{ "FullStudy":{ "Rank":217571, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01519661", "OrgStudyIdInfo":{ "OrgStudyId":"CTBM100C2401" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"2011-002000-32", "SecondaryIdType":"EudraCT Number" } ] }, "Organization":{ "OrgFullName":"Novartis", "OrgClass":"INDUSTRY" }, "BriefTitle":"Long Term Safety of Tobramycin Inhalation Powder in Patients With Cystic Fibrosis", "OfficialTitle":"A Single Arm, Open-label, Multicenter, Phase IV Trial to Assess Long Term Safety of Tobramycin Inhalation Powder (TIP) in Patients With Cystic Fibrosis" }, "StatusModule":{ "StatusVerifiedDate":"February 2015", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"January 2014", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"January 2014", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 24, 2012", "StudyFirstSubmitQCDate":"January 26, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 27, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"December 17, 2014", "ResultsFirstSubmitQCDate":"February 8, 2015", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"February 10, 2015", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"February 8, 2015", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"February 10, 2015", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Novartis Pharmaceuticals", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{}, "DescriptionModule":{ "BriefSummary":"This study assessed the long term safety data for the use of tobramycin inhalation powder in patients suffering from cystic fibrosis who have a chronic pulmonary infection with Pseudomonas aeruginosa." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Pulmonary Infections", "Pseudomonas Aeruginosa in Cystic Fibrosis" ] }, "KeywordList":{ "Keyword":[ "Tobramycin Inhalation powder", "Cystic fibrosis", "Lung disease", "Anti-bacterial agents" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] }, "DesignInfo":{ "DesignAllocation":"Non-Randomized", "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"157", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Tobramycin Inhalation Powder (TIP)", "ArmGroupType":"Experimental", "ArmGroupDescription":"Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: TBM100" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"TBM100", "InterventionDescription":"Tobramycin inhalation powder was assigned as four capsules at 28mg dosage strength. It was inhaled b.i.d in the morning and in the evening via the T-326 Inhaler.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Tobramycin Inhalation Powder (TIP)" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Percentage of Participants With Treatment Emergent Adverse Events, Serious Adverse Events (SAEs) and Deaths", "PrimaryOutcomeDescription":"Adverse events were deemed treatment-emergent if the onset date/time was on or after the date and time of first study drug. All adverse events were included after this time during both on and off-treatment periods.", "PrimaryOutcomeTimeFrame":"337 days" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted", "SecondaryOutcomeDescription":"Spirometry was performed at each visit. FEV1, FVC, and FEF25-75 were recorded at all visits according to American Thoracic Society (ATS) guidelines. FEV1 = the volume of air expired in 1 second. FEV1 % predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant's age, gender and height. FVC (forced vital capacity) = the maximal volume of air exhaled with maximally forced effort from a position of maximal inspiration. FEF25-75 = forced expiratory flow from 25% to 75% of the FVC. Relative change in FEV1 % predicted from baseline to pre-dose day X = ((pre-dose day X FEV1 % predicted - baseline FEV1 % predicted) / baseline FEV1 % predicted) • 100.", "SecondaryOutcomeTimeFrame":"Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337. All study visits except baseline and day 337 occurred at the end of a 28-day on-treatment period of a cycle. Day 337 was the end of the final 28-day off treatment period." },{ "SecondaryOutcomeMeasure":"Relative Change From Baseline in FVC Percent Predicted", "SecondaryOutcomeDescription":"Spirometry was performed at each visit. FEV1, FVC, and FEF25-75 were recorded at all visits according to American Thoracic Society (ATS) guidelines. FEV1 = the volume of air expired in 1 second. FEV1 % predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant's age, gender and height. FVC (forced vital capacity) = the maximal volume of air exhaled with maximally forced effort from a position of maximal inspiration. FEF25-75 = forced expiratory flow from 25% to 75% of the FVC. Relative change in FVC % predicted from baseline to pre-dose day X = ((pre-dose day X FVC % predicted - baseline FVC % predicted) / baseline FVC % predicted) • 100.", "SecondaryOutcomeTimeFrame":"Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337. All study visits except baseline and day 337 occurred at the end of a 28-day on-treatment period of a cycle. Day 337 was the