 'OG001'}]}]}, {'title': 'Bio: Uric Acid - low', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}]}]}, {'title': 'Bio: Uric Acid - high', 'categories': [{'measurements': [{'value': '10.7', 'groupId': 'OG000'}, {'value': '19.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Study completion', 'description': 'Hematology values shift from baseline to above upper/below lower limit of normal at any time post-baseline.\n\nBiochemistry values shift from baseline to above upper/below lower limit of normal at any time post-baseline.', 'unitOfMeasure': 'percentage of participants at risk', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: All randomized patients who received at least one dose of study drug. In all safety analyses patients were analyzed according to the treatment received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TIP (Tobramycin Inhalation Powder)', 'description': 'Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).'}], 'classes': [{'title': 'Respiratory, thoracic & mediastinal disorders', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}, {'value': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'Ear and labyrinth disorders', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}, {'value': '6.3', 'groupId': 'OG001'}]}]}, {'title': 'Infections and infestations', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'Gastrointestinal disorders', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'Metabolism and nutrition disorders', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'Nervous system disorders', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Renal and urinary disorders', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Skin and subcutaneous tissue disorder', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Blood and lymphatic system disorder', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'Injury, poisoning and procedural complications', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'Investigation', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '3.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First administration of study drug, study completion', 'description': 'Adverse Events (AEs) (on and off treatment) regardless of study relationship by primary system organ and treatment group.\n\nPrimary system organ classes are sorted in descending order of frequency in the TIP treatment group.\n\nA patient with more than one AE within a primary system organ class is counted only once for that class.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: All randomized patients who received at least one dose of study drug.In all safety analyses patients were analyzed according to the treatment received'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TIP (Tobramycin Inhalation Powder)', 'description': 'Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).'}], 'classes': [{'title': 'Lower limb fracture', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'Pneumonia', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '3.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Time of consent, 4 weeks after study completion', 'description': 'Serious Adverse Events (on and off treatment) by preferred term and treatment group.\n\nPreferred terms are sorted in descending order of frequency in the TIP treatment group.\n\nA patient with multiple occurrences of the same preferred term is counted only once in the preferred term.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: All randomized patients who received at least one dose of study drug. In all safety analyses patients were analyzed according to the treatment received.'}, {'type': 'SECONDARY', 'title': 'Acute Change in Airways Reactivity (FEV1 Percent Predicted) From Pre-dose to 30 Minutes After Completion of First Dose of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TIP (Tobramycin Inhalation Powder)', 'description': 'Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '8.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1, Day 29', 'description': 'Relative change = 100 \\* (30-m-post-dose - pre-dose)/pre-dose assessed by the number and percentage of patients with a decrease of ≥20 % in FEV1 % predicted from pre dose to 30 minutes post dose.\n\nDay 1 is the scheduled visit of first study drug administration.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: All randomized patients who received at least one dose of study drug.In all safety analyses patients were analyzed according to the treatment received.'}, {'type': 'SECONDARY', 'title': 'Tobramycin Serum Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TIP (Tobramycin Inhalation Powder)', 'description': 'Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.'