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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01775137
First received: January 22, 2013
Last updated: October 3, 2014
Last verified: October 2014
  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:


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: 86
Study Start Date: February 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Ohio
Novartis Investigative Site
Akron, Ohio, United States, 44308
United States, South Carolina
Novartis Investigative Site
Charleston, South Carolina, United States, 29425
United States, Texas
Novartis Investigative Site
Dallas, Texas, United States, 75230
Novartis Investigative Site
Houston, Texas, United States, 77030
Argentina
Novartis Investigative Site
Caba, Buenos Aires, Argentina, C1425DTG
Novartis Investigative Site
Capital Federal, Buenos Aires, Argentina, C1425EFD
Novartis Investigative Site
Córdoba, Cordoba, Argentina, X5014AKN
Australia, New South Wales
Novartis Investigative Site
New Lambton Heights, New South Wales, Australia, 2305
Australia, Victoria
Novartis Investigative Site
Parkville, Victoria, Australia, 3052
Canada, Quebec
Novartis Investigative Site
Montreal, Quebec, Canada, H3T1C5
Germany
Novartis Investigative Site
Essen, Germany, 45147
Hungary
Novartis Investigative Site
Budapest, Hungary, 1121
Italy
Novartis Investigative Site
Firenze, FI, Italy, 50139
Novartis Investigative Site
Messina, ME, Italy, 98125
Novartis Investigative Site
Verona, VR, Italy, 37126
Novartis Investigative Site
Palermo, Italy, 90100
Novartis Investigative Site
Roma, Italy, 00161
Mexico
Novartis Investigative Site
Mexico, Distrito Federal, Mexico, 06720
Novartis Investigative Site
Monterrey, Nuevo León, Mexico, 64460
Spain
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site
Valencia, Comunidad Valenciana, Spain, 46026
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals 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: October 3, 2014
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 October 16, 2014