end of the final 28-day off treatment period." },{ "SecondaryOutcomeMeasure":"Relative Change From Baseline in FEF Rate Over 25 to 75 Percent of Vital Capacity Predicted", "SecondaryOutcomeDescription":"Spirometry was performed at each visit. FEV1, FVC, and FEF25-75 were recored at all visits according to American Thoracic Society (ATS) guidelines. FEV1 = the volume of air expired in 1 second. FEV1 % predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant's age, gender and height. FVC (forced vital capacity) = the maximal volume of air exhaled with maximally forced effort from a position of maximal inspiration. FEF25-75 = forced expiratory flow from 25% to 75% of the FVC. Relative change in FEEF25-75 from baseline to pre-dose day X = ((pre-dose day X FEF25-75 - baseline FEF25-75) / baseline FEF25-75) • 100.", "SecondaryOutcomeTimeFrame":"Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337. All study visits except baseline and day 337 occurred at the end of a 28-day on-treatment period of a cycle. Day 337 was the end of the final 28-day off treatment period." },{ "SecondaryOutcomeMeasure":"Change From Baseline in Pseudomonas Aeruginosa Colony Forming Units in Sputum", "SecondaryOutcomeDescription":"Sputum was collected in sterile containers and cultured for Pseudomonas aeruginosa (Pa.) (quantitative test) and other typical Cystic Fibrosis respiratory pathogens. The Pa. biotypes measured were mucoid, dry and small colony variant. Results are presented for the sum of all biotypes of Pa, with data transformed using a base 10 logarithm.", "SecondaryOutcomeTimeFrame":"Baseline, day 1, day 29, day 85, day 141, day 197, day 253, day 309, day 337" },{ "SecondaryOutcomeMeasure":"Tobramycin MIC 50 and MIC 90 Values Over All Isolates for the Sum of All Biotypes (Mucoid, Dry and Small Colony Variant) of Pseudomonas Aeruginosa", "SecondaryOutcomeDescription":"Tobramycin MIC 50 and MIC 90 values were defined as the lowest concentration of tobramycin required to inhibit 50% and 90%, respectively, of the P. aeruginosa strains tested.", "SecondaryOutcomeTimeFrame":"Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337" },{ "SecondaryOutcomeMeasure":"Percentage of Participants Hospitalized Due to Serious Respiratory-related Adverse Events", "SecondaryOutcomeTimeFrame":"Day 337" },{ "SecondaryOutcomeMeasure":"Number of Hospitalization Days Due to Serious Respiratory-related Adverse Events", "SecondaryOutcomeDescription":"The total number of hospitalization days due to serious respiratory-related adverse events was analyzed.", "SecondaryOutcomeTimeFrame":"Day 337" },{ "SecondaryOutcomeMeasure":"Time to First Hospitalization Due to Serious Respiratory-related Adverse Events", "SecondaryOutcomeDescription":"The day of first hospitalization due to serious respiratory-related adverse events was analyzed.", "SecondaryOutcomeTimeFrame":"Day 337" },{ "SecondaryOutcomeMeasure":"Percentage of Participants Who Used New Anti-pseudomonal Antibiotics", "SecondaryOutcomeTimeFrame":"Day 337" },{ "SecondaryOutcomeMeasure":"Number of Days of New Anti-pseudomonal Antibiotic Use", "SecondaryOutcomeDescription":"The total number of days of new anti-pseudomonal antibiotic use was analyzed.", "SecondaryOutcomeTimeFrame":"Day 337" },{ "SecondaryOutcomeMeasure":"Time to Use of New Anti-pseudomonal Antibiotic", "SecondaryOutcomeDescription":"Time to first use of new anti-pseudomonal antibiotic was analyzed.", "SecondaryOutcomeTimeFrame":"Day 337" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nConfirmed diagnosis of Cystic Fibrosis\nFEV1 at screening must be between 25 and 75 percent of normal predicted values for age, sex and height based on the Knudson equation\nPseudomonas aeruginosa must be present in a sputum / deep cough throat swab culture or bronchoalveolar lavage within 6 months prior to screening and in the sputum/deep-throat cough swab culture at screening\n\nExclusion Criteria:\n\nHistory of sputum culture or deep cough throat swab culture yielding Burkholderia cenocepacia complex within 2 years prior to screening and /or sputum culture yielding Burkholderia cenocepacia at screening\nHemoptysis more than 60mL at any time within 30 days prior to study drug administration\nHistory of hearing loss or chronic tinnitus deemed clinically significant\nSerum creatinine 2mg/dl or more, BUN 40mg/dl or more, or an abnormal urinalysis defined as 2+ or greater proteinuria at screening\nKnown local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics\nPatients who are regularly receiving more than 1 class of inhaled anti-pseudomonal antibiotic\nAny use of inhaled or systemic anti-pseudomonal antibiotic within 28 days prior to study drug administration\nUse of loop diuretics within 7 days prior to study drug administration\n\nOther protocol-defined inclusion/exclusion criteria may apply.