}], 'classes': [{'title': 'Day1: 0 -1 hour (hr) post dose (28, 0)', 'categories': [{'measurements': [{'value': '0.83', 'spread': '0.40', 'groupId': 'OG000'}]}]}, {'title': 'Day 1: 1 -2 hours (hr) post dose (28, 0)', 'categories': [{'measurements': [{'value': '0.93', 'spread': '0.44', 'groupId': 'OG000'}]}]}, {'title': 'Day 1: 2 -6 hours (hr) post dose (29, 0)', 'categories': [{'measurements': [{'value': '0.73', 'spread': '0.39', 'groupId': 'OG000'}]}]}, {'title': 'Day 29: Pre-dose (27, 0)', 'categories': [{'measurements': [{'value': '0.41', 'spread': '0.51', 'groupId': 'OG000'}]}]}, {'title': 'Day 29: 0 -1 hr post dose (28, 0)', 'categories': [{'measurements': [{'value': '1.48', 'spread': '0.69', 'groupId': 'OG000'}]}]}, {'title': 'Day 29: 1 -2 hrs post dose (29, 0)', 'categories': [{'measurements': [{'value': '1.37', 'spread': '0.64', 'groupId': 'OG000'}]}]}, {'title': 'Day 29: 2 -6 hrs post dose (27, 0)', 'categories': [{'measurements': [{'value': '1.14', 'spread': '0.65', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0 - 1 hour post-dose, 1 -2 hours post-dose, 2 - 6 hours post-dose', 'description': 'Descriptive statistics of serum and sputum concentrations per scheduled sampling time.\n\nDetectable concentration values at pre-dose on Day 1 were excluded from the analysis.', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: All randomized patients who received at least one dose of study drug. In all safety analyses patients were analyzed according to the treatment received.\n\nThis measures the concentration of active substance in the body at different time-point to evaluate there is abnormal accumulation of active substance. Not for Placebo Patients.'}, {'type': 'PRIMARY', 'title': 'Pre-planned Sensitivity Analysis: Absolute Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent (%) Predicted to End of Dosing (Day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TIP (Tobramycin Inhalation Powder)', 'description': 'Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).'}], 'classes': [{'title': 'Participants analyzed: ITT Population (31, 28)', 'categories': [{'measurements': [{'value': '4.9', 'spread': '1.59', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.70', 'groupId': 'OG001'}]}]}, {'title': 'Parts. analyzed: Modified ITT Pop (25, 27)', 'categories': [{'measurements': [{'value': '5.7', 'spread': '1.78', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.79', 'groupId': 'OG001'}]}]}, {'title': 'Parts. analyzed: Observed Cases, ITT Pop (27, 27)', 'categories': [{'measurements': [{'value': '6.1', 'spread': '1.84', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.80', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 29', 'description': 'Absolute change in percentage predicted FEV1 in the Intent-to-treat (ITT), modified ITT (mITT) and Observed cases in the ITT populations were calculated from an adjusted analysis ANOVA model.\n\nIn the adjusted analysis model: response = treatment + screening FEV1 % predicted (\\<50 and \\>=50) + age (\\<13 and \\>=13) + error.\n\nSignificance for the FEV1 % predicted is reached for p-values \\<= 0.05. There were 3 patients who had no screening nor baseline values (due to inadequate spirometry) and so were excluded from all change from baseline analyses.', 'unitOfMeasure': 'change in percentage', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT: All randomized patients (pts) received at least one dose of study drug. Missing or unacceptable Day 29 spirometry test -change from baseline FEV1 % predicted imputed using last available post-baseline value or 0. mITT: Pts with unacceptable FEV1 measurements excluded. Observed cases: Pts with missing or unacceptable FEV1 measurements excluded.'}, {'type': 'PRIMARY', 'title': 'Post-hoc: Relative Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent Predicted to End of Dosing (Day 29) Without Outlier', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TIP (Tobramycin Inhalation Powder)', 'description': 'Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).'}], 'classes': [{'title': 'Participants analyzed: ITT Population (30, 28)', 'categories': [{'measurements': [{'value': '10.4', 'spread': '2.81', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '2.92', 'groupId': 'OG001'}]}]}, {'title': 'Parts. analyzed: Modified ITT Pop (24, 27)', 'categories': [{'measurements': [{'value': '12.4', 'spread': '3.14', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '3.05', 'groupId': 'OG001'}]}]}, {'title': 'Parts. analyzed: Observed Cases, ITT Pop (26, 27)', 'categories': [{'measurements': [{'value': '13.1', 'spread': '3.25', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '3.08', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 29', 'description': 'Relative change in percentage predicted FEV1 without outlier (outliers with respect to FEV1 values and PK data), in the Intent-to-treat (ITT), modified ITT (mITT) and Observed cases in the ITT populations were calculated from an adjusted analysis ANOVA model.', 'unitOfMeasure': 'change in percentage', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT: All randomized patients (pts) received at least one dose of study drug. Missing or unacceptable Day 29 spirometry test -change from baseline FEV1 % predicted imputed using last available post-baseline value or 0. mITT: Pts with unacceptable FEV1 measurements excluded. Observed cases: Pts with missing or unacceptable FEV1 measurements excluded.