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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01775137
Registration number
NCT01775137
Ethics application status
Date submitted
22/01/2013
Date registered
24/01/2013
Date last updated
6/11/2015
Titles & IDs
Public title
Ext. Long-term Safety Study in CF Patients: Single Arm TIP
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Scientific title
A 48 Week Extension to CTBM100C2401, a Single Arm, Open-label, Multicenter, Phase IV Extension Trial to Assess Long Term Safety of Tobramycin Inhalation Powder (TIP) in Patients With Cystic Fibrosis Who Completed Participation in CTBM100C2401.
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Secondary ID [1]
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CTBM100C2401E1
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Long-term Safety of TIP
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - TBM100
Experimental: TBM100 - TIP 112 mg/b.i.d
Treatment: Drugs: TBM100
Tobramycin inhalation powder (TIP) 112mg/b.i.d
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs/SAEs Leading to Discontinuation of Study Drug and Deaths Over 12 Treatment Cycles
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Assessment method [1]
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An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes. Based on the severity, AEs were categorised into 3 types as mild, moderate and severe. Death was a fatal event leading to permanent cessations of all vital functions of the body.
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Timepoint [1]
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Baseline (start of study treatment in core study) to Day 673 (end of the extension study)
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Secondary outcome [1]
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Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted Over 12 Treatment Cycles
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Assessment method [1]
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FEV1 was defined as the volume of air expired in 1 second. FEV1 was assessed as a pulmonary function by using spirometry tests in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) criteria. FEV1% predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant's age, gender and height. Relative change in FEV1 % predicted from baseline to pre-dose day X = ((pre-dose day*FEV1% predicted - baseline FEV1% predicted) / baseline FEV1 % predicted) x 100.
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Timepoint [1]
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Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study)
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Secondary outcome [2]
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Absolute Change From Baseline in Pseudomonas Aeruginosa Sputum Density Over 12 Treatment Cycles
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Assessment method [2]
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Microbiological data was collected to understand the direct impact of the drug on the pathogens. Sputum samples were cultured for the presence of three Pseudomonas aeruginosa (P. aeruginosa) biotypes measured were mucoid, dry and small colony variant. Absolute change was determined using the formula = (Post-baseline value- baseline value). If no P. aeruginosa was isolated for a visit, log10 colony forming units (CFU) was imputed with log10 (19) for all biotypes.
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Timepoint [2]
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Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day
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Secondary outcome [3]
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Tobramycin Minimum Inhibitory Concentration (MIC) 50 and MIC 90 Values for Pseudomonas Aeruginosa Over 12 Treatment Cycles
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Assessment method [3]
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MIC was defined as the lowest concentration of an antimicrobial agent required to inhibit the visible growth of a microorganism after overnight incubation. 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 (mucoid,dry and small colony variant biotypes).
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Timepoint [3]
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Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study)
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Secondary outcome [4]
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Percentage of Participants Who Used New Anti-pseudomonal Antibiotics Over 12 Treatment Cycles
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Assessment method [4]
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The rate of anti-pseudomonal antibiotics use were determined from the collection of concomitant medication during the study.
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Timepoint [4]
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Baseline of core study, Day 673 (end of the extension study)
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Secondary outcome [5]
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Total Number of Days of New Anti-pseudomonal Antibiotics Use Over 12 Treatment Cycles
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Assessment method [5]
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The total number of days with usage of new anti-pseudomonal antibiotic were determined.
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Timepoint [5]
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Baseline of core study, Day 673 (end of the extension study)
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Secondary outcome [6]
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Time to Use of New Anti-pseudomonal Antibiotics Over 12 Treatment Cycles
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Assessment method [6]
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Time to first usage of anti-pseudomonal antibiotic was determined using Kaplan Meier estimate. Participants without an event were censored at the date of the last available post-baseline measurement.
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Timepoint [6]
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Baseline of core study, Day 673 (end of the extension study)
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Secondary outcome [7]
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The Percentage of the Participants Hospitalized Due to Serious Respiratory-related AEs Were Determined During the Study.
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Assessment method [7]
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The percentage of the participants hospitalized due to serious respiratory-related AEs were determined during the study.
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Timepoint [7]
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Baseline of core study, Day 673 (end of the extension study)
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Secondary outcome [8]
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Number of Hospitalization Days Due to Respiratory Related Serious Adverse Events (SAEs) Over 12 Treatment Cycles
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Assessment method [8]
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The total number of hospitalization days due to serious respiratory-related adverse events was analyzed using Kaplan-Meier estimate.
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Timepoint [8]
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Baseline of core study, Day 673 (end of the extension study)
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Secondary outcome [9]
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Time to First Hospitalization Due to Respiratory Related Serious Adverse Events (SAEs) Over 12 Treatment Cycles
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Assessment method [9]
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The day of first hospitalization due to serious respiratory-related adverse events was analysed using Kaplan Meier estimate.
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Timepoint [9]
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Baseline of core study, Day 673 (end of the extension study)
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Secondary outcome [10]
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Acute Relative Change From Pre-dose to 30-minute Post-dose in Forced Expiratory Volume in One Second (FEV1) Percent Predicted Over 12 Treatment Cycles
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Assessment method [10]
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FEV1 was defined as the volume of air expired in 1 second. FEV1 was assessed as a pulmonary function by using spirometry tests in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) criteria. Relative change in FEV1 % predicted was calculated by using the formula = 100 *(30-min post-dose value - pre-dose value) / pre-dose value.
