Cystic Fibrosis Lung infections
Conditions
Interventions
Product Name: Dry powder tobramycin
Product Code: J01GB01
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: TOBRAMYCIN
Other descriptive name: TOBRAMYCIN
Concentration unit: mg milligram(s)
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Clinical diagnosis of CF and a positive sweat test or two CF-related mutations - Age 6 - 18 years - Ability to breathe through a mouthpiece and to use the Cyclops - Ability to perform pulmonary function tests - Written informed consent (child and parents) Are the trial subjects under 18? yes Number of subjects for this age range: 10 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: - Acute exacerbation - FEV1 < 60% - Subjects with known or suspected renal, auditory, vestibular of neuromuscular dysfunction, or with severe, active haemoptysis - History of adverse events on previous tobramycin or other amino glycoside use - History of adverse events on the use of powder inhaler - Concurrent use of cyclosporine, amphotericin B, cephalosporins, polymyxins, vancomycin and NSAID's
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the pharmacokinetic properties of dry powder tobramycin via the Cyclops® at different dosages in children with cystic fibrosis, together with the local tolerability.;Secondary Objective: Not applicable;Primary end point(s): The following pharmacokinetic parameters will be calculated: - AUC0 to 8-12 (area under the curve from 0 to 8-12 h);Timepoint(s) of evaluation of this end point: Within four weeks after the last test dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The following pharmacokinetic parameters will be calculated: - Actual dose (dose minus remainder in inhaler after inhalation) - Cmax (maximum plasma concentration) - Tmax (time to maximum plasma concentration) - Ka (absorption rate constant) - T 1/2 el (terminal elimination half-life) - CL/F (clearance following pulmonary administration (F= bioavailability)) Local tolerability of the inhalation of dry powder tobramycin. Both points need to have a positive result. - Drop of FEV1 of >10% (lung function measurement) - Adverse events;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Netherlands
Contacts
Public ContactPrincipal investigator AM Akkerman
University Medical Center Groningen
Outcome results
None listed