Cystic fibrosis MedDRA version: 14.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders
Conditions
Interventions
Trade Name: Bramitob
Product Name: Bramitob
Product Code: 033841
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: TOBRAMYCIN
CAS Number: 32986-56-4
Current Sponsor code: TONI-2012
Concen
Sponsors
Erasmus University Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The criteria of inclusion will be the following: • Clinical diagnosis of CF and a positive sweat test or two CF-related mutations; • Either: early PA infection or colonization with PA requiring eradication with inhaled tobramycin, or: chronic PA colonization requiring maintenance therapy with inhaled tobramycin; • Age 6-18 years; • Ability to breathe through a mouthpiece and to use both types of inhalers; • Ability to perform lung function tests; • Written informed consent (parents; >12 years: child and parents). Are the trial subjects under 18? yes Number of subjects for this age range: 24 F.1.2 Adults (18-64 years) no 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: The criteria of exclusion will be the following: • Acute exacerbation of pulmonary infection; • Known impaired kidney function (estimated creatinine clearance < 60 ml/min); • Start of nephrotoxic or ototoxic drugs, e.g. aminoglycosides, within 1 month prior to start or during the study; • Therapy (e.g. furosemide) or disease which may complicate evaluation of the study protocol, as judged by the investigator; • Participation in another drug-investigating clinical study at the start or within 1 month prior to the start; • Inability to follow instructions of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether pharmacokinetics of the recommended dose of inhaled tobramycin, defined as serum tobramycin Area Under the Curve (AUC0-24hr), with the I-neb (75 mg) is equivalent to the PariLCPlus (300 mg) nebuliser in children with CF aged 6-18 years. ;Secondary Objective: 1) To assess safety of I-neb tobramycin inhalation therapy, 2) to compare pharmacokinetics of I-neb tobramycin inhalation in children with CF aged 6-11 years with children aged 12-18 years and 3) to compare patient compliance and satisfaction with both nebulisers.;Primary end point(s): Primary endpoint: systemic bioavailability of inhaled tobramycin, defined as serum tobramycin AUC0-24hr.;Timepoint(s) of evaluation of this end point: 1,5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints will include: • Change in hearing function (measured by HFPTA and DPOAE); • Change in NAG/creatinine ratio as measure of early renal toxicity; • Serum tobramycin peak and trough levels; • Change in FEV1 before and after nebulisation (safety parameter); • Compliance rate; • Patient satisfaction (use/cleaning of device); • Differences in AUC0-24 between age groups 6-11 and 12-18 years. ;Timepoint(s) of evaluation of this end point: 1,5 years | — |
Countries
Netherlands
Contacts
Public ContactHM Janssens
Erasmus University Medical Centre
Outcome results
None listed