Clinical trial NCT01775137: Ext. Long-term Safety Study in CF Patients: Single Arm TIP
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Long-term Safety of TIP
Keywords: CF, Open-label, TIP, phase IV, extension study
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-01-24
Enrollment: 45
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Baseline (start of study treatment in core study) to Day 673 (end of the extension study)
Secondary outcomes:
measure: Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted Over 12 Treatment Cycles
timeFrame: 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)
measure: Absolute Change From Baseline in Pseudomonas Aeruginosa Sputum Density Over 12 Treatment Cycles
timeFrame: Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day
measure: Tobramycin Minimum Inhibitory Concentration (MIC) 50 and MIC 90 Values for Pseudomonas Aeruginosa Over 12 Treatment Cycles
timeFrame: 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)
measure: Percentage of Participants Who Used New Anti-pseudomonal Antibiotics Over 12 Treatment Cycles
timeFrame: Baseline of core study, Day 673 (end of the extension study)
measure: Total Number of Days of New Anti-pseudomonal Antibiotics Use Over 12 Treatment Cycles
timeFrame: Baseline of core study, Day 673 (end of the extension study)
measure: Time to Use of New Anti-pseudomonal Antibiotics Over 12 Treatment Cycles
timeFrame: Baseline of core study, Day 673 (end of the extension study)
measure: The Percentage of the Participants Hospitalized Due to Serious Respiratory-related AEs Were Determined During the Study.
timeFrame: Baseline of core study, Day 673 (end of the extension study)
measure: Number of Hospitalization Days Due to Respiratory Related Serious Adverse Events (SAEs) Over 12 Treatment Cycles
timeFrame: Baseline of core study, Day 673 (end of the extension study)
measure: Time to First Hospitalization Due to Respiratory Related Serious Adverse Events (SAEs) Over 12 Treatment Cycles
timeFrame: Baseline of core study, Day 673 (end of the extension study)
measure: 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
timeFrame: 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)
measure: Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted Over 6 Treatment Cycles in Extension Study
timeFrame: 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)
measure: Absolute Change From Baseline in Pseudomonas Aeruginosa Density Over 6 Treatment Cycles in Extension Study
timeFrame: 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)
measure: Percentage of Participants Who Used New Anti-pseudomonal Antibiotics in Extension Study
timeFrame: Baseline of extension study, Day 673 (end of extension study)
measure: Total Number of Days of New Anti-pseudomonal Antibiotics Use in Extension Study
timeFrame: Baseline of extension study, Day 673 (end of extension study)
measure: Time to Use of New Anti-pseudomonal Antibiotics in Extension Study
timeFrame: Baseline of extension study, Day 673 (end of extension study)
measure: Percentage of Participants Hospitalized Due to Respiratory Related Serious Adverse Events (SAEs) in Extension Study
timeFrame: Baseline of extension study, Day 673 (end of the extension study)
measure: Number of Hospitalization Days Due to Respiratory Related Serious Adverse Events (SAEs) in Extension Study
timeFrame: Baseline of extension study, Day 673 (end of extension study)
measure: Time to First Hospitalization Due to Respiratory Related Serious Adverse Events (SAEs) in Extension Study
timeFrame: Baseline of extension study, Day 673 (end of extension study)
measure: 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
timeFrame: Baseline (start of study treatment in extension study) to Day 673 (end of the extension study)
Other outcomes:
Locations:
city: Akron
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Charleston
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Capital Federal
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Córdoba
country: Argentina
facility: Novartis Investigative Site
state: Cordoba
city: New Lambton Heights
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Parkville
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Firenze
country: Italy
facility: Novartis Investigative Site
state: FI
city: Messina
country: Italy
facility: Novartis Investigative Site
state: ME
city: Verona
country: Italy
facility: Novartis Investigative Site
state: VR
city: Palermo
country: Italy
facility: Novartis Investigative Site
city: Roma
country: Italy
facility: Novartis Investigative Site
city: Mexico
country: Mexico
facility: Novartis Investigative Site
state: Distrito Federal
city: Monterrey
country: Mexico
facility: Novartis Investigative Site
state: Nuevo León
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: