Ext. Long-term Safety Study in CF Patients: Single Arm TIP

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01775137
• Date of registration: 22/01/2013
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• 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.
• Date of first enrolment: February 2013
• Target sample size: 45
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01775137
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

Argentina, Australia, Canada, Germany, Hungary, Italy, Mexico, Spain, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria:

- Completion of the core study CTBM100C2401 and able to comply with all protocol
requirements of the extension study

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



Age minimum: 6 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Long-term Safety of TIP

Intervention(s)

Drug: TBM100

Primary Outcome(s)

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 [Time Frame: Baseline (start of study treatment in core study) to Day 673 (end of the extension study)]

Secondary Outcome(s)

Number of Hospitalization Days Due to Respiratory Related Serious Adverse Events (SAEs) Over 12 Treatment Cycles [Time Frame: Baseline of core study, Day 673 (end of the extension study)]

Percentage of Participants Hospitalized Due to Respiratory Related Serious Adverse Events (SAEs) in Extension Study [Time Frame: Baseline of extension study, Day 673 (end of the extension study)]

Time to First Hospitalization Due to Respiratory Related Serious Adverse Events (SAEs) Over 12 Treatment Cycles [Time Frame: Baseline of core study, Day 673 (end of the extension study)]

Absolute Change From Baseline in Pseudomonas Aeruginosa Density Over 6 Treatment Cycles in Extension Study [Time Frame: 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)]

Percentage of Participants Who Used New Anti-pseudomonal Antibiotics in Extension Study [Time Frame: Baseline of extension study, Day 673 (end of extension study)]

Time to First Hospitalization Due to Respiratory Related Serious Adverse Events (SAEs) in Extension Study [Time Frame: Baseline of extension study, Day 673 (end of extension study)]

Total Number of Days of New Anti-pseudomonal Antibiotics Use in Extension Study [Time Frame: Baseline of extension study, Day 673 (end of extension study)]

Total Number of Days of New Anti-pseudomonal Antibiotics Use Over 12 Treatment Cycles [Time Frame: Baseline of core study, Day 673 (end of the extension study)]

Absolute Change From Baseline in Pseudomonas Aeruginosa Sputum Density Over 12 Treatment Cycles [Time Frame: Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day]

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 [Time Frame: 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)]

The Percentage of the Participants Hospitalized Due to Serious Respiratory-related AEs Were Determined During the Study. [Time Frame: Baseline of core study, Day 673 (end of the extension study)]

Percentage of Participants Who Used New Anti-pseudomonal Antibiotics Over 12 Treatment Cycles [Time Frame: Baseline of core study, Day 673 (end of the extension study)]

Number of Hospitalization Days Due to Respiratory Related Serious Adverse Events (SAEs) in Extension Study [Time Frame: Baseline of extension study, Day 673 (end of extension study)]

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 [Time Frame: Baseline (start of study treatment in extension study) to Day 673 (end of the extension study)]

Time to Use of New Anti-pseudomonal Antibiotics in Extension Study [Time Frame: Baseline of extension study, Day 673 (end of extension study)]

Tobramycin Minimum Inhibitory Concentration (MIC) 50 and MIC 90 Values for Pseudomonas Aeruginosa Over 12 Treatment Cycles [Time Frame: 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)]

Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted Over 12 Treatment Cycles [Time Frame: 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)]

Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted Over 6 Treatment Cycles in Extension Study [Time Frame: 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)]

Time to Use of New Anti-pseudomonal Antibiotics Over 12 Treatment Cycles [Time Frame: Baseline of core study, Day 673 (end of the extension study)]

Secondary ID(s)

CTBM100C2401E1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/11/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01775137