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Timepoint [10]
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Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study)
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Secondary outcome [11]
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Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted Over 6 Treatment Cycles in Extension Study
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Assessment method [11]
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FEV1 was defined as the volume of air expired in 1 second. FEV1 was assessed as a pulmonary function by using spirometry tests in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) criteria. FEV1% predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant's age, gender and height. Relative change in FEV1 % predicted from baseline to pre-dose day X = ((pre-dose day*FEV1% predicted - baseline FEV1% predicted) / baseline FEV1 % predicted) x 100.
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Timepoint [11]
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Baseline (start of study treatment in extension study), Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study)
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Secondary outcome [12]
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Absolute Change From Baseline in Pseudomonas Aeruginosa Density Over 6 Treatment Cycles in Extension Study
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Assessment method [12]
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Microbiological data was collected to understand the direct impact of the drug on the pathogens. Sputum samples were cultured for the presence of three Pseudomonas aeruginosa (P. aeruginosa) biotypes measured were mucoid, dry and small colony variant. If no P. aeruginosa was isolated for a visit, log10 colony forming units (CFU) was imputed with log10 (19) for all biotypes. Absolute change was calculated by using the formula = (Value at actual time point - start of extension value).
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Timepoint [12]
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Baseline (start of study treatment in extension study), Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study)
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Secondary outcome [13]
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Percentage of Participants Who Used New Anti-pseudomonal Antibiotics in Extension Study
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Assessment method [13]
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The rate of anti-pseudomonal antibiotics use were determined from the collection of concomitant medication during the study.
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Timepoint [13]
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Baseline of extension study, Day 673 (end of extension study)
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Secondary outcome [14]
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Total Number of Days of New Anti-pseudomonal Antibiotics Use in Extension Study
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Assessment method [14]
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The total number of days with usage of new anti-pseudomonal antibiotic were determined.
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Timepoint [14]
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Baseline of extension study, Day 673 (end of extension study)
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Secondary outcome [15]
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Time to Use of New Anti-pseudomonal Antibiotics in Extension Study
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Assessment method [15]
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Time to first usage of anti-pseudomonal antibiotic was determined using Kaplan Meier estimate. Participants without an event were censored at the date of the last available post-baseline measurement.
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Timepoint [15]
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Baseline of extension study, Day 673 (end of extension study)
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Secondary outcome [16]
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Percentage of Participants Hospitalized Due to Respiratory Related Serious Adverse Events (SAEs) in Extension Study
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Assessment method [16]
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The percentage of the participants hospitalized due to serious respiratory-related AEs were determined during the extension study.
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Timepoint [16]
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Baseline of extension study, Day 673 (end of the extension study)
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Secondary outcome [17]
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Number of Hospitalization Days Due to Respiratory Related Serious Adverse Events (SAEs) in Extension Study
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Assessment method [17]
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The total number of hospitalisation days due to serious respiratory-related adverse events was analysed using Kaplan-Meier estimate.
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Timepoint [17]
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Baseline of extension study, Day 673 (end of extension study)
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Secondary outcome [18]
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Time to First Hospitalization Due to Respiratory Related Serious Adverse Events (SAEs) in Extension Study
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Assessment method [18]
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The day of first hospitalization due to serious respiratory related adverse events was analysed using Kaplan Meier estimate.
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Timepoint [18]
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Baseline of extension study, Day 673 (end of extension study)
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Secondary outcome [19]
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Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs/SAEs Leading to Discontinuation of Study Drug and Deaths Over 6 Treatment Cycles in Extension Study
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Assessment method [19]
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An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalisation, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes. Death was a fatal event leading to permanent cessations of all vital functions of the body.
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Timepoint [19]
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Baseline (start of study treatment in extension study) to Day 673 (end of the extension study)
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Eligibility
Key inclusion criteria
- Completion of the core study CTBM100C2401 and able to comply with all protocol
requirements of the extension study
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Minimum age
6
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Serum creatinine 2mg/dl, BUN 40mg/dl or proteinuria 2+ or more at the time of entry
into the extension
- Use of loop diuretics within 7 days prior to entry into the extension study
- Pregnant or nursing women
- Women of child bearing potential unless using highly effective method of contraception
as indicated in the protoco
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Study design
Purpose of the study
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2014
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Sample size
Target
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Accrual to date
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Final
45
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Novartis Investigative Site - New Lambton Heights
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Recruitment hospital [2]
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Novartis Investigative Site - Parkville
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Recruitment postcode(s) [1]
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2305 - New Lambton Heights
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Recruitment postcode(s) [2]
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3052 - Parkville
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Ohio
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Country [2]
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United States of America
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State/province [2]
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South Carolina
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Country [3]
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United States of America
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State/province [3]
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Texas
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Country [4]
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Argentina
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State/province [4]
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Buenos Aires
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Country [5]
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Argentina
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State/province [5]
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Cordoba
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Country [6]
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Canada
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State/province [6]
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Quebec
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Country [7]
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Germany
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State/province [7]
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Essen
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Country [8]
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Hungary
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State/province [8]
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Budapest
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Country [9]
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Italy
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State/province [9]
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FI
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Country [10]
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Italy
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State/province [10]
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ME
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Country [11]
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Italy
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State/province [11]
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VR
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Country [12]
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Italy
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State/province [12]
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Palermo
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Country [13]
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Italy
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State/province [13]
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Roma
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Country [14]
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Mexico
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State/province [14]
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Distrito Federal
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Country [15]
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Mexico
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State/province [15]
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Nuevo León
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Country [16]
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Spain
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State/province [16]
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Catalunya
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Country [17]
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Spain
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State/province [17]
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Comunidad Valenciana
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this extension study is to collect additional 48 weeks of safety data from
patients taking TIP who have completed the core study CTBM100C2401. The purpose of collecting
second year safety data through this study is to obtain long-term (2 years) safety data of
TIP.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01775137
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01775137
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