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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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.
Secondary ID [1] 0 0
CTBM100C2401E1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Long-term Safety of TIP 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Baseline (start of study treatment in core study) to Day 673 (end of the extension study)
Secondary outcome [1] 0 0
Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted Over 12 Treatment Cycles
Timepoint [1] 0 0
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)
Secondary outcome [2] 0 0
Absolute Change From Baseline in Pseudomonas Aeruginosa Sputum Density Over 12 Treatment Cycles
Timepoint [2] 0 0
Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day
Secondary outcome [3] 0 0
Tobramycin Minimum Inhibitory Concentration (MIC) 50 and MIC 90 Values for Pseudomonas Aeruginosa Over 12 Treatment Cycles
Timepoint [3] 0 0
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)
Secondary outcome [4] 0 0
Percentage of Participants Who Used New Anti-pseudomonal Antibiotics Over 12 Treatment Cycles
Timepoint [4] 0 0
Baseline of core study, Day 673 (end of the extension study)
Secondary outcome [5] 0 0
Total Number of Days of New Anti-pseudomonal Antibiotics Use Over 12 Treatment Cycles
Timepoint [5] 0 0
Baseline of core study, Day 673 (end of the extension study)
Secondary outcome [6] 0 0
Time to Use of New Anti-pseudomonal Antibiotics Over 12 Treatment Cycles
Timepoint [6] 0 0
Baseline of core study, Day 673 (end of the extension study)
Secondary outcome [7] 0 0
The Percentage of the Participants Hospitalized Due to Serious Respiratory-related AEs Were Determined During the Study.
Timepoint [7] 0 0
Baseline of core study, Day 673 (end of the extension study)
Secondary outcome [8] 0 0
Number of Hospitalization Days Due to Respiratory Related Serious Adverse Events (SAEs) Over 12 Treatment Cycles
Timepoint [8] 0 0
Baseline of core study, Day 673 (end of the extension study)
Secondary outcome [9] 0 0
Time to First Hospitalization Due to Respiratory Related Serious Adverse Events (SAEs) Over 12 Treatment Cycles
Timepoint [9] 0 0
Baseline of core study, Day 673 (end of the extension study)
Secondary outcome [10] 0 0
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
Timepoint [10] 0 0
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)
Secondary outcome [11] 0 0
Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted Over 6 Treatment Cycles in Extension Study
Timepoint [11] 0 0
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)
Secondary outcome [12] 0 0
Absolute Change From Baseline in Pseudomonas Aeruginosa Density Over 6 Treatment Cycles in Extension Study
Timepoint [12] 0 0
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)
Secondary outcome [13] 0 0
Percentage of Participants Who Used New Anti-pseudomonal Antibiotics in Extension Study
Timepoint [13] 0 0
Baseline of extension study, Day 673 (end of extension study)
Secondary outcome [14] 0 0
Total Number of Days of New Anti-pseudomonal Antibiotics Use in Extension Study
Timepoint [14] 0 0
Baseline of extension study, Day 673 (end of extension study)
Secondary outcome [15] 0 0
Time to Use of New Anti-pseudomonal Antibiotics in Extension Study
Timepoint [15] 0 0
Baseline of extension study, Day 673 (end of extension study)
Secondary outcome [16] 0 0
Percentage of Participants Hospitalized Due to Respiratory Related Serious Adverse Events (SAEs) in Extension Study
Timepoint [16] 0 0
Baseline of extension study, Day 673 (end of the extension study)
Secondary outcome [17] 0 0
Number of Hospitalization Days Due to Respiratory Related Serious Adverse Events (SAEs) in Extension Study
Timepoint [17] 0 0
Baseline of extension study, Day 673 (end of extension study)
Secondary outcome [18] 0 0
Time to First Hospitalization Due to Respiratory Related Serious Adverse Events (SAEs) in Extension Study
Timepoint [18] 0 0
Baseline of extension study, Day 673 (end of extension study)
Secondary outcome [19] 0 0
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
Timepoint [19] 0 0
Baseline (start of study treatment in extension study) to Day 673 (end of the extension study)

Eligibility
Key inclusion criteria
* Completion of the core study CTBM100C2401 and able to comply with all protocol requirements of the extension study
Minimum age
6 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2014
Sample size
Target
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - New Lambton Heights
Recruitment hospital [2] 0 0
Novartis Investigative Site - Parkville
Recruitment postcode(s) [1] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [2] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Ohio
Country [2] 0 0
United States of America
State/province [2] 0 0
South Carolina
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
Argentina
State/province [4] 0 0
Buenos Aires
Country [5] 0 0
Argentina
State/province [5] 0 0
Cordoba
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec
Country [7] 0 0
Germany
State/province [7] 0 0
Essen
Country [8] 0 0
Hungary
State/province [8] 0 0
Budapest
Country [9] 0 0
Italy
State/province [9] 0 0
FI
Country [10] 0 0
Italy
State/province [10] 0 0
ME
Country [11] 0 0
Italy
State/province [11] 0 0
VR
Country [12] 0 0
Italy
State/province [12] 0 0
Palermo
Country [13] 0 0
Italy
State/province [13] 0 0
Roma
Country [14] 0 0
Mexico
State/province [14] 0 0
Distrito Federal
Country [15] 0 0
Mexico
State/province [15] 0 0
Nuevo León
Country [16] 0 0
Spain
State/province [16] 0 0
Catalunya
Country [17] 0 0
Spain
State/province [17] 0 0
Comunidad Valenciana

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01775137
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01775137