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

Purpose

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.

Condition	Intervention	Phase
Long-term Safety of TIP	Drug: TBM100	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label
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.

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Incidence of treatment emergent adverse events in 2 years [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Safety of TIP measured in terms of total number of treatment emergent adverse events (including the core and extension periods)

Secondary Outcome Measures:

Relative change in predicted FEV1 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Change in relative predicted Forced Expiratory Volume in one second (FEV1) across 12 cycles of TIP treatment, from baseline to the end of the dosing periods
Absolute change in predicted FEV1 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Change in predicted absolute Forced Expiratory Volume in one second (FEV1) across 12 cycles of TIP treatment, from baseline to the end of the dosing periods
Acute changes in FEV1 percent predicted [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Acute changes in Forced Expiratory Volume in one second (FEV1) predicted percent from pre-dose to 30 min post-dose by visit, across 12 cycles of TIP treatment from baseline to the end of dosing periods
Absolute change in P.aeruginosa sputum density [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Absolute change measured via P. aeruginosa sputum density by biotype, across 12 cycles of TIP treatment from baseline to the end of the dosing period
P.aeruginosa tobramycin MIC change [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Change in terms of P.aeruginosa tobramycin Minimal inhibitory capacity across 12 cycles of TIP treatment from baseline to the end of dosing period
Number of hospitalizations due to serious respiratory related AEs [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Total number of hospitalizations due to serious respiratory related adverse events across 12 cycles of TIP treatment from baseline to the end of dosing periods
Usage of anti-pseudomonal antibiotics [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Usage of (overall, oral, intravenous) anti-pseudomonal antibiotics across 12 cycles of TIP treatment from baseline to the end of dosing period
clinical laboratory and audiology results [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Safety (lab & audiology) profile of TIP by visit across 12 cycles of TIP treatment from baseline to the end of dosing periods
Relative change in predicted FEV1 during extension period [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Change in relative predicted Forced Expiratory Volume in one second (FEV1) during the extension period only
Absolute change in predicted FEV1 during extension period [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Change in predicted absolute Forced Expiratory Volume in one second (FEV1) during the extension period only
Acute changes in FEV1 percent predicted during the extension period [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Acute changes in Forced Expiratory Volume in one second (FEV1) predicted percent from pre-dose to 30 min post-dose by visit during the extension period only
Absolute change in P.aeruginosa sputum density during the extension period [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Absolute change measured via P. aeruginosa sputum density by biotype during the extension period only
P.aeruginosa tobramycin MIC change during the extension period [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Change in terms of P.aeruginosa tobramycin Minimal inhibitory capacity during the extension period only
Number of hospitalizations due to serious respiratory related AEs during the extension [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Total number of hospitalizations due to serious respiratory related adverse events during the extension period only
clinical laboratory and audiology results during the extension period [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Safety (lab & audiology) profile of TIP by visit during the extension period only
Usage of anti-pseudomonal antibiotics [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Usage of (overall, oral, intravenous) anti-pseudomonal antibiotics during the extension period only
Incidence of treatment emergent adverse events for the extension study only [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Safety of TIP measured in terms of total number of treatment emergent adverse events during the extension period only

Estimated Enrollment:	120
Study Start Date:	February 2013
Estimated Study Completion Date:	November 2014
Estimated Primary Completion Date:	November 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: TBM100 TIP 112 mg/b.i.d	Drug: TBM100 Tobramycin inhalation powder (TIP) 112mg/b.i.d

Eligibility

Ages Eligible for Study:	6 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01775137

Contacts

Contact: Novartis Pharmaceuticals	1-888-669-6682
Contact: Novartis Pharmaceuticals

Show 40 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01775137 History of Changes
Other Study ID Numbers:	CTBM100C2401E1
Study First Received:	January 22, 2013
Last Updated:	March 20, 2013
Health Authority:	Hungary: Gyógyszerészeti és Egészségügyi Minőség- és Szervezetfejlesztési Intézet Australia:Therapeutic Goods Administration Italy: Italian Medicines Agency (AIFA) Germany: BfArM - Bundesinstitut fuer Arzneimittel und Medizinprodukte Mexico: Comisión Federal para la Protección Contra Riesgos Sanitarios Argentina: Administración Nacional de Medicamentos Alimentos y Tecnología Medica Spain: Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) United States: Food and Drug Administration Canada: Health Canada

Keywords provided by Novartis:

CF, Open-label, TIP, phase IV, extension study

ClinicalTrials.gov processed this record on June 18, 2013