Cystic fibrosis
Conditions
Interventions
Trade Name: Bramitob
Pharmaceutical Form: Inhalation vapour, liquid
INN or Proposed INN: TOBRAMYCIN
CAS Number: 32986-56-4
Current Sponsor code: TAPAS-PK-2014
Other descriptive name: TOBRAMYCIN
Concen
Sponsors
Haga Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Age = 18 years; • FEV1 predicted = 30%; • Clinical diagnosis of CF and a positive sweat test or two CF-related mutations; • Chronic PA colonization requiring maintenance therapy with inhaled tobramycin; • Ability to breathe through a mouthpiece and to use the inhaler; • Ability to perform lung function tests; • Written informed consent. Are the trial subjects under 18? no 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 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Severe acute exacerbation of pulmonary infection (needing intravenous treatment); • Known impaired kidney function (estimated creatinine clearance < 60 ml/min); • Known aminoglycoside hypersensitivity; • 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 the pharmacokinetics of once daily inhalation of the recommended daily dose of tobramycin with the Akita® nebulizer, specifically targeted to the peripheral small airways, in patients with CF.;Secondary Objective: To compare data from primary objective to 1) pharmacokinetics of once daily tobramycin inhalation with the conventional and registered PARI-LC® Plus nebulizer and to 2) pharmacokinetic data from the literature about standard twice daily tobramycin inhalation with the PARI-LC® Plus.;Primary end point(s): Systemic bioavailability of inhaled tobramycin, defined as serum tobramycin AUC0-24hr.;Timepoint(s) of evaluation of this end point: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Serum tobramycin peak and trough levels; • Adverse events. ;Timepoint(s) of evaluation of this end point: 1 year | — |
Countries
Netherlands
Contacts
Public ContactAJ van Velzen
Haga Hospital
Outcome results
None listed