Cystic Fibrosis Taaislijmziekte Inhaled antibiotics Inhalatie antibiotica Pseudomonas aeruginosa
Conditions
Interventions
Ten patients will be inhaling a double tobramycin dose twice at the outpatient clinic department in a cross-over setting: once with the Akita® nebulizer and the other time with the PARI-LC® Plus nebul
Sponsors
Erasmus MC, Rotterdam
Eligibility
Inclusion criteria
Inclusion criteria:  Age ≥ 18 years;  FEV1 predicted ≥ 30%;  Clinical diagnosis of CF and a positive sweat test or two CF-related mutations;  Chronic PA colonization;  Ability to breathe through a mouthpiece and to use the inhaler;  Ability to perform lung function tests;  Written informed consent.
Exclusion criteria
Exclusion criteria:  Severe acute exacerbation of pulmonary infection (needing intravenous treatment);  Patients receiving intravenous tobramycin treatment;  Patients who are pregnant, planning to become pregnant or breastfeeding;  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; NL46747.098.13 / TAPAS-PK-2014-amendment TAPAS-PK study in patients with CF Version 3.0 February 2014 15 of 35  Inability to follow instructions of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: systemic bioavailability of inhaled tobramycin, defined as serum tobramycin AUC0-24hr. | — |
Secondary
| Measure | Time frame |
|---|---|
|  Maximum tobramycin serum level (Cmax);  Time to maximum serum level (Tmax);  Trough level of inhaled tobramycin (Ctrough; 24 hours post dose);  Adverse events (coughing, bronchospasm). | — |
Contacts
Public ContactA.J. Velzen, van
HagaZiekenhuis Leyweg 275
Outcome results
None listed