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TIP (Tobramycin Inhalation Powder)', 'description': 'Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Although 32 patients were randomized to the TIP group and 30 to the Placebo group, the ITT population included 2 patients allocated to the TIP group but received placebo due to Investigator error during the drug dispensation process. The safety population contained 30 patients who were treated with TIP and 32 patients who were treated with placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'TIP (Tobramycin Inhalation Powder)', 'description': 'Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '12.9', 'spread': '4.25', 'groupId': 'BG000'}, {'value': '12.9', 'spread': '4.68', 'groupId': 'BG001'}, {'value': '12.9', 'spread': '4.44', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<13 years', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': '>= 13 years', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Forced Expiratory Volume in one second (FEV1) percentage predicted', 'classes': [{'categories': [{'measurements': [{'value': '59.1', 'spread': '18.18', 'groupId': 'BG000'}, {'value': '59.3', 'spread': '16.61', 'groupId': 'BG001'}, {'value': '59.2', 'spread': '17.25', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '* Any spirometry values that are listed as missing at Screening and/or Baseline FEV1 % predicted can include data that was captured but identified as technically unacceptable.\n* Baseline is defined as the latest measurement prior to first dosing of study medication.', 'unitOfMeasure': 'Percentage', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline P. aeruginosa sputum density', 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'spread': '1.53', 'groupId': 'BG000'}, {'value': '7.4', 'spread': '1.55', 'groupId': 'BG001'}, {'value': '7.4', 'spread': '1.52', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '* Overall density, defined as the sum of biotypes (mucoid, dry and small colony variant).\n* Baseline is defined as the latest measurement prior to first dosing of study medication.\n\n * If sub-isolates existed for CFU biotype mucoid or dry, then the sum of sub-isolates is analyzed.', 'unitOfMeasure': 'Log10 CFU (colony forming unit)', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-01', 'studyFirstSubmitDate': '2009-06-04', 'resultsFirstSubmitDate': '2012-05-05', 'studyFirstSubmitQcDate': '2009-06-10', 'lastUpdatePostDateStruct': {'date': '2012-10-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-10-01', 'studyFirstPostDateStruct': {'date': '2009-06-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent Predicted to End of Dosing (Day 29)', 'timeFrame': 'Baseline, Day 29', 'description': 'Relative change in percentage predicted FEV1 in the Intent-to-treat (ITT), modified ITT (mITT) and Observed cases in the ITT populations were calculated from an adjusted analysis ANOVA model.\n\nITT Patients with missing or unacceptable Day 29 spirometry measurements had their primary endpoint data imputed with zero.\n\nBSL = Baseline, defined as the latest measurement prior to the first dosing of study medication\n\n\\- Relative change = 100 \\* (value - baseline) / baseline There were 3 patients who had no screening nor baseline values (due to inadequate spirometry) and so were excluded from all change from baseline analyses.'}, {'measure': 'Pre-planned Sensitivity Analysis: Absolute Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent (%) Predicted to End of Dosing (Day 29)', 'timeFrame': 'Baseline, Day 29', 'description': 'Absolute change in percentage predicted FEV1 in the Intent-to-treat (ITT), modified ITT (mITT) and Observed cases in the ITT populations were calculated from an adjusted analysis ANOVA model.\n\nIn the adjusted analysis model: response = treatment + screening FEV1 % predicted (\\<50 and \\>=50) + age (\\<13 and \\>=13) + error.\n\nSignificance for the FEV1 % predicted is reached for p-values \\<= 0.05. There were 3 patients who had no screening nor baseline values (due to inadequate spirometry) and so were excluded from all change from baseline analyses.'}, {'measure': 'Post-hoc: Relative Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent Predicted to End of Dosing (Day 29) Without Outlier', 'timeFrame': 'Baseline, Day 29', 'description': 'Relative change in percentage predicted FEV1 without outlier (outliers with respect to FEV1 values and PK data), in the Intent-to-treat (ITT), modified ITT (mITT) and Observed cases in the ITT populations were calculated from an adjusted analysis ANOVA model.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline of Forced Vital Capacity (FVC) Percent Predicted to End of Dosing (Day 29) and to the End of Off-cycle Period (Day 57)', 'timeFrame': 'Baseline, Day 29, Day 57', 'description': 'Results of statistical analysis were calculated from an ANOVA model. Baseline is defined as the latest measurement prior to the first dosing of study medication.\n\nResponse (percentage change) = treatment + Screening FEV1 percentage predicted (\\<50 and \\>=50) + age (\\<13 and \\>=13) + error'}, {'measure': 'Change From Baseline of Forced Expiratory Flow Rate Over 25 and 75 Percent. (FEF25-75%) Predicted to End of Dosing (Day 29) and End of Off-cycle Period (Day 57)', 'timeFrame': 'Baseline, Day 29, Day 57', 'description': 'FEF25-75: Forced expiratory flow rate over 25% to 75% of vital capacity\n\nFor FEF25-75 percentage predicted the relative change is analyzed. If screening FEV1 percentage predicted is missing, it will be imputed by the baseline value.'