An extension of a clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis

A 48 week extension to CTBM100C2401, a single arm open-label, multicenter, phase IV trial, to assess long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003532-23-HU

Enrollment

120

Registered

2012-10-31

Start date

2012-12-19

Completion date

Unknown

Last updated

2015-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients MedDRA version: 14.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1 Level: LLT Classification code 10021860 Term: Infection pseudomonas aeruginosa System Organ Class: 100000004862

Interventions

Trade Name: TOBI Podhaler Product Name: TOBI Podhaler Product Code: TBM100C Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: Tobramycin CAS Number: 32986-56-4 Current Sponsor

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Provide written informed consent, HIPAA (Health Insurance Portability and Accountability Act) authorization (where applicable), and assent (as appropriate) prior to the performance of any study-related procedure. 2. Completed the core study CTBM100C2401 and able to comply with all protocol requirements of the extension study. Are the trial subjects under 18? yes Number of subjects for this age range: 25 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 93 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2

Exclusion criteria

Exclusion criteria: 1. Serum creatinine 2mg/dl or more, BUN 40mg/dl or more, or an abnormal urinalysis defined as 2+ or greater proteinuria at entry into the extension study (visit 15). 2. Use of loop diuretics within 7 days prior to entry into the extension study. 3. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive HCG laboratory test (> 5 mIU/mL) at Visit 15. 4. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using a highly effective method of contraception during dosing of study treatment as defined in full protocol.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the safety of Tobramycin Inhalation Powder (TIP) across 12 treatment cycles (6 treatment cycles in the core study and 6 treatment cycles in the extension study) in terms of the incidence of treatment emergent adverse events (AEs).;Secondary Objective: To evaluate endpoints of interest across 12 cycles (6 treatment cycles in the core study and 6 treatment cycles in the extension study) of TIP treatment: • change in FEV1 % predicted (relative and absolute) • absolute change in P. aeruginosa CFU per gram of sputum • change of P. aeruginosa tobramycin MIC • time to first and the rate of the usage (overall, oral, intravenous) of antipseudomonal antibiotic (other than those regularly scheduled as prophylactic treatment) • time to first and the rate of hospitalization due to serious respiratory-related AEs • safety profile of TIP in terms of clinical laboratory results and audiology (in a sub-set of patients) • safety profile of TIP in terms of acute change in FEV1 from pre-dose to 30 minutes post dose • To evaluate the above endpoints of interest (including the primary endpoint of incidence of AEs) across the 6 cycles of treatment in this extension study.;Primary end point(s): Incidence of treatment-emergent adverse event;Timepoint(s) of evaluation of this end point: Across 12 cycles of treatment (core study and extension) and within the extension alone	—

Measure

Time frame

Main Objective: To assess the safety of Tobramycin Inhalation Powder (TIP) across 12 treatment cycles (6 treatment cycles in the core study and 6 treatment cycles in the extension study) in terms of the incidence of treatment emergent adverse events (AEs).;Secondary Objective: To evaluate endpoints of interest across 12 cycles (6 treatment cycles in the core study and 6 treatment cycles in the extension study) of TIP treatment: • change in FEV1 % predicted (relative and absolute) • absolute change in P. aeruginosa CFU per gram of sputum • change of P. aeruginosa tobramycin MIC • time to first and the rate of the usage (overall, oral, intravenous) of antipseudomonal antibiotic (other than those regularly scheduled as prophylactic treatment) • time to first and the rate of hospitalization due to serious respiratory-related AEs • safety profile of TIP in terms of clinical laboratory results and audiology (in a sub-set of patients) • safety profile of TIP in terms of acute change in FEV1 from pre-dose to 30 minutes post dose • To evaluate the above endpoints of interest (including the primary endpoint of incidence of AEs) across the 6 cycles of treatment in this extension study.;Primary end point(s): Incidence of treatment-emergent adverse event;Timepoint(s) of evaluation of this end point: Across 12 cycles of treatment (core study and extension) and within the extension alone

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Secondary

Measure	Time frame
Secondary end point(s): 1) Relative change in FEV1% predicted, FVC % predicted and FEF25-75 % predicted from baseline 2) Relative change in P aeruginosa CFU in sputum from baseline 3) Change in P aeruginosa tobramycin MIC from baseline 4) Rate of and time to the first hospitalization due to serious respiratory-related AE 5) Rate of and time to the first use of anti-pseudomonal antibiotics (overall, oral, intravenous) 6) Acute change in FEV1% predicted from pre-dose to post-dose 30 minutes 7) Evaluation of clinical laboratory results and (in selected study sites) audiology;Timepoint(s) of evaluation of this end point: 1) Visits 15 (baseline of extension), 16, 18, 20, 22, 24, 26, 27 2) Visits 15 (baseline of extension), 16, 18, 20, 22, 24, 26, 27 3) Visits 15 (baseline of extension), 16, 18, 20, 22, 24, 26, 27 4) across 12 cycles of treatment (core study and extension) and within the extension alone 5) across 12 cycles of treatment (core study and extension) and within the extension alone 6) Visits 16, 18, 20, 22, 24, 26 7) Evaluation of clinical laboratory results and (in selected study sites) audiology: across 12 cycles of treatment (core study and extension) and within the extension alone	—

Measure

Time frame

Secondary end point(s): 1) Relative change in FEV1% predicted, FVC % predicted and FEF25-75 % predicted from baseline 2) Relative change in P aeruginosa CFU in sputum from baseline 3) Change in P aeruginosa tobramycin MIC from baseline 4) Rate of and time to the first hospitalization due to serious respiratory-related AE 5) Rate of and time to the first use of anti-pseudomonal antibiotics (overall, oral, intravenous) 6) Acute change in FEV1% predicted from pre-dose to post-dose 30 minutes 7) Evaluation of clinical laboratory results and (in selected study sites) audiology;Timepoint(s) of evaluation of this end point: 1) Visits 15 (baseline of extension), 16, 18, 20, 22, 24, 26, 27 2) Visits 15 (baseline of extension), 16, 18, 20, 22, 24, 26, 27 3) Visits 15 (baseline of extension), 16, 18, 20, 22, 24, 26, 27 4) across 12 cycles of treatment (core study and extension) and within the extension alone 5) across 12 cycles of treatment (core study and extension) and within the extension alone 6) Visits 16, 18, 20, 22, 24, 26 7) Evaluation of clinical laboratory results and (in selected study sites) audiology: across 12 cycles of treatment (core study and extension) and within the extension alone

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Countries

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

Contacts

Public ContactPublic Information Desk

Novartis Hungária Kft., Pharma

infoph.hungary@novartis.com+361457-6500

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026