patients with cystic fibrosis and chronical infection with Pseudomonas aeruginosa MedDRA version: 9.1 Level: LLT Classification code 10011763 Term: Cystic fibrosis lung
Conditions
Interventions
Trade Name: Tobi
Product Name: Tobi
Product Code: TBM100
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: Tobramycin
CAS Number: 32986-56-4
Current Sponsor code: TBM100
Concentration unit:
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects aged =6 years at the time of screening, with an Informed Consent Form signed by patient and if appropriate by parent/legal guardians, prior to any study-related procedure. 2. Confirmed diagnosis of CF by the presence of one or more clinical features of CF in addition to a quantitative pilocarpine iontophoresis sweat chloride test of >60 mEq/L; or identification of well-characterized disease-causing mutations in each CFTR gene; or an abnormal nasal transepithelial potential difference characteristic of CF. 3. P. aeruginosa must be present in sputum or deep throat swab (or bronchoalveolar lavage [BAL]) at the screening visit and within 6 months prior to screening. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of sputum (or BAL) culture yielding Burkholderia cepacia (B. cepacia) within 2 years prior to screening and/or sputum culture yielding B cepacia at screening. 2. FEV1 5 mIU/ml)) o who are menstruating and capable of becoming pregnant* and not practicing a medically approved method of contraception (Pearl Index 40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy **examples of particularly reliable methods with Pearl Index (PI) <1, according to guidelines of Deutsche Gesellschaft für Gynäkologie und Geburtshilfe: - Combination pill with estrogen and gestagen (no mini-pill, PI=0.1-0.9) - Vaginal ring (NuvaRing®, PI=0.65 uncorr.; 0.4 corr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the serum pharmacokinetics (PK) of inhaled TOBI® (AUC0-90’) of continuous daily dosing regimens with 2x300mg/d Tobramycin Nebulised Solution (=TNS) inhaled with the PARI eFlow® rapid in Cystic Fibrosis (CF) subjects.;Secondary Objective: • To evaluate the serum pharmacokinetics (PK) of inhaled TOBI® (AUC0-90’) of continuous daily dosing regimens with 1x300mg/d Tobramycin Nebulised Solution (=TNS) inhaled with the PARI eFlow® rapid in Cystic Fibrosis (CF) subjects. • To compare the serum PK of inhaled TOBI® (trough-/peak-level) of both dosing regimens in Cystic Fibrosis (CF) Subjects with a FEV1=80% vs. CF-Subjects with a FEV1<80%. • To evaluate the change of MIC of P. aeruginosa during a continuous treatment with 1x300mg/d and 2x300mg/d TNS. • To assess the safety of a continuous daily dosing regimen with 1x300mg/d and 2x300mg/d TNS over 8 weeks, compared to historic safety data of the 4 week on/off dosing regimen with 2x300mg/d. ;Primary end point(s): The primary variable is the serum tobramycin AUC0-90’. | — |
Countries
Germany
Outcome results
None listed