}, {'measure': 'Absolute Change From Baseline to End of Dosing (Day 29) and End of Off-cycle Period (Day 57) in Sputum Pseudomonas Aeruginosa Density (log10 Colony Forming Units(CFU) Per Gram Sputum)', 'timeFrame': 'Baseline, Day 29, Day 57', 'description': 'P. aeruginosa sputum density refers to overall density, defined as the sum of biotypes (mucoid, dry and small colony variant).\n\nIf sub-isolates exist for CFU biotype mucoid or dry, then the sum of sub-isolates is analyzed.'}, {'measure': 'Change From Baseline to End of Dosing (Day 29) and End of Off-cycle Period (Day 57) of Pseudomonas Aeruginosa Minimum Inhibitory Concentration (MIC)', 'timeFrame': 'Baseline, Day 29, Day 57', 'description': 'Maximum MIC values from all biotypes were used. Absolute values and changes in tobramycin MIC for P. aeruginosa from baseline are summarized by biotype. Overall, a high variability of MIC was observed within each treatment group. For the maximum of all biotypes, large differences in mean changes from baseline at Day 29 were observed between the TIP group and the placebo group.'}, {'measure': 'Shift From Baseline in Laboratory Parameters to Above Upper/Lower Limit of Normal', 'timeFrame': 'Baseline, Study completion', 'description': 'Hematology values shift from baseline to above upper/below lower limit of normal at any time post-baseline.\n\nBiochemistry values shift from baseline to above upper/below lower limit of normal at any time post-baseline.'}, {'measure': 'Percentage of Participants With Adverse Events (AEs)', 'timeFrame': 'First administration of study drug, study completion', 'description': 'Adverse Events (AEs) (on and off treatment) regardless of study relationship by primary system organ and treatment group.\n\nPrimary system organ classes are sorted in descending order of frequency in the TIP treatment group.\n\nA patient with more than one AE within a primary system organ class is counted only once for that class.'}, {'measure': 'Percentage of Participants With Serious Adverse Events (SAEs)', 'timeFrame': 'Time of consent, 4 weeks after study completion', 'description': 'Serious Adverse Events (on and off treatment) by preferred term and treatment group.\n\nPreferred terms are sorted in descending order of frequency in the TIP treatment group.\n\nA patient with multiple occurrences of the same preferred term is counted only once in the preferred term.'}, {'measure': 'Acute Change in Airways Reactivity (FEV1 Percent Predicted) From Pre-dose to 30 Minutes After Completion of First Dose of Study Drug', 'timeFrame': 'Day 1, Day 29', 'description': 'Relative change = 100 \\* (30-m-post-dose - pre-dose)/pre-dose assessed by the number and percentage of patients with a decrease of ≥20 % in FEV1 % predicted from pre dose to 30 minutes post dose.\n\nDay 1 is the scheduled visit of first study drug administration.'}, {'measure': 'Tobramycin Serum Concentration', 'timeFrame': 'Pre-dose, 0 - 1 hour post-dose, 1 -2 hours post-dose, 2 - 6 hours post-dose', 'description': 'Descriptive statistics of serum and sputum concentrations per scheduled sampling time.\n\nDetectable concentration values at pre-dose on Day 1 were excluded from the analysis.'}]}, 'conditionsModule': {'keywords': ['Tobramycin Inhalation Powder', 'Cystic fibrosis', 'Lung diseases', 'Anti-Bacterial Agents', 'Treatment of infections with P. aeruginosa in cystic fibrosis subjects'], 'conditions': ['Cystic Fibrosis']}, 'referencesModule': {'references': [{'pmid': '23672633', 'type': 'DERIVED', 'citation': 'Galeva I, Konstan MW, Higgins M, Angyalosi G, Brockhaus F, Piggott S, Thomas K, Chuchalin AG. Tobramycin inhalation powder manufactured by improved process in cystic fibrosis: the randomized EDIT trial. Curr Med Res Opin. 2013 Aug;29(8):947-56. doi: 10.1185/03007995.2013.805122. Epub 2013 Jun 5.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to show how well tobramycin inhalation powder works and how safe it is when produced by a modified manufacturing process'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written informed consent given by adults or by the parents/legal guardian in combination with the patient's assent, if capable of assenting, before any assessment was performed\n* Confirmed diagnosis of Cystic Fibrosis (CF) by the presence of one or more clinical features of CF in addition to:\n\n * a quantitative pilocarpine iontophoresis sweat chloride test of \\>60 mEq/L; or\n * identification of well-characterized disease-causing mutations in each CFTR gene; or\n * an abnormal nasal transepithelial potential difference characteristic of CF.\n* Forced Expiratory Volume in one second (FEV1) at screening must have been ≥25% and ≤80% of normal predicted values for age, sex, and height based on Knudson criteria\n* P. aeruginosa must have been present in a sputum/deep-throat cough swab culture (or bronchoalveolar lavage \\[BAL\\]) within 6 months prior to screening and in the sputum/deep-throat cough swab culture at the screening visit\n* Able to expectorate a sputum sample or provide a deep throat cough swab at screening\n* Able to comply with all protocol requirements\n* Use of an effective means of contraception in females of childbearing potential\n* Clinically stable in the opinion of the investigator to be treated according to this protocol\n\nExclusion Criteria:\n\n* FEV1 at baseline (Visit 2) \\<25% or \\>80% of normal predicted values for age, sex, and height based on Knudson criteria, and/or FEV1 at baseline (Visit 2) deviated by ≥10% from the FEV1 measured at screening (Visit 1)\n* Any use of inhaled anti-pseudomonal antibiotics within 4 months prior to screening\n* Any use of systemic anti-pseudomonal antibiotics within 28 days prior to study drug administration\n* Serum creatinine 2 mg/dL or above, blood urea nitrogen (BUN) 40 mg/dL or above, or an abnormal urinalysis defined as 2+ or greater proteinuria\n* Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics\n* Signs and symptoms of acute pulmonary disease, e.g. pneumonia, pneumothorax\n* Administration of any investigational drug within 30 days prior to enrollment\n* Any previous exposure to tobramycin dry powder for inhalation (TIP)\n* Administration of loop diuretics within 7 days prior to study drug administration\n* Initiation of treatment with chronic macrolide therapy within 28 days prior to study drug administration\n* Initiation of treatment with dornase alfa within 28 days prior to study drug administration\n* Initiation of treatment with inhaled steroids (or increased dose) within 28 days prior to study drug administration\n* Initiation of treatment with inhaled hypertonic saline (HS) within 28 days prior to study drug administration\n* Personal history of abnormal hearing or family history of abnormal hearing other than typical hearing loss associated with the aging process\n* Known abnormal result from any audiology testing (defined as either a unilateral puretone audiometry test showing a threshold elevation \\>20 dB at any frequency across the frequency range 0.25 kHz to 8 kHz or the absence of emission at the evoked otoacoustic emission test)\n* History of sputum culture or throat swab (or BAL) culture yielding Burkholderia cepacia (B. cepacia) within 2 years prior to screening and/or sputum culture yielding B. cepacia at screening\n* Hemoptysis of more than 60 mL at any time within 30 days prior to study drug administration\n* History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of evidence of local recurrence or metastases\n* Patients with clinically significant laboratory abnormalities (not associated with the study indication) at screening\n* Patients or caregivers with a history of noncompliance to medical regimens and patients or caregivers who are considered potentially unreliable\n* Pregnant or nursing (lactating) women\n* Women of child-bearing potential unless they used two reliable birth control methods\n\nOther protocol-defined inclusion/exclusion criteria may apply"}, 'identificationModule': {'nctId': 'NCT00918957', 'acronym': 'EDIT', 'briefTitle': 'A Study of Tobramycin Inhalation Powder From a Modified Manufacturing Process Versus Placebo', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder From a Modified Manufacturing Process (TIPnew).', 'orgStudyIdInfo': {'id': 'CTBM100C2303'}, 'secondaryIdInfos': [{'id': '2008-002318-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TIP (Tobramycin Inhalation Powder)', 'description': 'Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.', 'interventionNames': ['Drug: Tobramycin Inhalation Powder']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.), in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tobramycin Inhalation Powder', 'type': 'DRUG', 'description': 'Tobramycin Inhalation Powder as produced by a modified manufacturing process TIP. TIP was provided in hard capsules each containing 28 mg active ingredient (tobramycin); Capsules were packaged in blister cards and administered by the T-326 Inhaler.', 'armGroupLabels': ['TIP (Tobramycin Inhalation Powder)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo inhalation powder consisting of the excipients used for TIP. Placebo was provided in hard capsules, containing 20 mg placebo powder, which were packaged in blister cards, matching in appearance to TIP. Capsules were administered by the T-326 Inhaler.', 'armGroupLabels': ['Placebo']}]}, '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': 'Alexandria', 'country': 'Egypt', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}, {'city': 'Giza', 'country': 'Egypt', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}, {'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': 'Chandigarh', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 30.73629, 'lon': 76.7884}}, {'city': 'Hyderabad', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'city': 'New Delhi', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'city': 'Vellore', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 12.9184, 'lon': 79.13255}}, {'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': 'Voronezh', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.66833, 'lon': 39.19204}}, {'city': 'Yaroslavi', 'country': 'Russia', 'facility': 'Novartis Investigator Site'}, {'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'}}}}