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"6 Years", "StdAgeList":{ "StdAge":[ "Child", "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Novartis Pharmaceuticals", "OverallOfficialAffiliation":"Novartis Pharmaceuticals", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Novartis Investigative Site", "LocationCity":"Little Rock", "LocationState":"Arkansas", "LocationZip":"72205", 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"LocationCountry":"France" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Montpellier", "LocationZip":"34059", "LocationCountry":"France" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Paris", "LocationZip":"75006", "LocationCountry":"France" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Reims", "LocationZip":"51092", "LocationCountry":"France" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Roscoff", "LocationZip":"29684", "LocationCountry":"France" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Essen", "LocationZip":"45147", "LocationCountry":"Germany" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Frankfurt", "LocationZip":"60590", "LocationCountry":"Germany" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Budapest", "LocationZip":"1121", "LocationCountry":"Hungary" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Firenze", "LocationState":"FI", "LocationZip":"50139", "LocationCountry":"Italy" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Genova", "LocationState":"GE", "LocationZip":"16147", "LocationCountry":"Italy" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Messina", "LocationState":"ME", "LocationZip":"98125", "LocationCountry":"Italy" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Verona", "LocationState":"VR", "LocationZip":"37126", "LocationCountry":"Italy" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Napoli", "LocationZip":"80131", "LocationCountry":"Italy" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Palermo", "LocationZip":"90100", "LocationCountry":"Italy" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Roma", "LocationZip":"00161", "LocationCountry":"Italy" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Mexico", "LocationState":"Distrito Federal", "LocationZip":"06720", "LocationCountry":"Mexico" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Monterrey", "LocationState":"Nuevo León", "LocationZip":"64460", "LocationCountry":"Mexico" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Barcelona", "LocationState":"Cataluña", "LocationCountry":"Spain" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Valencia", "LocationState":"Comunidad Valenciana", "LocationZip":"46026", "LocationCountry":"Spain" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"27435882", "ReferenceType":"derived", "ReferenceCitation":"Sommerwerck U, Virella-Lowell I, Angyalosi G, Viegas A, Cao W, Debonnett L. Long-term safety of tobramycin inhalation powder in patients with cystic fibrosis: phase IV (ETOILES) study. Curr Med Res Opin. 2016 Nov;32(11):1789-1795. Epub 2016 Sep 9." } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Tobramycin Inhalation Powder (TIP)", "FlowGroupDescription":"Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"157" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"96" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"61" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Protocol deviation", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"6" } ] } },{ "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"3" } ] } },{ "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"17" } ] } },{ "FlowDropWithdrawType":"Lack of Efficacy", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"6" } ] } },{ "FlowDropWithdrawType":"Adverse Event", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"29" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Tobramycin Inhalation Powder (TIP)", "BaselineGroupDescription":"Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy." } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"157" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"Years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"27.8", "BaselineMeasurementSpread":"10.82" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"60" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"97" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Weight", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"kilograms (kg)", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"57.4", "BaselineMeasurementSpread":"13.52" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Body Mass Index", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"kg/m^2", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"20.5", "BaselineMeasurementSpread":"3.35" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"FEV1 % predicted", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"percent", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"50.2", "BaselineMeasurementSpread":"13.95" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"FVC % predicted", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"percent", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"73.9", "BaselineMeasurementSpread":"15.88" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"FEF25-75 % predicted", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"percent", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"21.8", "BaselineMeasurementSpread":"12.75" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sputum density of P. aeruginosa - sum of all biotypes", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"log10 Colony Forming Units (CFU)", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"7.6", "BaselineMeasurementSpread":"1.65" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"P. aeruginosa tobramycin minimal inhibitory concentration (MIC)", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"percentage of participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"> 8 ug/mL", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"26.1" } ] } } ] } },{ "BaselineClassTitle":"<= 8 ug/mL", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"73.2" } ] } } ] } },{ "BaselineClassTitle":"Missing", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0.6" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Percentage of Participants With Treatment Emergent Adverse Events, Serious Adverse Events (SAEs) and Deaths", "OutcomeMeasureDescription":"Adverse events were deemed treatment-emergent if the onset date/time was on or after the date and time of first study drug. All adverse events were included after this time during both on and off-treatment periods.", "OutcomeMeasurePopulationDescription":"Safety set: The safety set included all participants who received at least one dose of study drug.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"337 days", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Tobramycin Inhalation Powder (TIP)", "OutcomeGroupDescription":"Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"157" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Adverse events (serious and non-serious)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"85.4" } ] } } ] } },{ "OutcomeClassTitle":"Serious adverse events", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"31.2" } ] } } ] } },{ "OutcomeClassTitle":"Deaths", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted", "OutcomeMeasureDescription":"Spirometry was performed at each visit. FEV1, FVC, and FEF25-75 were recorded at all visits according to American Thoracic Society (ATS) guidelines. FEV1 = the volume of air expired in 1 second. FEV1 % predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant's age, gender and height. FVC (forced vital capacity) = the maximal volume of air exhaled with maximally forced effort from a position of maximal inspiration. FEF25-75 = forced expiratory flow from 25% to 75% of the FVC. Relative change in FEV1 % predicted from baseline to pre-dose day X = ((pre-dose day X FEV1 % predicted - baseline FEV1 % predicted) / baseline FEV1 % predicted) • 100.", "OutcomeMeasurePopulationDescription":"Participants from the safety set who had FEV1 percent predicted values at both baseline and the post baseline time points were analyzed at each given time point. The safety set included all participants who received at least one dose of study drug.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"Percent change", "OutcomeMeasureTimeFrame":"Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337. All study visits except baseline and day 337 occurred at the end of a 28-day on-treatment period of a cycle. Day 337 was the end of the final 28-day off treatment period.", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Tobramycin Inhalation Powder (TIP)", "OutcomeGroupDescription":"Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"157" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Day 29, Cycle 1 (n=149)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.8", "OutcomeMeasurementSpread":"17.17" } ] } } ] } },{ "OutcomeClassTitle":"Day 85, Cycle 2 (n=146)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementSpread":"17.09" } ] } } ] } },{ "OutcomeClassTitle":"Day 141, Cycle 3 (n=128)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.2", "OutcomeMeasurementSpread":"15.13" } ] } } ] } },{ "OutcomeClassTitle":"Day 197, Cycle 4 (n=116)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.2", "OutcomeMeasurementSpread":"15.36" } ] } } ] } },{ "OutcomeClassTitle":"Day 253, Cycle 5 (n=105)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.5", "OutcomeMeasurementSpread":"17.19" } ] } } ] } },{ "OutcomeClassTitle":"Day 309, Cycle 6 (n=100)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.9", "OutcomeMeasurementSpread":"14.55" } ] } } ] } },{ "OutcomeClassTitle":"Day 337, Completion (n=93)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-3.5", "OutcomeMeasurementSpread":"16.81" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Relative Change From Baseline in FVC Percent Predicted", "OutcomeMeasureDescription":"Spirometry was performed at each visit. FEV1, FVC, and FEF25-75 were recorded at all visits according to American Thoracic Society (ATS) guidelines. FEV1 = the volume of air expired in 1 second. FEV1 % predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant's age, gender and height. FVC (forced vital capacity) = the maximal volume of air exhaled with maximally forced effort from a position of maximal inspiration. FEF25-75 = forced expiratory flow from 25% to 75% of the FVC. Relative change in FVC % predicted from baseline to pre-dose day X = ((pre-dose day X FVC % predicted - baseline FVC % predicted) / baseline FVC % predicted) • 100.", "OutcomeMeasurePopulationDescription":"Participants from the safety set who had values at both baseline and the given assessment day were included in the analysis for that assessment day. Therefore, the 'n' for each assessment day is different. The safety set included all participants who received at least one dose of study drug.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"Percent change", "OutcomeMeasureTimeFrame":"Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337. All study visits except baseline and day 337 occurred at the end of a 28-day on-treatment period of a cycle. Day 337 was the end of the final 28-day off treatment period.", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Tobramycin Inhalation Powder (TIP)", "OutcomeGroupDescription":"Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"157" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Day 29, Cycle 1 (n=149)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-2.5", "OutcomeMeasurementSpread":"12.95" } ] } } ] } },{ "OutcomeClassTitle":"Day 85, Cycle 2 (n=146)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-2.8", "OutcomeMeasurementSpread":"12.81" } ] } } ] } },{ "OutcomeClassTitle":"Day 141, Cycle 3 (n=128)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-2.1", "OutcomeMeasurementSpread":"12.25" } ] } } ] } },{ "OutcomeClassTitle":"Day 197, Cycle 4 (n=116)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.8", "OutcomeMeasurementSpread":"12.64" } ] } } ] } },{ "OutcomeClassTitle":"Day 253, Cycle 5 (n=105)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-3.5", "OutcomeMeasurementSpread":"13.11" } ] } } ] } },{ "OutcomeClassTitle":"Day 309, Cycle 6 (n=100)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-3.1", "OutcomeMeasurementSpread":"12.17" } ] } } ] } },{ "OutcomeClassTitle":"Day 337, Completion (n=93)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-2.8", "OutcomeMeasurementSpread":"13.50" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Relative Change From Baseline in FEF Rate Over 25 to 75 Percent of Vital Capacity Predicted", "OutcomeMeasureDescription":"Spirometry was performed at each visit. FEV1, FVC, and FEF25-75 were recored at all visits according to American Thoracic Society (ATS) guidelines. FEV1 = the volume of air expired in 1 second. FEV1 % predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant's age, gender and height. FVC (forced vital capacity) = the maximal volume of air exhaled with maximally forced effort from a position of maximal inspiration. FEF25-75 = forced expiratory flow from 25% to 75% of the FVC. Relative change in FEEF25-75 from baseline to pre-dose day X = ((pre-dose day X FEF25-75 - baseline FEF25-75) / baseline FEF25-75) • 100.", "OutcomeMeasurePopulationDescription":"Participants from the safety set who had values at both baseline and the given assessment day were included in the analysis for that assessment day. Therefore, the 'n' for each assessment day is different. The safety set included all participants who received at least one dose of study drug.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"Percent change", "OutcomeMeasureTimeFrame":"Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337. All study visits except baseline and day 337 occurred at the end of a 28-day on-treatment period of a cycle. Day 337 was the end of the final 28-day off treatment period.", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Tobramycin Inhalation Powder (TIP)", "OutcomeGroupDescription":"Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"157" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Day 29, Cycle 1 (n=149)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"10.3", "OutcomeMeasurementSpread":"36.05" } ] } } ] } },{ "OutcomeClassTitle":"Day 85, Cycle 2 (n=146)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"9.4", "OutcomeMeasurementSpread":"55.35" } ] } } ] } },{ "OutcomeClassTitle":"Day 141, Cycle 3 (n=128)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5.5", "OutcomeMeasurementSpread":"31.82" } ] } } ] } },{ "OutcomeClassTitle":"Day 197, Cycle 4 (n=116)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6.0", "OutcomeMeasurementSpread":"30.96" } ] } } ] } },{ "OutcomeClassTitle":"Day 253, Cycle 5 (n=105)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.9", "OutcomeMeasurementSpread":"33.23" } ] } } ] } },{ "OutcomeClassTitle":"Day 309, Cycle 6 (n=100)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4.3", "OutcomeMeasurementSpread":"32.44" } ] } } ] } },{ "OutcomeClassTitle":"Day 337, Completion (n=93)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.7", "OutcomeMeasurementSpread":"33.78" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in Pseudomonas Aeruginosa Colony Forming Units in Sputum", "OutcomeMeasureDescription":"Sputum was collected in sterile containers and cultured for Pseudomonas aeruginosa (Pa.) (quantitative test) and other typical Cystic Fibrosis respiratory pathogens. The Pa. biotypes measured were mucoid, dry and small colony variant. Results are presented for the sum of all biotypes of Pa, with data transformed using a base 10 logarithm.", "OutcomeMeasurePopulationDescription":"Participants from the safety set who had Pa sputum density values at both baseline and the given time point were included in the analysis. The safety set included all participants who received at least one dose of study drug.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"log10 Colony Forming Unit (CFU)", "OutcomeMeasureTimeFrame":"Baseline, day 1, day 29, day 85, day 141, day 197, day 253, day 309, day 337", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Tobramycin Inhalation Powder (TIP)", "OutcomeGroupDescription":"Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"157" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Sum of all biotypes, Day 29, Cycle 1 (n=141)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.6", "OutcomeMeasurementSpread":"2.28" } ] } } ] } },{ "OutcomeClassTitle":"Sum of all biotypes, Day 85, Cycle 2 (n=135)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.1", "OutcomeMeasurementSpread":"1.80" } ] } } ] } },{ "OutcomeClassTitle":"Sum of all biotypes, Day 141, Cycle 3 (n=119)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.2", "OutcomeMeasurementSpread":"1.98" } ] } } ] } },{ "OutcomeClassTitle":"Sum of all biotypes, Day 197, Cycle 4(n=107)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.1", "OutcomeMeasurementSpread":"2.11" } ] } } ] } },{ "OutcomeClassTitle":"Sum of all biotypes. Day 253, Cycle 5 (n=98)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.3", "OutcomeMeasurementSpread":"2.23" } ] } } ] } },{ "OutcomeClassTitle":"Sum of all biotypes, Day 309, Cycle 6 (n=89)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.2", "OutcomeMeasurementSpread":"2.09" } ] } } ] } },{ "OutcomeClassTitle":"Sum of all biotypes, Day 337, Completion (n=85)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.4", "OutcomeMeasurementSpread":"2.08" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Tobramycin MIC 50 and MIC 90 Values Over All Isolates for the Sum of All Biotypes (Mucoid, Dry and Small Colony Variant) of Pseudomonas Aeruginosa", "OutcomeMeasureDescription":"Tobramycin MIC 50 and MIC 90 values were defined as the lowest concentration of tobramycin required to inhibit 50% and 90%, respectively, of the P. aeruginosa strains tested.", "OutcomeMeasurePopulationDescription":"Participants from the safety set who had data at each time point/cycle were analyzed at each time point. The safety set included all participants who received at least one dose of study drug.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"ug/mL", "OutcomeMeasureTimeFrame":"Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Tobramycin Inhalation Powder (TIP)", "OutcomeGroupDescription":"Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy. Total number of isolates at each cycle/day: baseline = 279; cycle 1, day 29 = 252; cycle 2, day 85 = 238; cycle 3, day 141 = 210; cycle 4, day 197 = 184; cycle 5, day 253 = 178; cycle 6, day 309 = 164; and completion, day 337 = 158" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"157" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline - MIC 50 (n=156)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 1, day 29 - MIC 50 (n=144)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 2, day 85 - MIC 50 (n=137)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 3, day 141 - MIC 50 (n=124)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 4, day 197 - MIC 50 (n=108)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 5, day 253 - MIC 50 (n=98)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 6, day 309 - MIC 50 (n=90)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4" } ] } } ] } },{ "OutcomeClassTitle":"Completion, day 337 - MIC 50 (n=89)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" } ] } } ] } },{ "OutcomeClassTitle":"Baseline - MIC 90 (n=156)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"128" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 1, day 29 - MIC 90 (n=144)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"256" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 2, day 85 - MIC 90 (n=137)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"256" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 3, day 141 - MIC 90 (n=124)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"256" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 4, day 197 - MIC 90 (n=108)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"128" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 5, day 253 - MIC 90 (n=98)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"256" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 6, day 309 - MIC 90 (n=90)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"256" } ] } } ] } },{ "OutcomeClassTitle":"Completion, day 337 - MIC 90 (n=89)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"512" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants Hospitalized Due to Serious Respiratory-related Adverse Events", "OutcomeMeasurePopulationDescription":"Safety set: The safety set included all participants who received at least one dose of study drug.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"Day 337", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Tobramycin Inhalation Powder (TIP)", "OutcomeGroupDescription":"Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"157" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"26.8" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Hospitalization Days Due to Serious Respiratory-related Adverse Events", "OutcomeMeasureDescription":"The total number of hospitalization days due to serious respiratory-related adverse events was analyzed.", "OutcomeMeasurePopulationDescription":"Safety set: The safety set included all participants who received at least one dose of study drug.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"Days", "OutcomeMeasureTimeFrame":"Day 337", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Tobramycin Inhalation Powder (TIP)", "OutcomeGroupDescription":"Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"157" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"18.1", "OutcomeMeasurementSpread":"17.14" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Time to First Hospitalization Due to Serious Respiratory-related Adverse Events", "OutcomeMeasureDescription":"The day of first hospitalization due to serious respiratory-related adverse events was analyzed.", "OutcomeMeasurePopulationDescription":"Safety set The safety set included all participants who received at least one dose of study drug.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"Days", "OutcomeMeasureTimeFrame":"Day 337", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Tobramycin Inhalation Powder (TIP)", "OutcomeGroupDescription":"Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"157" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementLowerLimit":"NA", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"The median was not estimable due to an insufficient number of events." } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants Who Used New Anti-pseudomonal Antibiotics", "OutcomeMeasurePopulationDescription":"Safety set: The safety set included all participants who received at least one dose of study drug.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"Day 337", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Tobramycin Inhalation Powder (TIP)", "OutcomeGroupDescription":"Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"157" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"65.6" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Days of New Anti-pseudomonal Antibiotic Use", "OutcomeMeasureDescription":"The total number of days of new anti-pseudomonal antibiotic use was analyzed.", "OutcomeMeasurePopulationDescription":"Safety set: The safety set included all participants who received at least one dose of study drug.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"Days", "OutcomeMeasureTimeFrame":"Day 337", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Tobramycin Inhalation Powder (TIP)", "OutcomeGroupDescription":"Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"157" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"33.1", "OutcomeMeasurementSpread":"25.17" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Time to Use of New Anti-pseudomonal Antibiotic", "OutcomeMeasureDescription":"Time to first use of new anti-pseudomonal antibiotic was analyzed.", "OutcomeMeasurePopulationDescription":"Safety set The safety set included all participants who received at least one dose of study drug.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"Days", "OutcomeMeasureTimeFrame":"Day 337", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Tobramycin Inhalation Powder (TIP)", "OutcomeGroupDescription":"Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"157" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"136", "OutcomeMeasurementLowerLimit":"97", "OutcomeMeasurementUpperLimit":"170" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"3", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Tobramycin Inhalation Powder (TIP)", "EventGroupDescription":"Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). 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However, Novartis does not prohibit any investigator from publishing. 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